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A Study of Oral Gimatecan in Platinum-Resistant Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

Primary Purpose

Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Gimatecan
Sponsored by
Lee's Pharmaceutical Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring epithelial ovarian, fallopian tube or peritoneal cancer, Platinum resistant, chemotherapy, gimatecan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. The subjects were able to understand the informed consent, voluntarily participate in and sign the informed consent, with good compliance and cooperation with follow-up.
  2. A histopathological or cytological diagnosis of epithelial ovarian, fallopian tube or peritoneal cancer.
  3. Previous systematic treatment ≤ 2 lines, and progression in platinum based regimens or recurrence within 6 months after the end of platinum regimen. 1) Imaging progression of recurrence and progression should be clearly recorded;2) Neoadjuvant + adjuvant chemotherapy with platinum regimen ≥ 6 cycles, and platinum regimen after recurrence / progression ≥ 4 cycles;3) If there is progression during the treatment of platinum based regimen, the treatment cycle is not limited;4) Recurrence / progression within 6 months after the end of neoadjuvant / adjuvant therapy is considered to have received the first-line systematic treatment.
  4. Measurable cancer lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
  5. ≥18 years old;
  6. Eastern Cooperative Oncology Group(ECOG) performance status score 0-1;
  7. Estimated life expectancy >3 months;
  8. The function of important organs meets the following requirements:

    1. white blood cell count (WBC) ≥ 3.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90g/L;
    2. ALT, AST≤ 2.5×ULN; liver metastasis: ALT、AST≤ 5.0×ULN;
    3. serum albumin ≥ 28g/L;
    4. total bilirubin ≤ 1.5×ULN;
    5. serum creatinine ≤ 1.5×ULN, creatinine clearance rate ≥60 mL/min;
    6. PT≤ 1.5×ULN;
  9. The subjects had no history of allergy to camptothecin or its components;
  10. Non surgical sterilization or female subjects of childbearing age need to use a medically approved contraceptive method after signing the informed consent, during the study treatment period and within 6 months after the end of the study treatment period; non surgical sterilization female subjects of childbearing age must have negative blood HCG test within 3 days before entering the study; and they must be in non lactation period.
  11. Taking drugs orally;
  12. The subjects had recovered and treatment will start more than 4 weeks after the end of previous surgery, chemotherapy, targeted therapy and radiotherapy.

Exclusion Criteria:

  1. Subjects who have been treated previously with topotecan, Irinotecan or other topoisomerase I inhibitors;
  2. Other anticancer therapy including any investigational agent within 30 days prior to the first dose of the investigational drug gimatecan;
  3. Within 14 days before the first dose of the investigational drug gimatecan, any active infection requiring systemic anti infective treatment;
  4. Subjects with a history of major gastrointestinal surgery (e.g., total gastrectomy, small bowel resection) or gastrointestinal dysfunction that may alter drug absorption and activity in vivo;
  5. Severe cardiovascular disease, such as NYHA grade 3-4 heart failure;
  6. Patients who have been treated previously with intravenous or oral drugs that affect CYP isoenzymes within 7 days prior to the first dose of the investigational drug gimatecan;
  7. A history of immunodeficiency (including a positive HIV test result);Presence of active hepatitis B , hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay);
  8. Pleural effusion, pericardial effusion or ascites with clinical symptoms can not be controlled by puncture drainage or other treatment;
  9. Subjects with hereditary or acquired bleeding tendency (hemophilia, thrombocytopenia, etc.), interstitial pneumonia or pulmonary fibrosis, and active tuberculosis (whether or not treated) in the past year;
  10. Vaccinated with live attenuated vaccine within 4 weeks;
  11. Subjects had other active malignancies within 5 years before the first dose of the investigational drug gimatecan;
  12. Subjects with active meningeal metastasis or uncontrollable and untreated brain metastasis.
  13. Other considered unsuitable for the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Gimatecan group

    Arm Description

    In Phase II study, patients will receive gimatecan at fixed dose level (0.8mg/m2/d, oral, every 4 weeks) until progressive disease (PD)、complete remission(CR)).

    Outcomes

    Primary Outcome Measures

    Objective response rate (ORR)
    Percentage of patients with objective response assessed by best overall response (BOR) and independent review committee (IRC) of either complete response(CR) or partial remission(PR) will be reported.

    Secondary Outcome Measures

    Progression free survival (PFS)
    The 2-year progression free survival of the whole group.
    Disease control rate (DCR)
    will be reported.
    Duration of Response (DoR)
    The 2-year overall survival of the whole group.
    Overall survival (OS)
    The 2-year overall survival of the whole group.

    Full Information

    First Posted
    April 12, 2021
    Last Updated
    April 15, 2021
    Sponsor
    Lee's Pharmaceutical Limited
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04846842
    Brief Title
    A Study of Oral Gimatecan in Platinum-Resistant Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
    Official Title
    A Phase II Study of Gimatecan in the Treatment of Platinum-resistant Recurrent Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2021 (Anticipated)
    Primary Completion Date
    July 1, 2022 (Anticipated)
    Study Completion Date
    July 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lee's Pharmaceutical Limited

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This phase II clinical trial studies the safety and effect of Gimatecan in patients with platinum-resistant recurrent epithelial ovarian, fallopian tube or peritoneal cancer. The chemotherapy will be given every four weeks.This study is a single-arm, multi-center research design.
    Detailed Description
    The study had 3 phases: screening phase, treatment phase and follow-up phase. During the treatment phase, the drug will continue to be administered until the progression of disease, complete remission , unacceptable toxicity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
    Keywords
    epithelial ovarian, fallopian tube or peritoneal cancer, Platinum resistant, chemotherapy, gimatecan

