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Phase III Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC)

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: NCT01355484
Recruitment Status : Completed
First Posted : May 18, 2011
Results First Posted : March 3, 2016
Last Update Posted : March 3, 2016
Sponsor:
Information provided by (Responsible Party):
GTx

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Muscle Wasting
Non Small Cell Lung Cancer
Interventions Drug: GTx-024
Drug: placebo
Enrollment 321
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GTx-024 Placebo
Hide Arm/Group Description

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.

subject will receive placebo for the duration of the trial

placebo: subject will receive placebo for the duration of the trial

Period Title: Overall Study
Started 160 161
Completed 109 107
Not Completed 51 54
Arm/Group Title GTx-024 Placebo Total
Hide Arm/Group Description

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.

subject will receive placebo for the duration of the trial

placebo: subject will receive placebo for the duration of the trial

Total of all reporting groups
Overall Number of Baseline Participants 160 161 321
Hide Baseline Analysis Population Description
Subjects included in the Full Analysis Set
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 160 participants 161 participants 321 participants
60.5
(36 to 84)
62.0
(34 to 88)
61.0
(34 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants 161 participants 321 participants
Female
43
  26.9%
46
  28.6%
89
  27.7%
Male
117
  73.1%
115
  71.4%
232
  72.3%
1.Primary Outcome
Title Physical Function
Hide Description Measure is the percentage of subjects at day 84 with stair climb power change >=10% from their baseline value.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects included in the Full Analysis Set
Arm/Group Title GTx-024 Placebo
Hide Arm/Group Description:

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.

subject will receive placebo for the duration of the trial

placebo: subject will receive placebo for the duration of the trial

Overall Number of Participants Analyzed 160 161
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
29.4
(22.4 to 37.1)
24.2
(17.8 to 31.6)
2.Primary Outcome
Title Lean Body Mass
Hide Description Measure is the percentage of subjects at day 84 with lean body mass change >=0% from their baseline value.
Time Frame Day 84
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects included in the Full Analysis Set
Arm/Group Title GTx-024 Placebo
Hide Arm/Group Description:

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.

subject will receive placebo for the duration of the trial

placebo: subject will receive placebo for the duration of the trial

Overall Number of Participants Analyzed 160 161
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
41.9
(34.1 to 49.9)
30.4
(23.4 to 38.2)
Time Frame 1 year, 7 months
Adverse Event Reporting Description Initiation: 26 Oct 2011, Completion: 8 May 2013
 
Arm/Group Title GTx-024 Placebo
Hide Arm/Group Description

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.

