The purpose of this study is to determine if the investigational drug GTx-024 can help patients with non small cell lung cancer increase physical function and maintain or gain muscle.
This is a randomized, double blind, placebo controlled, multicenter, multinational efficacy and safety study in subjects with non small cell lung cancer. Subjects will be evenly randomized to placebo or GTx-024 prior to initiation of first line chemotherapy. The primary efficacy analysis will be based on total Lean Body Mass (LBM) and physical function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
330
Physical Function
Measure is the percentage of subjects at day 84 with stair climb power change \>=10% from their baseline value.
Time frame: Day 84
Lean Body Mass
Measure is the percentage of subjects at day 84 with lean body mass change \>=0% from their baseline value.
Time frame: Day 84
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GTx Investigative Site
Birmingham, Alabama, United States
GTx Investigative Site
Scottsdale, Arizona, United States
GTx Investigative Site
La Jolla, California, United States
GTx Investigative Site
Long Beach, California, United States
GTx Investigative Site
Miami, Florida, United States
GTx Investigative Site
Orange City, Florida, United States
GTx Investigative Site
Tampa, Florida, United States
GTx Investigative Site
Decatur, Illinois, United States
GTx Investigative Site
Peoria, Illinois, United States
GTx Investigative Site
Skokie, Illinois, United States
...and 20 more locations