Open Label Study With OHR/AVR118 in Advanced Cancer Patients With Anorexia-Cachexia
Primary Purpose
Anorexia, Cancer Cachexia
Status
Unknown status
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
OHR/AVR118
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia focused on measuring Cancer Cachexia, Anorexia, Advanced Malignancies, Weight Loss, Fatigue, Karnofsky, C-Reactive Protein, Simmonds Functional Assessment
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed solid tumor cancer, leukemia, lymphoma, or multiple myeloma.
- Concurrent anti-cancer treatment, such as chemotherapy or radiation therapy is permitted except for neo-adjuvant or adjuvant programs.
- Between the ages of 18-85.
- Symptoms of recurrent or metastatic cancer in which anorexia is a predominant symptom, not necessarily associated with cachexia, and are not attributed to anemia, concomitant illnesses, or obstruction or loss of organ function.
- Karnofsky performance status of 40%
- Palliative Prognostic Score (PaP) of less than 6
- Patient is expected to be able to remain on a study protocol for two months.
- Pretreatment laboratory data within 7 days of enrollment:
- Hemoglobin >8.5 g/dL , or on stable doses (hematocrit stable within 1 gram and dose stable for one month) of erythropoietin or similar medication.
- Absolute neutrophil count (ANC) 1,500/mm3.
- Platelets 50,000/mm3.
- Total bilirubin 2.0
- ALT and AST 2.5 times the ULN, or, if the patient has liver metastases, 5 times the ULN.
- Creatinine 1.5 mg/dL.
- Normal TSH
- Testosterone levels determined.
- Voluntary written informed consent before performance of any study-related procedure that is not part of normal medical care.
- Ability to self-administer subcutaneous medication if an assistant or nurse is not available, and to keep a compliance journal documenting injections at home.
- If on an antidepressant, the dose must have been stabilized for at least 30 days.
- Female patient is post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) for the duration of the study.
- Male patient agrees to use an acceptable barrier method for contraception during the study
Exclusion Criteria:
- Patient has uncontrolled brain metastases or central nervous system disease.
- Patient has mechanical, non-reversible reason for not being able to eat, or have a potential for developing malignant bowel obstruction during the course of the induction phase of treatment, or patients requiring a PEG for obstruction.
- Patient has had any major surgery within four weeks of enrollment.
- Patient has an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
- In the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
- Female patient is pregnant or breast-feeding.
Sites / Locations
- Ottawa Hospital Cancer Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OHR/AVR118
Arm Description
Experimental Drug
Outcomes
Primary Outcome Measures
Alleviation of multiple cachexia symptoms
Functional Status/Quality of Life as assessed by Simmonds Functional Assessment (SFA); Appetite and early satiety as assesed by patetient-generated subjective global assessment (PG-SGA), Edmonton Symptom assessment Scale (ESAS) and dyspepsia symptom severity index (DSSI); weight gain; increase in lean body mass.
Secondary Outcome Measures
Impact on inflammatory markers and hormonal milieu
Measurement of effects on Testosterone, TSH and C-Reactive protein
Full Information
NCT ID
NCT01206335
First Posted
September 20, 2010
Last Updated
November 26, 2012
Sponsor
Ohr Pharmaceutical Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01206335
Brief Title
Open Label Study With OHR/AVR118 in Advanced Cancer Patients With Anorexia-Cachexia
Official Title
A Phase II Open Label Study With OHR/AVR118 in Anorectic Patients With Recurrent or Advanced Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
February 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohr Pharmaceutical Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether patients with advanced cancers who receive OHR/AVR118 solution for injection into the skin can achieve improvement in quality of life. Based on a previous study in patients with AIDS, possible benefits may include improved appetite and strength; weight gain, improved mood; and decreased fatigue.
