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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
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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 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 
Overall Participants Analyzed 
[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 ]

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
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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       
# participants affected / at risk   3/53 (5.66%)   0/54 (0.00%)   0/52 (0.00%) 
# events      0   0 
Febrile Neutropenia       
# participants affected / at risk   2/53 (3.77%)   0/54 (0.00%)   3/52 (5.77%) 
# events      0    
Neutropenia       
# participants affected / at risk   1/53 (1.89%)   1/54 (1.85%)   0/52 (0.00%) 
# events         0 
Pancytopenia       
# participants affected / at risk   0/53 (0.00%)   0/54 (0.00%)   1/52 (1.92%) 
# events   0   0    
Thrombocytopenia       
# participants affected / at risk   0/53 (0.00%)   1/54 (1.85%)   0/52 (0.00%) 
# events   0      0 
Cardiac disorders       
Atrial Fibrillation       
# participants affected / at risk   1/53 (1.89%)   0/54 (0.00%)   0/52 (0.00%) 
# events      0   0 
Myocardial infarction       
# participants affected / at risk   1/53 (1.89%)   0/54 (0.00%)   0/52 (0.00%) 
# events      0   0 
Gastrointestinal disorders       
Diarrhoea       
# participants affected / at risk   1/53 (1.89%)   0/54 (0.00%)   0/52 (0.00%) 
# events      0   0 
Dysphagia       
# participants affected / at risk   0/53 (0.00%)   0/54 (0.00%)   1/52 (1.92%) 
# events   0   0    
gastric ulcer perforation       
# participants affected / at risk   0/53 (0.00%)   0/54 (0.00%)   1/52 (1.92%) 
# events   0   0    
lower gastrointestinal haemorrhage       
# participants affected / at risk   0/53 (0.00%)   1/54 (1.85%)   0/52 (0.00%) 
# events   0      0 
pancreatitis       
# participants affected / at risk   0/53 (0.00%)   0/54 (0.00%)   1/52 (1.92%) 
# events   0   0    
rectal obstruction       
# participants affected / at risk   0/53 (0.00%)   1/54 (1.85%)   0/52 (0.00%) 
# events   0      0 
small intestinal obstruction       
# participants affected / at risk   0/53 (0.00%)   0/54 (0.00%)   1/52 (1.92%) 
# events   0   0    
upper gastrointestinal haemorrhage       
# participants affected / at risk   0/53 (0.00%)   1/54 (1.85%)   0/52 (0.00%) 
# events   0      0 
Infections and infestations       
cellulitis       
# participants affected / at risk   0/53 (0.00%)   1/54 (1.85%)   0/52 (0.00%) 
# events   0      0 
diverticulitis       
# participants affected / at risk   0/53 (0.00%)   0/54 (0.00%)   1/52 (1.92%) 
# events   0   0    
pneumonia       
# participants affected / at risk   2/53 (3.77%)   3/54 (5.56%)   2/52 (3.85%) 
sepsis       
# participants affected / at risk   0/53 (0.00%)   0/54 (0.00%)   1/52 (1.92%) 
# events   0   0    
septic shock       
# participants affected / at risk   0/53 (0.00%)   1/54 (1.85%)   0/52 (0.00%) 
# events   0      0 
staphylococcal skin infection       
# 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       
# participants affected / at risk   0/53 (0.00%)   1/54 (1.85%)   0/52 (0.00%) 
# events   0      0 
hip fracture       
# participants affected / at risk   1/53 (1.89%)   0/54 (0.00%)   0/52 (0.00%) 
# events      0   0 
patella fracture       
# participants affected / at risk   1/53 (1.89%)   0/54 (0.00%)   1/52 (1.92%) 
# events      0    
road traffic accident       
# participants affected / at risk   0/53 (0.00%)   1/54 (1.85%)   0/52 (0.00%) 
# events   0      0 
Therapeutic agent toxicity       
# 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       
# 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       
# participants affected / at risk   0/53 (0.00%)   0/0   1/52 (1.92%) 
# events   0   0   1 
malignant neoplasm progression       
# participants affected / at risk   5/53 (9.43%)   7/54 (12.96%)   8/52 (15.38%) 
# events   6      9 
Metastases to central nervous system       
# participants affected / at risk   0/53 (0.00%)   1/54 (1.85%)   0/52 (0.00%) 
# events   0      0 
metastatic pain       
# participants affected / at risk   0/53 (0.00%)   1/54 (1.85%)   0/52 (0.00%) 
# events   0      0 
non small cell lung cancer       
# 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       
# 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       
# 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       
# participants affected / at risk   1/53 (1.89%)   0/54 (0.00%)   0/52 (0.00%) 
# events   1   0   0 
chronic obstructive pulmonary disease       
# participants affected / at risk   0/53 (0.00%)   1/54 (1.85%)   0/52 (0.00%) 
# events   0      0 
dyspnoea       
# 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


  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