Open Label Study With OHR/AVR118 in Advanced Cancer Patients With Anorexia-Cachexia
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Open Label Study With OHR/AVR118 in Anorectic Patients With Recurrent or Advanced Malignancies|
- Alleviation of multiple cachexia symptoms [ Time Frame: Four weeks ] [ Designated as safety issue: No ]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.
- Impact on inflammatory markers and hormonal milieu [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Measurement of effects on Testosterone, TSH and C-Reactive protein
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||February 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
OHR/AVR118 given subcutaneously at 4mL per day
Other Name: AVR118
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.
|Ottawa Hospital Cancer Centre|
|Ottawa, Ontario, Canada, K1H 8L6|
|Principal Investigator:||Martin Chasen, MBChB||Ottawa Hospital Cancer Centre|