Back to resultsConsolidation Therapy With Hu3S193 for Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Primary Purpose
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
Status
Terminated
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Monoclonal antibody Hu3S193
Sponsored by
About this trial
This is an interventional treatment trial for Fallopian Tube Cancer
Eligibility Criteria
Inclusion Criteria:
- The Informed Consent Form (ICF) must be signed before the performance of any study specific procedure or treatment.
- Female patients of >= 18 years of age.
- Relapsing ovarian adenocarcinoma, fallopian tubes or primary peritoneal who achieved a complete clinical response after the first treatment of relapse with platinum-based regimen. A complete response is defined as the absence of cancer related symptoms, normal physical exam, normal CA-125 (tumor marker) level, normal chest X-ray and CT-scan of abdomen/pelvis. Eligibility allows the presence of nonspecific findings as long as not showing clear evidence of disease such as: lymph node and/or soft tissue abnormalities <= 1.0 cm which are frequently present on the pelvis and will not be considered to be a conclusive evidence of disease.
- Expression of antigen Ley documented by immunohistochemistry of archived primary or metastatic tumor samples.
- The patient must have been submitted at least to hysterectomy and bilateral salpingo-oophorectomy before entering the study and must have received platinum-based chemotherapy as adjunctive or neo-adjunctive treatment at the first presentation.
- At least 5 and no more than 8 cycles of platinum combination therapy (i.e. doublet) as treatment for the first relapse.
- All side effects from chemotherapy must have been resolved or must be grade 1.
- Interval between the last dose of the treatment with platinum that achieved clinical CR (complete response) and the first dose of Hu3S193 =< 8 weeks.
- Karnofsky performance status >= 70%.
Results of laboratorial exams in the first 2 weeks before drug infusion within the following values:
- Absolute Neutrophil Count >= 1.5 x 10x3 / mm3
- Platelet count >= 100 x 10x3 / mm3
- Blood bilirubin <= 2.0 mg/dL
- Aspartate aminotransaminase (AST) and Alanine aminotransferase (ALT) <= 2.5 x upper limit of normal (ULN).
- Blood creatinine <= 2.0 mg/dL.
- Prothrombin time < 1.3 x control
- Expected survival >= 12 months.
- Patients must be willing to participate and be able to comply with the protocol throughout the study.
Exclusion Criteria:
- Mucinous or clear cell histology.
- Patients must not have received Bevacizumab as part of their treatment on relapse.
- Diagnosis of primary tumor relapse made exclusively based on elevated levels of serum CA-125 with values <2-fold the upper limit of normality.
- Concomitant use of systemic corticosteroids or immunosuppressive agents.
- Known CNS (central nervous system) involvement by tumor.
- Clinically significant heart disease (New York Heart Association Class III or IV).
- ECG indicating clinically significant arrhythmia.
- History of myocardial infarction within 6 months.
- Other serious diseases, (e.g.: serious infections requiring antibiotics, bleeding disorders, chronic inflammatory bowel disease, or diseases that may interfere in the obtainment of accurate study results).
- Radiotherapy treatment, radiopharmaceuticals (e.g. 32P), biological therapy, anti-estrogen therapy (including tamoxifen), immunotherapy or surgery within 4 weeks before the first administration of investigational product fail to recover from toxic effects of any of these therapies within 6 weeks prior to study inclusion.
- Exposure to any investigational product within 4 months prior to study inclusion.
- Previous treatment with a humanized murine antibody and/or fragment of such antibody.
- Previous history of tumor (excluding appropriately treated non-melanoma skin cancer or carcinoma in situ of the cervix or no evidence of disease within at least 5 years for previous breast cancer or stage I endometrial cancer).
