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: November 13, 2013
Last verified: November 2013
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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.
No text entered.

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
  Show All Outcome Measures

1.  Primary:   The Efficacy of GTx-024 on Total Body Lean Mass.   [ Time Frame: Baseline to Four Months ]

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
  Hide Serious Adverse Events

Time Frame No text entered.
Additional Description No text entered.

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

Serious Adverse Events
    GTx -024     GTx-024     3 mg of Placebo  
Total, serious adverse events        
# participants affected / at risk     14/53 (26.42%)     15/54 (27.78%)     17/52 (32.69%)  
Blood and lymphatic system disorders        
Anaemia 1      
# participants affected / at risk     3/53 (5.66%)     0/54 (0.00%)     0/52 (0.00%)  
# events         0     0  
Febrile Neutropenia 1      
# participants affected / at risk     2/53 (3.77%)     0/54 (0.00%)     3/52 (5.77%)  
# events         0      
Neutropenia 1      
# participants affected / at risk     1/53 (1.89%)     1/54 (1.85%)     0/52 (0.00%)  
# events             0  
Pancytopenia 1      
# participants affected / at risk     0/53 (0.00%)     0/54 (0.00%)     1/52 (1.92%)  
# events     0     0      
Thrombocytopenia 1      
# participants affected / at risk     0/53 (0.00%)     1/54 (1.85%)     0/52 (0.00%)  
# events     0         0  
Cardiac disorders        
Atrial Fibrillation 1      
# participants affected / at risk     1/53 (1.89%)     0/54 (0.00%)     0/52 (0.00%)  
# events         0     0  
Myocardial infarction 1      
# participants affected / at risk     1/53 (1.89%)     0/54 (0.00%)     0/52 (0.00%)  
# events         0     0  
Gastrointestinal disorders        
Diarrhoea 1      
# participants affected / at risk     1/53 (1.89%)     0/54 (0.00%)     0/52 (0.00%)  
# events         0     0  
Dysphagia 1      
# participants affected / at risk     0/53 (0.00%)     0/54 (0.00%)     1/52 (1.92%)  
# events     0     0      
gastric ulcer perforation 1      
# participants affected / at risk     0/53 (0.00%)     0/54 (0.00%)     1/52 (1.92%)  
# events     0     0      
lower gastrointestinal haemorrhage 1      
# participants affected / at risk     0/53 (0.00%)     1/54 (1.85%)     0/52 (0.00%)  
# events     0         0  
pancreatitis 1      
# participants affected / at risk     0/53 (0.00%)     0/54 (0.00%)     1/52 (1.92%)  
# events     0     0      
rectal obstruction 1      
# participants affected / at risk     0/53 (0.00%)     1/54 (1.85%)     0/52 (0.00%)  
# events     0         0  
small intestinal obstruction 1      
# participants affected / at risk     0/53 (0.00%)     0/54 (0.00%)     1/52 (1.92%)  
# events     0     0      
upper gastrointestinal haemorrhage 1      
# participants affected / at risk     0/53 (0.00%)     1/54 (1.85%)     0/52 (0.00%)  
# events     0         0  
Infections and infestations        
cellulitis 1      
# participants affected / at risk     0/53 (0.00%)     1/54 (1.85%)     0/52 (0.00%)  
# events     0         0  
diverticulitis 1      
# participants affected / at risk     0/53 (0.00%)     0/54 (0.00%)     1/52 (1.92%)  
# events     0     0      
pneumonia 1      
# participants affected / at risk     2/53 (3.77%)     3/54 (5.56%)     2/52 (3.85%)  
sepsis 1      
# participants affected / at risk     0/53 (0.00%)     0/54 (0.00%)     1/52 (1.92%)  
# events     0     0      
septic shock 1      
# participants affected / at risk     0/53 (0.00%)     1/54 (1.85%)     0/52 (0.00%)  
# events     0         0  
staphylococcal skin infection 1      
# participants affected / at risk     0/53 (0.00%)     0/54 (0.00%)     1/52 (1.92%)  
# events     0     0      
Injury, poisoning and procedural complications        
compression fracture 1      
# participants affected / at risk     0/53 (0.00%)     1/54 (1.85%)     0/52 (0.00%)  
# events     0         0  
hip fracture 1      
# participants affected / at risk     1/53 (1.89%)     0/54 (0.00%)     0/52 (0.00%)  
# events         0     0  
patella fracture 1      
# participants affected / at risk     1/53 (1.89%)     0/54 (0.00%)     1/52 (1.92%)  
# events         0      
road traffic accident 1      
# participants affected / at risk     0/53 (0.00%)     1/54 (1.85%)     0/52 (0.00%)  
# events     0         0  
Therapeutic agent toxicity 1      
# participants affected / at risk     0/53 (0.00%)     0/54 (0.00%)     0/52 (0.00%)  
# events     0     0     0  
Metabolism and nutrition disorders        
diabetes mellitus 1      
# participants affected / at risk     1/53 (1.89%)     0/54 (0.00%)     0/52 (0.00%)  
# events     1     0     0  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)        
lung neoplasm malignant 1      
# participants affected / at risk     0/53 (0.00%)     0/0 (0.00%)     1/52 (1.92%)  
# events     0     0     1  
malignant neoplasm progression 1      
# participants affected / at risk     5/53 (9.43%)     7/54 (12.96%)     8/52 (15.38%)  
# events     6         9  
Metastases to central nervous system 1      
# participants affected / at risk     0/53 (0.00%)     1/54 (1.85%)     0/52 (0.00%)  
# events     0         0  
metastatic pain 1      
# participants affected / at risk     0/53 (0.00%)     1/54 (1.85%)     0/52 (0.00%)  
# events     0         0  
non small cell lung cancer 1      
# participants affected / at risk     1/53 (1.89%)     0/54 (0.00%)     1/52 (1.92%)  
# events     1     0     1  
Nervous system disorders        
brain stem infarction 1      
# participants affected / at risk     1/53 (1.89%)     0/54 (0.00%)     0/52 (0.00%)  
# events     1     0     0  
Renal and urinary disorders        
renal failure acute 1      
# participants affected / at risk     1/53 (1.89%)     0/54 (0.00%)     0/52 (0.00%)  
# events     1     0     0  
Respiratory, thoracic and mediastinal disorders        
acute pulmonary oedema 1      
# participants affected / at risk     1/53 (1.89%)     0/54 (0.00%)     0/52 (0.00%)  
# events     1     0     0  
chronic obstructive pulmonary disease 1      
# participants affected / at risk     0/53 (0.00%)     1/54 (1.85%)     0/52 (0.00%)  
# events     0         0  
dyspnoea 1      
# participants affected / at risk     1/53 (1.89%)     0/54 (0.00%)     0/52 (0.00%)  
# events     1     0     0  
1 Term from vocabulary, MedDRA (10.0)




  Other Adverse Events


  More Information
  Hide More Information

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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Vice President of Clinical Operations
Organization: GTx Inc.
phone: 901-523-9700 ext 289
e-mail: drodriguez@gtxinc.com


No publications provided by GTx

Publications automatically indexed to this study:

Responsible Party: GTx
ClinicalTrials.gov Identifier: NCT00467844     History of Changes
Obsolete Identifiers: NCT00832104
Other Study ID Numbers: G200502
Study First Received: April 30, 2007
Results First Received: January 18, 2013
Last Updated: November 13, 2013
Health Authority: United States: Food and Drug Administration