Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC) on First Line Platinum
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01355497|
Recruitment Status : Completed
First Posted : May 18, 2011
Last Update Posted : March 19, 2015
|Condition or disease||Intervention/treatment||Phase|
|Muscle Wasting Non-Small Cell Lung Cancer||Drug: GTx-024 Drug: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Non-Taxane Chemotherapy|
|Study Start Date :||July 2011|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||June 2014|
subjects will be randomized to receive GTx-024 for the duration of the trail
subjects will be randomized to receive GTx-024 for the duration of the trial.
Placebo Comparator: placebo
subjects will be randomized to receive placebo for the duration of the trial
subject will receive placebo for the duration of the trial
- Improved Physical function [ Time Frame: Day 84 ]Physical function will be assessed by stair climb power at Day 84.
- Increased lean body mass [ Time Frame: Day 84 ]At Day 84 a repeat Whole Body Composition Dexa Scan will be done and compared to the baseline Dexa.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01355497
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