NCT01206335

Open Label Study With OHR/AVR118 in Advanced Cancer Patients With Anorexia-Cachexia

A Phase II Open Label Study With OHR/AVR118 in Anorectic Patients With Recurrent or Advanced Malignancies

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Ohr Pharmaceutical Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anorexia
• Cancer Cachexia

Interventions

Type	Name	Description
DRUG	OHR/AVR118	OHR/AVR118 given subcutaneously at 4mL per day

Timeline

• Start date: 2010-09-01
• Primary completion: 2012-12-01
• Completion: 2013-02-01
• First posted: 2010-09-21
• Last updated: 2012-11-27

Locations

1 site across 1 country: Canada