Study of GTx-024 on Muscle Wasting (Cachexia) Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GTx
ClinicalTrials.gov Identifier:
NCT00467844
First received: April 30, 2007
Last updated: June 26, 2014
Last verified: June 2014
Results First Received: January 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition: Cachexia
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
No text entered.

Reporting Groups
  Description
GTx -024 1 mg
GTx-024 3 mg
3 mg of Placebo Placebo

Participant Flow:   Overall Study
    GTx -024     GTx-024     3 mg of Placebo  
STARTED     53     54     52  
COMPLETED     34     34     38  
NOT COMPLETED     19     20     14  



  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.
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Reporting Groups
  Description
GTx -024 1 mg
GTx-024 3 mg
3 mg of Placebo Placebo
Total Total of all reporting groups

Baseline Measures
    GTx -024     GTx-024     3 mg of Placebo     Total  
Number of Participants  
[units: participants]
  53     54     52     159  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     25     22     24     71  
>=65 years     28     32     28     88  
Age  
[units: years]
Mean ± Standard Deviation
  65.7  ± 10.03     66.3  ± 10.51     65.6  ± 8.73     65.9  ± 9.74  
Gender  
[units: participants]
       
Female     19     20     17     56  
Male     34     34     35     103  
Region of Enrollment  
[units: participants]
       
United States     39     37     36     112  
Argentina     14     17     16     47  



  Outcome Measures
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1.  Primary:   The Efficacy of GTx-024 on Total Body Lean Mass.   [ Time Frame: Baseline to Four Months ]
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Measure Type Primary
Measure Title The Efficacy of GTx-024 on Total Body Lean Mass.
Measure Description Change in total body lean mass as measured by dual energy x-ray absorptiometry (DEXA)from baseline to 4 months.
Time Frame Baseline to Four Months  
Safety Issue No  

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.
The number of participants were those subjects in the modified intent-to-treat population (defined as subjects with at least one post baseline DEXA for LBM) who had baseline and 4 month DEXA results for LBM (observed cases).

Reporting Groups
  Description
GTx-024 1 mg No text entered.
GTx-024 3 mg No text entered.
Placebo Placebo

Measured Values
    GTx-024 1 mg     GTx-024 3 mg     Placebo  
Number of Participants Analyzed  
[units: participants]
  32     34     34  
The Efficacy of GTx-024 on Total Body Lean Mass.  
[units: kg]
Median ( Full Range )
  1.55  
  ( -2.06 to 12.64 )  
  0.98  
  ( -4.84 to 11.54 )  
  0.02  
  ( -5.81 to 7.46 )  

No statistical analysis provided for The Efficacy of GTx-024 on Total Body Lean Mass.



2.  Secondary:   To Assess the Efficacy of GTx-024 on Muscle Function (Performance) as Measured by Stair Climb.   [ Time Frame: Four Months ]


  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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