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Phase III Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01355484
First Posted: May 18, 2011
Last Update Posted: March 3, 2016
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.
Information provided by (Responsible Party):
GTx
Results First Submitted: February 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Muscle Wasting
Non Small Cell Lung Cancer
Interventions: Drug: GTx-024
Drug: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
GTx-024

subject will receive GTx-024 treatment for the duration of the trial

GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial.
Placebo

subject will receive placebo for the duration of the trial

placebo: subject will receive placebo for the duration of the trial

Participant Flow:   Overall Study
    GTx-024   Placebo
STARTED   160   161 
COMPLETED   109   107 
NOT COMPLETED   51   54 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects included in the Full Analysis Set

Reporting Groups
  Description
GTx-024

subject will receive GTx-024 treatment for the duration of the trial

GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial.
Placebo

subject will receive placebo for the duration of the trial

placebo: subject will receive placebo for the duration of the trial
Total Total of all reporting groups

Baseline Measures
   GTx-024   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 160   161   321 
Age 
[Units: Years]
Median (Full Range) 		 60.5 
 (36 to 84)  		 62.0 
 (34 to 88)  		 61.0 
 (34 to 88) 
Gender 
[Units: Participants]
 		     
Female   43   46   89 
Male   117   115   232 


  Outcome Measures
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1.  Primary:   Physical Function   [ Time Frame: Day 84 ]
  Show Outcome Measure 1

2.  Primary:   Lean Body Mass   [ Time Frame: Day 84 ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Senior Director, Clinical Operations
Organization: GTx Inc.
phone: 1-901-261-3795
e-mail: mdesordi@gtxinc.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: GTx
ClinicalTrials.gov Identifier: NCT01355484     History of Changes
Other Study ID Numbers: G300504
POWER1 ( Other Identifier: GTx )
First Submitted: May 12, 2011
First Posted: May 18, 2011
Results First Submitted: February 4, 2016
Results First Posted: March 3, 2016
Last Update Posted: March 3, 2016



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