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:
Information provided by (Responsible Party):
GTx
ClinicalTrials.gov Identifier:
NCT01355484
First received: May 12, 2011
Last updated: February 4, 2016
Last verified: February 2016
Results First Received: February 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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  
Number of Participants  
[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 ]

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


  Serious Adverse Events


  Other Adverse Events


  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



Responsible Party: GTx
ClinicalTrials.gov Identifier: NCT01355484     History of Changes
Other Study ID Numbers: G300504
POWER1 ( Other Identifier: GTx )
Study First Received: May 12, 2011
Results First Received: February 4, 2016
Last Updated: February 4, 2016
Health Authority: United States: Food and Drug Administration
Ukraine: Ministry of Health
Poland: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Hungary: Research Ethics Medical Committee
Chile: Ministry of Health
Peru: Ministry of Health
Argentina: Ministry of Health