Sites / Locations
- Núcleo de Oncologia da Bahia
- Cetus Hospital-Dia Oncologia Ltda - Filial Belo Horizonte
- Hospital Erasto Gaertner
- Hospital de Clínicas de Porto Alegre
- Hospital de Câncer de Barretos
- Fundação Amaral Carvalho
- Instituto do Câncer do Estado de São Paulo "Octávio Frias de Oliveira"
- Hospital Israelita Albert Einstein
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Monoclonal antibody hu3S193
Arm Description
Monoclonal antibody hu3S193 will be administered to 51 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.
Outcomes
Primary Outcome Measures
1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy
PFS2 is defined by the interval from the beginning of rescue platinum-based chemotherapy until documented disease progression or death for any cause while the patient was under study or during the prolonged follow-up period.
Disease progression is defined by appearance of any new lesion (measurable and non-measurable) by the RECIST criteria. Disease progression date is the date when a new lesion is documented.
Secondary Outcome Measures
1-year Disease Progression-free Survival Rate
Two-year Overall Survival Rate
Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.
Safety - Vital Signs - Heart Rate
Vital signs were assessed throughout the study treatment (consolidation therapy).Through study completion, an average of 27 weeks.
Safety - Vital Signs - Respiratory Rate
Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.
Safety - Vital Signs - Systolic and Diastolic Blood Pressure
Both parameters were assessed throughout the study treatment. Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.
Safety - Vital Signs - Temperature
Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Immune System Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Nervous System Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Investigations
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Infections and Infestations; Gastrointestinal Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Blood and Lymphatic System Disorders (Anaemia)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Psychiatric Disorders (Anxiety)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Vascular Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Cardiac Disorders; General Disorders and Administration Site Conditions; Respiratory, Thoracic and Mediastinal Disorders (Chest Pain)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Musculoskeletal and Connective Tissue Disorders (Chills)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Hepatobiliary Disorders; Injury, Poisoning and Procedural Complications (Hepatotoxicity)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Immune System Disorders; General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Infusion Related Reaction)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Immune System Disorders; Respiratory, Thoracic and Mediastinal Disorders
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Nervous System Disorders (Spinal Pain)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; Injury, Poisoning and Procedural Complications
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Psychiatric Disorders (Depression)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Renal and Urinary Disorders (Dysuria)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Renal and Urinary Disorders; Infections and Infestations (Urinary Tract Infection)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Reproductive System and Breast Disorders (Vulvovaginal Dryness)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders; Cardiac Disorders (Dyspnoea)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Injury, Poisoning and Procedural Complications
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Cardiac Disorders; Vascular Disorders; Nervous System Disorders (Dizziness)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders; Nervous System Disorders (Vertigo)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Endocrine Disorders; Metabolism and Nutrition Disorders (Hyperglycaemia)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Eye Disorders (Ocular Hyperaemia)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Pharyngitis)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Reproductive System and Breast Disorders; Renal and Urinary Disorders (Pelvic Pain)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Vascular Disorders (Anal Haemorrhage)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Hyperthermia)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Catheter Site Inflammation)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Immune System Disorders; Blood and Lymphatic System Disorders; Injury, Poisoning and Procedural Complications (Transfusion Reaction)
The incidence of adverse events (percentage of patients with at least one adverse event and serious adverse events (overall and with reasonable relationship)) was assessed for the safety population
Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Bronchitis)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Infections and Infestations; Renal and Urinary Disorders (Urinary Tract Infection Bacterial)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Investigations (Blood Cholesterol Increased)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Renal and Urinary Disorders (Flank Pain)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Nervous System Disorders; Psychiatric Disorders; Respiratory, Thoracic and Mediastinal Disorders (Hoarseness)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Psychiatric Disorders; Nervous System Disorders (Insomnia)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Infections and Infestations (Tinea Pedis)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Reproductive System and Breast Disorders (Vulvovaginal Pruritus)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Vascular Disorders; Gastrointestinal Disorders (Haemorrhoids)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Adverse Events (AEs) - Vascular Disorders; Respiratory, Thoracic and Mediastinal Disorders (Epistaxis)
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Incidence of Serious Adverse Events (SAEs) - Gastrointestinal Disorders
A SAE was defined as an AE that met one of the following conditions: Death during the protocol-defined surveillance period; Potentially fatal event (defined as a patient at immediate risk of death at the time of the event); An event requiring the patient's hospitalization or prolongation of an existing hospitalization during the protocol-defined surveillance period; An event resulting in congenital anomaly or birth defect; An event resulting in a persistent or significant disability/incapacity; Any other major medical event that did not result in death, was not life threatening, or did not require hospitalization, but that could be considered a SAE when, based on the appropriate medical judgment, it presented a risk for the patient and required medical or surgical intervention to prevent one of the outcomes listed above.
