A Phase II Open Label Study With OHR/AVR118 in Anorectic Patients With Recurrent or Advanced Malignancies
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Martin Chasen, MBChB
Ottawa Hospital Cancer Centre
Canada: Health Canada