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Brief Title: Phase III Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC)
Official Title: Phase III, Randomized, Double-Blind, Placebo Controlled Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer on First Line Platinum Plus a Taxane Chemotherapy
Study ID: NCT01355484
Brief Summary: The purpose of this study is to determine if the investigational drug GTx-024 can help subjects with non-small cell lung cancer increase physical function and maintain or gain muscle, also called "lean body mass".
Detailed Description: This is a randomized, double-blind, placebo controlled, multicenter, multinational efficacy and safety study in subjects with non small cell lung cancer (NSCLC). 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 and physical function.
Minimum Age: 30 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
GTx Investigative Site, Birmingham, Alabama, United States
GTx Investigative Site, Long Beach, California, United States
GTx Investigative Site, Aventura, Florida, 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
GTx Investigative Site, Indianapolis, Indiana, United States
GTx Investigative Site, Ashland, Kentucky, United States
GTx Investigative Site, Concord, Massachusetts, United States
GTx Investigative Site, St Clair Shores, Michigan, United States
GTx Investigative Site, Tupelo, Mississippi, United States
GTx Investigative Site, Great Falls, Montana, United States
GTx Investigative Site, Rochester, New York, United States
GTx Investigative Site, Burlington, North Carolina, United States
GTx Investigative Site, Flat Rock, North Carolina, United States
GTx Investigative Site, Wilmington, North Carolina, United States
GTx Investigative Site, Winston Salem, North Carolina, United States
GTx Investigative Site, Canfield, Ohio, United States
Gabrail Cancer Center, Canton, Ohio, United States
GTx Investigative Site, Sandusky, Ohio, United States
GTx Investigative Site, Portland, Oregon, United States
GTx Investigative Site, Lancaster, Pennsylvania, United States
GTx Investigative Site, Spartanburg, South Carolina, United States
GTx Investigative Site, Round Rock, Texas, United States