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Trial record 52 of 54 for:    colon cancer | ( Map: Mississippi, United States )

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

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.
ClinicalTrials.gov Identifier: NCT00467844
Recruitment Status : Completed
First Posted : May 1, 2007
Results First Posted : February 21, 2013
Last Update Posted : July 11, 2014
Sponsor:
Information provided by (Responsible Party):
GTx

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Condition Cachexia
Interventions Drug: GTx-024
Drug: Placebo
Enrollment 159
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GTx -024 GTx-024 3 mg of Placebo
Hide Arm/Group Description 1 mg 3 mg Placebo
Period Title: Overall Study
Started 53 54 52
Completed 34 34 38
Not Completed 19 20 14
Arm/Group Title GTx -024 GTx-024 3 mg of Placebo Total
Hide Arm/Group Description 1 mg 3 mg Placebo Total of all reporting groups
Overall Number of Baseline Participants 53 54 52 159
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 54 participants 52 participants 159 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
  47.2%
22
  40.7%
24
  46.2%
71
  44.7%
>=65 years
28
  52.8%
32
  59.3%
28
  53.8%
88
  55.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants 54 participants 52 participants 159 participants
65.7  (10.03) 66.3  (10.51) 65.6  (8.73) 65.9  (9.74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 54 participants 52 participants 159 participants
Female
19
  35.8%
20
  37.0%
17
  32.7%
56
  35.2%
Male
34
  64.2%
34
  63.0%
35
  67.3%
103
  64.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants 54 participants 52 participants 159 participants
United States 39 37 36 112
Argentina 14 17 16 47
1.Primary Outcome
Title The Efficacy of GTx-024 on Total Body Lean Mass.
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title GTx-024 1 mg GTx-024 3 mg Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Placebo
Overall Number of Participants Analyzed 32 34 34
Median (Full Range)
Unit of Measure: kg
1.55
(-2.06 to 12.64)
0.98
(-4.84 to 11.54)
0.02
(-5.81 to 7.46)
2.Secondary Outcome
Title To Assess the Efficacy of GTx-024 on Muscle Function (Performance) as Measured by Stair Climb.
Hide Description Change in stair climb power from baseline to 4 months. Stair climb power is defined power (watts)=[9.8 m/sec**2]*[weight (kg)]*[height of 12 steps(meters)]/ [time (seconds) up the 12 steps].
Time Frame Four Months
Hide Outcome Measure Data
Hide Analysis Population Description
The subjects were in the MITT population (had a post baseline DEXA) and had a month 4 stair climb assessment (observed cases).
Arm/Group Title GTx -024 GTx-024 3 mg of Placebo
Hide Arm/Group Description:
1 mg
3 mg
Placebo
Overall Number of Participants Analyzed 31 28 36
Median (Full Range)
Unit of Measure: watts
19.93
(-235.3 to 110.1)
12.84
(-77.7 to 93.1)
11.34
(-156.4 to 56.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GTx -024 GTx-024 3 mg of Placebo
Hide Arm/Group Description 1 mg 3 mg Placebo
All-Cause Mortality
GTx -024 GTx-024 3 mg of Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
GTx -024 GTx-024 3 mg of Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/53 (26.42%)      15/54 (27.78%)      17/52 (32.69%)    
Blood and lymphatic system disorders       
Anaemia  3/53 (5.66%)  0/54 (0.00%)  0 0/52 (0.00%)  0
Febrile Neutropenia  2/53 (3.77%)  0/54 (0.00%)  0 3/52 (5.77%) 
Neutropenia  1/53 (1.89%)  1/54 (1.85%)  0/52 (0.00%)  0
Pancytopenia  0/53 (0.00%)  0 0/54 (0.00%)  0 1/52 (1.92%) 
Thrombocytopenia  0/53 (0.00%)  0 1/54 (1.85%)  0/52 (0.00%)  0
Cardiac disorders       
Atrial Fibrillation  1/53 (1.89%)  0/54 (0.00%)  0 0/52 (0.00%)  0
Myocardial infarction  1/53 (1.89%)  0/54 (0.00%)  0 0/52 (0.00%)  0
Gastrointestinal disorders       
Diarrhoea  1/53 (1.89%)  0/54 (0.00%)  0 0/52 (0.00%)  0
Dysphagia  0/53 (0.00%)  0 0/54 (0.00%)  0 1/52 (1.92%) 
gastric ulcer perforation  0/53 (0.00%)  0 0/54 (0.00%)  0 1/52 (1.92%) 
lower gastrointestinal haemorrhage  0/53 (0.00%)  0 1/54 (1.85%)  0/52 (0.00%)  0
pancreatitis  0/53 (0.00%)  0 0/54 (0.00%)  0 1/52 (1.92%) 
rectal obstruction  0/53 (0.00%)  0 1/54 (1.85%)  0/52 (0.00%)  0
