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 Non-Taxane Chemotherapy
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Improved Physical function
Physical function will be assessed by stair climb power at Day 84.
Day 84
No
Domingo Rodriguez, MD
Study Director
GTx
United States: Food and Drug Administration
G300505
NCT01355497
July 2011
August 2013
Name | Location |
---|---|
Gabrail Cancer Center | Canton, Ohio 44718 |
GTx Investigative Site | Phoenix, Arizona 85032 |
GTx Investigative Site | La Mesa, California 91942 |
GTx Investigative Site | Aventura, Florida 33180 |
GTx Investigative Site | Springfield, Illinois 62703 |
GTx Investigative Site | Fort Wayne, Indiana 46825 |
GTx Investigative Site | Albany, New York 12208 |
GTx Investigative Site | Chapel Hill, North Carolina 27514 |
GTx Investigative Site | Cincinnati, Ohio 45212 |
GTx Investigative Site | Bala Cynwyd, Pennsylvania 19004 |
GTx Investigative Site | Myrtle Beach, South Carolina 29572 |
GTx Investigative Site | Memphis, Tennessee 38117 |
GTx Investigative Site | Arlington, Texas 76017 |
GTx Investigative Site | Birmingham, Alabama 35211 |
GTx Investigative Site | Ashland, Kentucky 41101 |
GTx Investigative Site | Concord, Massachusetts 01742 |
GTx Investigative Site | St Clair Shores, Michigan 48081 |
GTx Investigative Site | Tupelo, Mississippi 38801 |
GTx Investigative Site | Great Falls, Montana 59405 |
GTx Investigative Site | Portland, Oregon 97213 |
GTx Investigator | Flat Rock, North Carolina 28731 |