Incidence of Serious Adverse Events (SAEs) - Musculoskeletal and Connective Tissue Disorders - Hip Fracture
A SAE was defined as an AE that met one of the following conditions: Death during the protocol-defined surveillance period; Potentially fatal event (defined as a patient at immediate risk of death at the time of the event); An event requiring the patient's hospitalization or prolongation of an existing hospitalization during the protocol-defined surveillance period; An event resulting in congenital anomaly or birth defect; An event resulting in a persistent or significant disability/incapacity; Any other major medical event that did not result in death, was not life threatening, or did not require hospitalization, but that could be considered a SAE when, based on the appropriate medical judgment, it presented a risk for the patient and required medical or surgical intervention to prevent one of the outcomes listed above.
Overall Mean Pharmacokinetic (PK) Data (Minimum and Maximum Concentrations)
Cmax = Peak (postdosing) Hu3S193 plasma concentration. Cmin = Trough (predosing) Hu3S193 plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in μg/mL.
Two-year Overall Survival: Median Time to Death
Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01137071
Brief Title
Consolidation Therapy With Hu3S193 for Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Official Title
A Phase II Trial of Hu3S193 Consolidation Therapy for Patients With Relapsing Platinum-sensitive Ovarian, Primary Peritoneal and Fallopian Tubes Adenocarcinoma, Who Achieved a Second Complete Response
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Total number of pts expected to be enrolled would not be met.
Study Start Date
April 2011 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Recepta Biopharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
RATIONALE: Monoclonal antibodies, such as Hu3S193, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase II trial is studying how well Hu3S193 works as a consolidation therapy for women with relapsing platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.
Detailed Description
This is a phase II multicenter trial with Hu3S193 as a single agent in a consolidation strategy in patients with relapsing platinum-sensitive ovarian, primary peritoneal and fallopian tubes cancer who achieve a second Complete Response after a platinum-based chemotherapy after platinum-based chemotherapeutical regimen. Fifty-one (51) patients with relapsing platinum-sensitive ovarian, primary peritoneal or fallopian tubes adenocarcinoma will receive doses of 30 mg/m2 of Hu3S193 as a single agent every two weeks, in a total of 12 doses (treatment period duration: 23 weeks). After the treatment period, patients will be evaluated every 3 months for the first two years, and every 6 months for more 3 years, and then in an annual-basis until disease progression or death, whichever happens first.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Monoclonal antibody hu3S193
Arm Type
Experimental
Arm Description
Monoclonal antibody hu3S193 will be administered to 51 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.
Intervention Type
Biological
Intervention Name(s)
Monoclonal antibody Hu3S193
Intervention Description
30 mg/m2 of Monoclonal antibody Hu3S193, IV as a single agent every two weeks, in a total of 12 doses (treatment period duration: 23 weeks). Anti-Lewis Y humanized monoclonal antibody designated "orphan drug" by the FDA on March 09, 2012 for the treatment of ovarian cancer, not yet approved for the orphan designation.
Primary Outcome Measure Information:
Title
1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy
Description
PFS2 is defined by the interval from the beginning of rescue platinum-based chemotherapy until documented disease progression or death for any cause while the patient was under study or during the prolonged follow-up period.