subject will receive placebo for the duration of the trial

placebo: subject will receive placebo for the duration of the trial

All-Cause Mortality
GTx-024 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
GTx-024 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   56/160 (35.00%)      60/161 (37.27%)    
Blood and lymphatic system disorders     
Anaemia * 1  4/160 (2.50%)  4 5/161 (3.11%)  5
Neutropenia * 1  3/160 (1.88%)  4 4/161 (2.48%)  6
Febrile Neutropenia * 1  4/160 (2.50%)  4 2/161 (1.24%)  2
Thrombocytopenia * 1  1/160 (0.63%)  1 1/161 (0.62%)  1
Granulocytopenia * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Leukopenia * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Lymphopenia * 1  0/160 (0.00%)  0 1/161 (0.62%)  1
Cardiac disorders     
Atrial Fibrillation * 1  2/160 (1.25%)  2 0/161 (0.00%)  0
Cardiac Failure * 1  1/160 (0.63%)  1 1/161 (0.62%)  1
Cardio-Respiratory Arrest * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Cardiopulmonary Failure * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Myocardial Infarction * 1  0/160 (0.00%)  0 1/161 (0.62%)  1
Myocarditis * 1  0/160 (0.00%)  0 1/161 (0.62%)  1
Supraventricular Tachycardia * 1  0/160 (0.00%)  0 1/161 (0.62%)  1
Gastrointestinal disorders     
Nausea * 1  1/160 (0.63%)  1 2/161 (1.24%)  2
Vomiting * 1  1/160 (0.63%)  1 1/161 (0.62%)  1
Diarrhoea * 1  0/160 (0.00%)  0 1/161 (0.62%)  1
Duodenal Ulcer * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Dysphagia * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Gastric Haemorrhage * 1  0/160 (0.00%)  0 1/161 (0.62%)  1
Gastroduodenitis * 1  0/160 (0.00%)  0 1/161 (0.62%)  1
Oesophagitis * 1  0/160 (0.00%)  0 1/161 (0.62%)  1
Upper Gastrointestinal Haemorrhage * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
General disorders     
Disease Progression * 1  19/160 (11.88%)  20 16/161 (9.94%)  16
Condition Aggravated * 1  1/160 (0.63%)  1 2/161 (1.24%)  2
Death * 1  0/160 (0.00%)  0 2/161 (1.24%)  2
General Physical Health Deterioration * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Non-Cardiac Chest Pain * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Infections and infestations     
Pneumonia * 1  6/160 (3.75%)  6 4/161 (2.48%)  4
Urinary Tract Infection * 1  1/160 (0.63%)  1 1/161 (0.62%)  1
Abdominal Abscess * 1  0/160 (0.00%)  0 1/161 (0.62%)  1
Bronchitis * 1  0/160 (0.00%)  0 1/161 (0.62%)  1
Diverticulitis * 1  0/160 (0.00%)  0 1/161 (0.62%)  1
Infectious Pleural Effusion * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Neutropenic Sepsis * 1  0/160 (0.00%)  0 1/161 (0.62%)  1
Respiratory Tract Infection * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Staphylococcal Sepsis * 1  0/160 (0.00%)  0 1/161 (0.62%)  1
Viral Infection * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Injury, poisoning and procedural complications     
Radiation Oesophagitis * 1  1/160 (0.63%)  1 1/161 (0.62%)  1
Lower Limb Fracture * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Open Fracture * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Radiation Injury * 1  0/160 (0.00%)  0 1/161 (0.62%)  1
Radiation Pneumonitis * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Subdural Haematoma * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Investigations     
Neutrophil Count Decreased  1  1/160 (0.63%)  1 1/161 (0.62%)  1
Metabolism and nutrition disorders     
Dehydration * 1  1/160 (0.63%)  1 6/161 (3.73%)  7
Hypoglycaemia * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Hyponatraemia * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Hypovolaemia * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Metastases To Bone * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Metastases To Central Nervous System * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Metastases To Liver * 1  0/160 (0.00%)  0 1/161 (0.62%)  1
Metastases To Meninges * 1  0/160 (0.00%)  0 1/161 (0.62%)  1
Metastatic Pain * 1  0/160 (0.00%)  0 1/161 (0.62%)  1
Nervous system disorders     
Syncope * 1  2/160 (1.25%)  2 0/161 (0.00%)  0
Cerebral Infarction * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Cerebrovascular Accident * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Psychiatric disorders     