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    46 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Gimatecan group
    Arm Type
    Experimental
    Arm Description
    In Phase II study, patients will receive gimatecan at fixed dose level (0.8mg/m2/d, oral, every 4 weeks) until progressive disease (PD)、complete remission(CR)).
    Intervention Type
    Drug
    Intervention Name(s)
    Gimatecan
    Other Intervention Name(s)
    ST1481
    Intervention Description
    Patients will receive gimatecan orally at the fixed dose level on day 1-5 every 4 weeks.
    Primary Outcome Measure Information:
    Title
    Objective response rate (ORR)
    Description
    Percentage of patients with objective response assessed by best overall response (BOR) and independent review committee (IRC) of either complete response(CR) or partial remission(PR) will be reported.
    Time Frame
    To evaluate objective response rate every 8 weeks after the initiation of chemotherapy, up to 24 months.
    Secondary Outcome Measure Information:
    Title
    Progression free survival (PFS)
    Description
    The 2-year progression free survival of the whole group.
    Time Frame
    From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.
    Title
    Disease control rate (DCR)
    Description
    will be reported.
    Time Frame
    To evaluate disease control rate every 8 weeks after the initiation of chemotherapy, up to 24 months.
    Title
    Duration of Response (DoR)
    Description
    The 2-year overall survival of the whole group.
    Time Frame
    From date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.
    Title
    Overall survival (OS)
    Description
    The 2-year overall survival of the whole group.
    Time Frame
    From date of randomization until the date of death from any cause or the date of last follow-up whichever came first, assessed up to 24 months.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The subjects were able to understand the informed consent, voluntarily participate in and sign the informed consent, with good compliance and cooperation with follow-up. A histopathological or cytological diagnosis of epithelial ovarian, fallopian tube or peritoneal cancer. Previous systematic treatment ≤ 2 lines, and progression in platinum based regimens or recurrence within 6 months after the end of platinum regimen. 1) Imaging progression of recurrence and progression should be clearly recorded;2) Neoadjuvant + adjuvant chemotherapy with platinum regimen ≥ 6 cycles, and platinum regimen after recurrence / progression ≥ 4 cycles;3) If there is progression during the treatment of platinum based regimen, the treatment cycle is not limited;4) Recurrence / progression within 6 months after the end of neoadjuvant / adjuvant therapy is considered to have received the first-line systematic treatment. Measurable cancer lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1; ≥18 years old; Eastern Cooperative Oncology Group(ECOG) performance status score 0-1; Estimated life expectancy >3 months; The function of important organs meets the following requirements: white blood cell count (WBC) ≥ 3.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L, platelets ≥ 100×109/L, hemoglobin ≥ 90g/L; ALT, AST≤ 2.5×ULN; liver metastasis: ALT、AST≤ 5.0×ULN; serum albumin ≥ 28g/L; total bilirubin ≤ 1.5×ULN; serum creatinine ≤ 1.5×ULN, creatinine clearance rate ≥60 mL/min; PT≤ 1.5×ULN; The subjects had no history of allergy to camptothecin or its components; Non surgical sterilization or female subjects of childbearing age need to use a medically approved contraceptive method after signing the informed consent, during the study treatment period and within 6 months after the end of the study treatment period; non surgical sterilization female subjects of childbearing age must have negative blood HCG test within 3 days before entering the study; and they must be in non lactation period. Taking drugs orally; The subjects had recovered and treatment will start more than 4 weeks after the end of previous surgery, chemotherapy, targeted therapy and radiotherapy. Exclusion Criteria: Subjects who have been treated previously with topotecan, Irinotecan or other topoisomerase I inhibitors; Other anticancer therapy including any investigational agent within 30 days prior to the first dose of the investigational drug gimatecan; Within 14 days before the first dose of the investigational drug gimatecan, any active infection requiring systemic anti infective treatment; Subjects with a history of major gastrointestinal surgery (e.g., total gastrectomy, small bowel resection) or gastrointestinal dysfunction that may alter drug absorption and activity in vivo; Severe cardiovascular disease, such as NYHA grade 3-4 heart failure; Patients who have been treated previously with intravenous or oral drugs that affect CYP isoenzymes within 7 days prior to the first dose of the investigational drug gimatecan; A history of immunodeficiency (including a positive HIV test result);Presence of active hepatitis B , hepatitis C (positive for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the assay); Pleural effusion, pericardial effusion or ascites with clinical symptoms can not be controlled by puncture drainage or other treatment; Subjects with hereditary or acquired bleeding tendency (hemophilia, thrombocytopenia, etc.), interstitial pneumonia or pulmonary fibrosis, and active tuberculosis (whether or not treated) in the past year; Vaccinated with live attenuated vaccine within 4 weeks; Subjects had other active malignancies within 5 years before the first dose of the investigational drug gimatecan; Subjects with active meningeal metastasis or uncontrollable and untreated brain metastasis. Other considered unsuitable for the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ZHOU QI
    Phone
    13708384529
    Email
    qizhou9128@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    ZHOU QI
    Organizational Affiliation
    Chongqing Tumor Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    19819917
    Citation
    Hurwitz JL, McCoy F, Scullin P, Fennell DA. New advances in the second-line treatment of small cell lung cancer. Oncologist. 2009 Oct;14(10):986-94. doi: 10.1634/theoncologist.2009-0026. Epub 2009 Oct 9.
    Results Reference
    result

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    A Study of Oral Gimatecan in Platinum-Resistant Epithelial Ovarian, Fallopian Tube or Peritoneal Cancer

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