Cancer Clinical Trial
Official title:
A Phase II Double Blind, Placebo Controlled, Randomized, > Multicenter Study With AVR118 Solution in Patients With Advanced > Malignancies Who Are Not Candidates for Curative Chemotherapy.
The purpose of this study is to determine whether patients with advanced cancers who receive AVR118 solution for injection into the skin can achieve improvement in quality of life. Based on a study in patients with AIDS, possible benefits may include improved appetite and strength; weight gain; improved mood; and decreased fatigue. For the first three weeks, some patients receive AVR118, and others receive placebo (an injection expected to have no benefits). After three weeks, all patients will be offered the opportunity to take injections of 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. A Phase II, double blind study comparing treatment with AVR118 to placebo, followed by an open label phase treating all patients with AVR118, will enable the Sponsor to gather data on safety and efficacy of AVR118 in this patient population. Patients aged 18-80 with advanced cancers (excluding central nervous system [CNS] cancers) who are not receiving chemotherapy, or who are receiving single agent, third line (or beyond) chemotherapy, may be eligible to participate. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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