NCT01355497

Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC) on First Line Platinum

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 330 (actual)
• Sponsor: GTx · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Muscle Wasting
• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	GTx-024	subjects will be randomized to receive GTx-024 3mg softgel for the duration of the trial.
DRUG	placebo	subject will receive matching placebo for the duration of the trial

Timeline

• Start date: 2011-07-01
• Primary completion: 2013-05-01
• Completion: 2014-06-01
• First posted: 2011-05-18
• Last updated: 2020-11-09
• Results posted: 2020-11-09

Locations

30 sites across 1 country: United States