Completed Suicide * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Delusional Disorder, Persecutory Type * 1  0/160 (0.00%)  0 1/161 (0.62%)  1
Renal and urinary disorders     
Renal Failure * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Urinary Retention * 1  0/160 (0.00%)  0 1/161 (0.62%)  1
Respiratory, thoracic and mediastinal disorders     
Respiratory Failure * 1  2/160 (1.25%)  2 4/161 (2.48%)  4
Dyspnoea * 1  3/160 (1.88%)  4 2/161 (1.24%)  3
Haemoptysis * 1  3/160 (1.88%)  3 2/161 (1.24%)  3
Pleural Effusion * 1  2/160 (1.25%)  2 1/161 (0.62%)  1
Pulmonary Embolism * 1  2/160 (1.25%)  2 1/161 (0.62%)  1
Pulmonary Haemorrhage * 1  0/160 (0.00%)  0 3/161 (1.86%)  3
Chronic Obstructive Pulmonary Disease * 1  0/160 (0.00%)  0 2/161 (1.24%)  2
Pneumothorax * 1  1/160 (0.63%)  1 1/161 (0.62%)  1
Hydropneumothorax * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Surgical and medical procedures     
Abdominal Operation * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Vascular disorders     
Dee Vein Thrombosis * 1  0/160 (0.00%)  0 3/161 (1.86%)  3
Jugular Vein Thrombosis * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Orthostatic Hypertension * 1  0/160 (0.00%)  0 1/161 (0.62%)  1
Subclavian Artery Thrombosis * 1  0/160 (0.00%)  0 1/161 (0.62%)  1
Superior Vena Cava Syndrome * 1  0/160 (0.00%)  0 1/161 (0.62%)  1
Thrombosis * 1  0/160 (0.00%)  0 1/161 (0.62%)  1
Venous Thrombosis * 1  1/160 (0.63%)  1 0/161 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GTx-024 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   141/160 (88.13%)      144/161 (89.44%)    
Blood and lymphatic system disorders     
Anaemia * 1  46/160 (28.75%)  60 44/161 (27.33%)  62
Neutropenia * 1  20/160 (12.50%)  33 30/161 (18.63%)  44
Gastrointestinal disorders     
Nausea * 1  57/160 (35.63%)  118 52/161 (32.30%)  130
Vomiting * 1  29/160 (18.13%)  39 26/161 (16.15%)  38
Diarrhoea * 1  18/160 (11.25%)  33 24/161 (14.91%)  32
Constipation * 1  17/160 (10.63%)  19 11/161 (6.83%)  14
General disorders     
Disease Progression * 1  22/160 (13.75%)  24 32/161 (19.88%)  36
Asthenia * 1  33/160 (20.63%)  43 20/161 (12.42%)  31
Fatigue * 1  20/160 (12.50%)  36 22/161 (13.66%)  30
Pyrexia * 1  12/160 (7.50%)  14 14/161 (8.70%)  18
Chest Pain * 1  8/160 (5.00%)  10 12/161 (7.45%)  13
Infections and infestations     
Pneumonia * 1  8/160 (5.00%)  8 14/161 (8.70%)  15
Metabolism and nutrition disorders     
Decreased Appetite * 1  11/160 (6.88%)  21 27/161 (16.77%)  45
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  27/160 (16.88%)  49 22/161 (13.66%)  42
Myalgia * 1  13/160 (8.13%)  24 10/161 (6.21%)  21
Pain In Extremity * 1  13/160 (8.13%)  26 9/161 (5.59%)  19
Nervous system disorders     
Peripheral Sensory Neuropathy * 1  19/160 (11.88%)  23 9/161 (5.59%)  12
Neuropathy Peripheral * 1  10/160 (6.25%)  19 8/161 (4.97%)  10
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  21/160 (13.13%)  31 12/161 (7.45%)  16
Cough * 1  11/160 (6.88%)  12 14/161 (8.70%)  18
Haemoptysis * 1  7/160 (4.38%)  9 14/161 (8.70%)  17
Skin and subcutaneous tissue disorders     
Alopecia * 1  54/160 (33.75%)  58 52/161 (32.30%)  62
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.1)
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.

Provide Sponsor with an advance copy of any proposed results communication at least 60 days prior to the date of the planned submission or presentation and Sponsor shall have 60 days from receipt to request any changes. Sponsor may request a delay of up to 60 additional days.

The PI shall not present data until the earlier of Sponsor's publication of the results of all investigators participating in the Study or 18 months after completion of the Study at all participating sites.

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director, Clinical Operations
Organization: GTx Inc.
Phone: 1-901-261-3795
EMail: mdesordi@gtxinc.com
Layout table for additonal information
Responsible Party: GTx
ClinicalTrials.gov Identifier: NCT01355484    
Other Study ID Numbers: G300504
POWER1 ( Other Identifier: GTx )
First Submitted: May 12, 2011
First Posted: May 18, 2011
Results First Submitted: February 4, 2016
Results First Posted: March 3, 2016
Last Update Posted: March 3, 2016