Disease progression is defined by appearance of any new lesion (measurable and non-measurable) by the RECIST criteria. Disease progression date is the date when a new lesion is documented.
Time Frame
1-Year - From platinum-based rescue chemotherapy start date until documented disease progression or death of any cause whichever occurred first.
Secondary Outcome Measure Information:
Title
1-year Disease Progression-free Survival Rate
Time Frame
1 year from the beginning of platinum-based rescue chemotherapy start date
Title
Two-year Overall Survival Rate
Description
Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.
Time Frame
2-year overall survival rate after the beginning of rescue platinum-based chemotherapy.
Title
Safety - Vital Signs - Heart Rate
Description
Vital signs were assessed throughout the study treatment (consolidation therapy).Through study completion, an average of 27 weeks.
Time Frame
Baseline, week 2 , week 4 and week 27
Title
Safety - Vital Signs - Respiratory Rate
Description
Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.
Time Frame
Baseline, week 2, week 4 and week 27
Title
Safety - Vital Signs - Systolic and Diastolic Blood Pressure
Description
Both parameters were assessed throughout the study treatment. Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.
Time Frame
Baseline, week 2, week 4 and week 27
Title
Safety - Vital Signs - Temperature
Description
Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.
Time Frame
Baseline, week 2, week 4 and week 27
Title
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Immune System Disorders
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Nervous System Disorders
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Investigations
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Infections and Infestations; Gastrointestinal Disorders
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Blood and Lymphatic System Disorders (Anaemia)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Psychiatric Disorders (Anxiety)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Vascular Disorders
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Cardiac Disorders; General Disorders and Administration Site Conditions; Respiratory, Thoracic and Mediastinal Disorders (Chest Pain)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Musculoskeletal and Connective Tissue Disorders (Chills)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Hepatobiliary Disorders; Injury, Poisoning and Procedural Complications (Hepatotoxicity)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Immune System Disorders; General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Infusion Related Reaction)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Immune System Disorders; Respiratory, Thoracic and Mediastinal Disorders
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Nervous System Disorders (Spinal Pain)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; Injury, Poisoning and Procedural Complications
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Psychiatric Disorders (Depression)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Renal and Urinary Disorders (Dysuria)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Renal and Urinary Disorders; Infections and Infestations (Urinary Tract Infection)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Reproductive System and Breast Disorders (Vulvovaginal Dryness)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders; Cardiac Disorders (Dyspnoea)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Injury, Poisoning and Procedural Complications
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Cardiac Disorders; Vascular Disorders; Nervous System Disorders (Dizziness)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders; Nervous System Disorders (Vertigo)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Endocrine Disorders; Metabolism and Nutrition Disorders (Hyperglycaemia)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Eye Disorders (Ocular Hyperaemia)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Pharyngitis)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Reproductive System and Breast Disorders; Renal and Urinary Disorders (Pelvic Pain)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Vascular Disorders (Anal Haemorrhage)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Hyperthermia)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Catheter Site Inflammation)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Immune System Disorders; Blood and Lymphatic System Disorders; Injury, Poisoning and Procedural Complications (Transfusion Reaction)
Description
The incidence of adverse events (percentage of patients with at least one adverse event and serious adverse events (overall and with reasonable relationship)) was assessed for the safety population