small intestinal obstruction  0/53 (0.00%)  0 0/54 (0.00%)  0 1/52 (1.92%) 
upper gastrointestinal haemorrhage  0/53 (0.00%)  0 1/54 (1.85%)  0/52 (0.00%)  0
Infections and infestations       
cellulitis  0/53 (0.00%)  0 1/54 (1.85%)  0/52 (0.00%)  0
diverticulitis  0/53 (0.00%)  0 0/54 (0.00%)  0 1/52 (1.92%) 
pneumonia  2/53 (3.77%)  3/54 (5.56%)  2/52 (3.85%) 
sepsis  0/53 (0.00%)  0 0/54 (0.00%)  0 1/52 (1.92%) 
septic shock  0/53 (0.00%)  0 1/54 (1.85%)  0/52 (0.00%)  0
staphylococcal skin infection  0/53 (0.00%)  0 0/54 (0.00%)  0 1/52 (1.92%) 
Injury, poisoning and procedural complications       
compression fracture  0/53 (0.00%)  0 1/54 (1.85%)  0/52 (0.00%)  0
hip fracture  1/53 (1.89%)  0/54 (0.00%)  0 0/52 (0.00%)  0
patella fracture  1/53 (1.89%)  0/54 (0.00%)  0 1/52 (1.92%) 
road traffic accident  0/53 (0.00%)  0 1/54 (1.85%)  0/52 (0.00%)  0
Therapeutic agent toxicity  0/53 (0.00%)  0 0/54 (0.00%)  0 0/52 (0.00%)  0
Metabolism and nutrition disorders       
diabetes mellitus  1/53 (1.89%)  1 0/54 (0.00%)  0 0/52 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
lung neoplasm malignant  0/53 (0.00%)  0 0/0  0 1/52 (1.92%)  1
malignant neoplasm progression  5/53 (9.43%)  6 7/54 (12.96%)  8/52 (15.38%)  9
Metastases to central nervous system  0/53 (0.00%)  0 1/54 (1.85%)  0/52 (0.00%)  0
metastatic pain  0/53 (0.00%)  0 1/54 (1.85%)  0/52 (0.00%)  0
non small cell lung cancer  1/53 (1.89%)  1 0/54 (0.00%)  0 1/52 (1.92%)  1
Nervous system disorders       
brain stem infarction  1/53 (1.89%)  1 0/54 (0.00%)  0 0/52 (0.00%)  0
Renal and urinary disorders       
renal failure acute  1/53 (1.89%)  1 0/54 (0.00%)  0 0/52 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
acute pulmonary oedema  1/53 (1.89%)  1 0/54 (0.00%)  0 0/52 (0.00%)  0
chronic obstructive pulmonary disease  0/53 (0.00%)  0 1/54 (1.85%)  0/52 (0.00%)  0
dyspnoea  1/53 (1.89%)  1 0/54 (0.00%)  0 0/52 (0.00%)  0
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GTx -024 GTx-024 3 mg of Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   47/53 (88.68%)      49/54 (90.74%)      46/52 (88.46%)    
Blood and lymphatic system disorders       
anaemia  13/53 (24.53%)  7/54 (12.96%)  8/52 (15.38%) 
neutropenia  3/53 (5.66%)  5/54 (9.26%)  2/52 (3.85%) 
thrombocytopenia  3/53 (5.66%)  5/54 (9.26%)  3/52 (5.77%) 
Gastrointestinal disorders       
abdominal pain  2/53 (3.77%)  8/54 (14.81%)  3/52 (5.77%) 
constipation  9/53 (16.98%)  6/54 (11.11%)  2/52 (3.85%) 
diarrhoea  8/53 (15.09%)  9/54 (16.67%)  7/52 (13.46%) 
vomiting  9/53 (16.98%)  4/54 (7.41%)  6/52 (11.54%) 
asthenia  1/53 (1.89%)  7/54 (12.96%)  4/52 (7.69%) 
fatigue  8/53 (15.09%)  14/54 (25.93%)  11/52 (21.15%) 
Nausea  13/53 (24.53%)  6/54 (11.11%)  7/52 (13.46%) 
General disorders       
pyrexia  5/53 (9.43%)  8/54 (14.81%)  3/52 (5.77%) 
Infections and infestations       
pneumonia  2/53 (3.77%)  4/54 (7.41%)  2/52 (3.85%) 
Investigations       
weight decreased  5/53 (9.43%)  8/54 (14.81%)  5/52 (9.62%) 
Metabolism and nutrition disorders       
anorexia  5/53 (9.43%)  5 6/54 (11.11%)  2/52 (3.85%)  2
dehydration  1/53 (1.89%)  1 7/54 (12.96%)  7 6/52 (11.54%)  6
Musculoskeletal and connective tissue disorders       
back pain  5/53 (9.43%)  5 1/54 (1.85%)  1 3/52 (5.77%)  4
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
malignant neoplasm progression  6/53 (11.32%)  8 8/54 (14.81%)  8 8/52 (15.38%)  9
Nervous system disorders       
headache  3/53 (5.66%)  3 5/54 (9.26%)  7 1/52 (1.92%)  1
Respiratory, thoracic and mediastinal disorders       
cough  2/53 (3.77%)  2 9/54 (16.67%)  9 6/52 (11.54%)  6
dyspnoea  7/53 (13.21%)  8 4/54 (7.41%)  6 5/52 (9.62%)  5
1
Term from vocabulary, MedDRA (10.0)
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.
Results Point of Contact
Name/Title: Senior Director, Clinical Operations
Organization: GTx Inc.
Phone: 901-523-9700
Responsible Party: GTx
ClinicalTrials.gov Identifier: NCT00467844     History of Changes
Obsolete Identifiers: NCT00832104
Other Study ID Numbers: G200502
First Submitted: April 30, 2007
First Posted: May 1, 2007
Results First Submitted: January 18, 2013
Results First Posted: February 21, 2013
Last Update Posted: July 11, 2014