Detailed Description
Advanced cancers are usually debilitating. There are few treatments available for symptoms of advanced cancers like loss of appetite, decreased strength, fatigue, and change in mood. This Phase II, open label study with OHR/AVR118 will enable the Sponsor to gather data on safety and efficacy of OHR/AVR118 in the patient population with anorexia-cachexia. Patients aged 18-85 with advanced cancers (excluding central nervous system [CNS] cancers) who may or may not be receiving chemotherapy, may be eligible to participate. The study drug, 4.0 mL, will be given subcutaneously each day for 28 days. Patients who respond to the trial period dosing will be eligible to continue on OHR/AVR118 if they and their physicians believe it would be beneficial, and if no safety concerns are raised.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia, Cancer Cachexia
Keywords
Cancer Cachexia, Anorexia, Advanced Malignancies, Weight Loss, Fatigue, Karnofsky, C-Reactive Protein, Simmonds Functional Assessment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OHR/AVR118
Arm Type
Experimental
Arm Description
Experimental Drug
Intervention Type
Drug
Intervention Name(s)
OHR/AVR118
Other Intervention Name(s)
AVR118
Intervention Description
OHR/AVR118 given subcutaneously at 4mL per day
Primary Outcome Measure Information:
Title
Alleviation of multiple cachexia symptoms
Description
Functional Status/Quality of Life as assessed by Simmonds Functional Assessment (SFA); Appetite and early satiety as assesed by patetient-generated subjective global assessment (PG-SGA), Edmonton Symptom assessment Scale (ESAS) and dyspepsia symptom severity index (DSSI); weight gain; increase in lean body mass.
Time Frame
Four weeks
Secondary Outcome Measure Information:
Title
Impact on inflammatory markers and hormonal milieu
Description
Measurement of effects on Testosterone, TSH and C-Reactive protein
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically confirmed solid tumor cancer, leukemia, lymphoma, or multiple myeloma.
Concurrent anti-cancer treatment, such as chemotherapy or radiation therapy is permitted except for neo-adjuvant or adjuvant programs.
Between the ages of 18-85.
Symptoms of recurrent or metastatic cancer in which anorexia is a predominant symptom, not necessarily associated with cachexia, and are not attributed to anemia, concomitant illnesses, or obstruction or loss of organ function.
Karnofsky performance status of 40%
Palliative Prognostic Score (PaP) of less than 6
Patient is expected to be able to remain on a study protocol for two months.
Pretreatment laboratory data within 7 days of enrollment:
Hemoglobin >8.5 g/dL , or on stable doses (hematocrit stable within 1 gram and dose stable for one month) of erythropoietin or similar medication.
Absolute neutrophil count (ANC) 1,500/mm3.
Platelets 50,000/mm3.
Total bilirubin 2.0
ALT and AST 2.5 times the ULN, or, if the patient has liver metastases, 5 times the ULN.
Creatinine 1.5 mg/dL.
Normal TSH
Testosterone levels determined.
Voluntary written informed consent before performance of any study-related procedure that is not part of normal medical care.
Ability to self-administer subcutaneous medication if an assistant or nurse is not available, and to keep a compliance journal documenting injections at home.
If on an antidepressant, the dose must have been stabilized for at least 30 days.
Female patient is post-menopausal, surgically sterilized, or willing to use acceptable methods of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide, or abstinence) for the duration of the study.
Male patient agrees to use an acceptable barrier method for contraception during the study
Exclusion Criteria:
Patient has uncontrolled brain metastases or central nervous system disease.
Patient has mechanical, non-reversible reason for not being able to eat, or have a potential for developing malignant bowel obstruction during the course of the induction phase of treatment, or patients requiring a PEG for obstruction.
Patient has had any major surgery within four weeks of enrollment.
Patient has an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
In the Investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
Female patient is pregnant or breast-feeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Chasen, MBChB
Organizational Affiliation
Ottawa Hospital Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ottawa Hospital Cancer Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Open Label Study With OHR/AVR118 in Advanced Cancer Patients With Anorexia-Cachexia
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