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Bronchitis)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Infections and Infestations; Renal and Urinary Disorders (Urinary Tract Infection Bacterial)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Investigations (Blood Cholesterol Increased)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Renal and Urinary Disorders (Flank Pain)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Nervous System Disorders; Psychiatric Disorders; Respiratory, Thoracic and Mediastinal Disorders (Hoarseness)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Psychiatric Disorders; Nervous System Disorders (Insomnia)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Infections and Infestations (Tinea Pedis)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Reproductive System and Breast Disorders (Vulvovaginal Pruritus)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Vascular Disorders; Gastrointestinal Disorders (Haemorrhoids)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Adverse Events (AEs) - Vascular Disorders; Respiratory, Thoracic and Mediastinal Disorders (Epistaxis)
Description
The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Serious Adverse Events (SAEs) - Gastrointestinal Disorders
Description
A SAE was defined as an AE that met one of the following conditions: Death during the protocol-defined surveillance period; Potentially fatal event (defined as a patient at immediate risk of death at the time of the event); An event requiring the patient's hospitalization or prolongation of an existing hospitalization during the protocol-defined surveillance period; An event resulting in congenital anomaly or birth defect; An event resulting in a persistent or significant disability/incapacity; Any other major medical event that did not result in death, was not life threatening, or did not require hospitalization, but that could be considered a SAE when, based on the appropriate medical judgment, it presented a risk for the patient and required medical or surgical intervention to prevent one of the outcomes listed above.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Incidence of Serious Adverse Events (SAEs) - Musculoskeletal and Connective Tissue Disorders - Hip Fracture
Description
A SAE was defined as an AE that met one of the following conditions: Death during the protocol-defined surveillance period; Potentially fatal event (defined as a patient at immediate risk of death at the time of the event); An event requiring the patient's hospitalization or prolongation of an existing hospitalization during the protocol-defined surveillance period; An event resulting in congenital anomaly or birth defect; An event resulting in a persistent or significant disability/incapacity; Any other major medical event that did not result in death, was not life threatening, or did not require hospitalization, but that could be considered a SAE when, based on the appropriate medical judgment, it presented a risk for the patient and required medical or surgical intervention to prevent one of the outcomes listed above.
Time Frame
From the first infusion of medication to 30 days after the last one
Title
Overall Mean Pharmacokinetic (PK) Data (Minimum and Maximum Concentrations)
Description
Cmax = Peak (postdosing) Hu3S193 plasma concentration. Cmin = Trough (predosing) Hu3S193 plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in μg/mL.
Time Frame
Predose and Postdose on weeks 1, 2, 3, 4, 5, 7 and 9
Title
Two-year Overall Survival: Median Time to Death
Description
Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.
Time Frame
2-year overall survival rate after the beginning of rescue platinum-based chemotherapy.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The Informed Consent Form (ICF) must be signed before the performance of any study specific procedure or treatment.
Female patients of >= 18 years of age.
Relapsing ovarian adenocarcinoma, fallopian tubes or primary peritoneal who achieved a complete clinical response after the first treatment of relapse with platinum-based regimen. A complete response is defined as the absence of cancer related symptoms, normal physical exam, normal CA-125 (tumor marker) level, normal chest X-ray and CT-scan of abdomen/pelvis. Eligibility allows the presence of nonspecific findings as long as not showing clear evidence of disease such as: lymph node and/or soft tissue abnormalities <= 1.0 cm which are frequently present on the pelvis and will not be considered to be a conclusive evidence of disease.
Expression of antigen Ley documented by immunohistochemistry of archived primary or metastatic tumor samples.
The patient must have been submitted at least to hysterectomy and bilateral salpingo-oophorectomy before entering the study and must have received platinum-based chemotherapy as adjunctive or neo-adjunctive treatment at the first presentation.
At least 5 and no more than 8 cycles of platinum combination therapy (i.e. doublet) as treatment for the first relapse.
All side effects from chemotherapy must have been resolved or must be grade 1.
Interval between the last dose of the treatment with platinum that achieved clinical CR (complete response) and the first dose of Hu3S193 =< 8 weeks.
Karnofsky performance status >= 70%.
Results of laboratorial exams in the first 2 weeks before drug infusion within the following values:
Absolute Neutrophil Count >= 1.5 x 10x3 / mm3
Platelet count >= 100 x 10x3 / mm3
Blood bilirubin <= 2.0 mg/dL
Aspartate aminotransaminase (AST) and Alanine aminotransferase (ALT) <= 2.5 x upper limit of normal (ULN).
