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01
Overview
Phase 2, randomised, double-blind trial of enobosarm in cancer cachexia (3 arms), sponsored by GTx. Primary endpoint: Total Body Lean Mass at 4 months. Started May 2007; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
1 mg GTx-024
1 mg Enobosarm daily
3 mg GTx-024
3 mg Enobosarm daily
Placebo
Matching Placebo daily
03
Who it enrols
Patients with Stage 2-4 NSCLC, Colorectal, NHL, CLL, or Stage 3-4 Breast Cancer who have experienced >= 2% weight loss in the prior 6 months. Males must be >45 years, females must be postmenopausal.
04
Endpoints
Primary
Total Body Lean Mass
Secondary
Muscle Function (Performance) as Measured by Stair Climb
Total Body Weight
Total Body Fat Mass
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