The impact of less than 8% weight loss on overall survival in subjects with non-small cell lung cancer (NSCLC) treated in a phase IIb trial of GTx-024.

9117 Background: Cancer cachexia causes muscle wasting and decline in physical function. Studies show that NSCLC patients with weight loss at diagnosis have worse treatment outcomes and shorter overall survival. This muscle wasting and decline in function may have detrimental consequences early in the course of a patient’s malignancy, underscoring the importance of diagnosing and treating this condition at an early stage. We conducted a Phase IIb, randomized, double blind, placebo controlled, multi center study to evaluate the effect of GTx-024 on muscle wasting and physical function in patients with cancer cachexia. Methods: Subjects (n=159) were randomized to oral GTx-024 (1 or 3 mg) or placebo (pbo) daily for 16 weeks. Subjects were males >45 y and postmenopausal females, had experienced ≥2% weight loss in the 6 mths prior to randomization, had a BMI <35 and either NSCLC, colorectal cancer, non-Hodgkin lymphoma, chronic lymphocytic leukemia or breast cancer. The primary endpoint was change in total lea...