Blood creatinine <= 2.0 mg/dL.
Prothrombin time < 1.3 x control
Expected survival >= 12 months.
Patients must be willing to participate and be able to comply with the protocol throughout the study.
Exclusion Criteria:
Mucinous or clear cell histology.
Patients must not have received Bevacizumab as part of their treatment on relapse.
Diagnosis of primary tumor relapse made exclusively based on elevated levels of serum CA-125 with values <2-fold the upper limit of normality.
Concomitant use of systemic corticosteroids or immunosuppressive agents.
Known CNS (central nervous system) involvement by tumor.
Clinically significant heart disease (New York Heart Association Class III or IV).
ECG indicating clinically significant arrhythmia.
History of myocardial infarction within 6 months.
Other serious diseases, (e.g.: serious infections requiring antibiotics, bleeding disorders, chronic inflammatory bowel disease, or diseases that may interfere in the obtainment of accurate study results).
Radiotherapy treatment, radiopharmaceuticals (e.g. 32P), biological therapy, anti-estrogen therapy (including tamoxifen), immunotherapy or surgery within 4 weeks before the first administration of investigational product fail to recover from toxic effects of any of these therapies within 6 weeks prior to study inclusion.
Exposure to any investigational product within 4 months prior to study inclusion.
Previous treatment with a humanized murine antibody and/or fragment of such antibody.
Previous history of tumor (excluding appropriately treated non-melanoma skin cancer or carcinoma in situ of the cervix or no evidence of disease within at least 5 years for previous breast cancer or stage I endometrial cancer).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oren Smaletz, MD
Organizational Affiliation
Recepta Biopharma S.A.
Official's Role
Study Chair
Facility Information:
Facility Name
Núcleo de Oncologia da Bahia
City
Salvador
State/Province
Bahia
ZIP/Postal Code
40170-110
Country
Brazil
Facility Name
Cetus Hospital-Dia Oncologia Ltda - Filial Belo Horizonte
City
Belo Horizonte
State/Province
Minas Gerais
ZIP/Postal Code
30150-280
Country
Brazil
Facility Name
Hospital Erasto Gaertner
City
Curitiba
State/Province
Paraná
ZIP/Postal Code
81520-060
Country
Brazil
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Hospital de Câncer de Barretos
City
Barretos
State/Province
São Paulo
ZIP/Postal Code
14784-700
Country
Brazil
Facility Name
Fundação Amaral Carvalho
City
Jaú
State/Province
São Paulo
ZIP/Postal Code
17210-080
Country
Brazil
Facility Name
Instituto do Câncer do Estado de São Paulo "Octávio Frias de Oliveira"
City
São Paulo
ZIP/Postal Code
01246-000
Country
Brazil
Facility Name
Hospital Israelita Albert Einstein
City
São Paulo
ZIP/Postal Code
05651-901
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Recepta Biopharma understands the importance of individual-patient data (IPD) sharing and will include it in its future clinical studies; however, as this clinical study initiated in Apr-2011, an IPD was not planned.
Citations:
PubMed Identifier
33664128
Citation
Smaletz O, Ismael G, Del Pilar Estevez-Diz M, Nascimento ILO, de Morais ALG, Cunha-Junior GF, Azevedo SJ, Alves VA, Moro AM, Yeda FP, Dos Santos ML, Majumder I, Hoffman EW. Phase II consolidation trial with anti-Lewis-Y monoclonal antibody (hu3S193) in platinum-sensitive ovarian cancer after a second remission. Int J Gynecol Cancer. 2021 Apr;31(4):562-568. doi: 10.1136/ijgc-2020-002239. Epub 2021 Mar 4.
Results Reference
derived
Learn more about this trial
Consolidation Therapy With Hu3S193 for Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer
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