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

Brief Summary:
The purpose of this study is to determine if the investigational drug GTx-024 can help subjects with non-small cell lung cancer increase physical function and maintain or gain muscle, also called "lean body mass".

Condition or disease Intervention/treatment Phase
Muscle Wasting Non Small Cell Lung Cancer Drug: GTx-024 Drug: placebo Phase 3

Detailed Description:
This is a randomized, double-blind, placebo controlled, multicenter, multinational efficacy and safety study in subjects with non small cell lung cancer (NSCLC). Subjects will be evenly randomized to placebo or GTx-024 prior to initiation of first line chemotherapy. The primary efficacy analysis will be based on total lean body mass and physical function.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 321 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase III, Randomized, Double-Blind, Placebo Controlled Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer on First Line Platinum Plus a Taxane Chemotherapy
Study Start Date : July 2011
Actual Primary Completion Date : May 2013
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Enobosarm

Arm Intervention/treatment
Experimental: GTx-024
subject will receive GTx-024 treatment for the duration of the trial
Drug: GTx-024
subjects will be randomized to receive GTx-024 for the full duration of the trial.

Placebo Comparator: Placebo
subject will receive placebo for the duration of the trial
Drug: placebo
subject will receive placebo for the duration of the trial

Primary Outcome Measures :
  1. Physical Function [ Time Frame: Day 84 ]
    Measure is the percentage of subjects at day 84 with stair climb power change >=10% from their baseline value.

  2. Lean Body Mass [ Time Frame: Day 84 ]
    Measure is the percentage of subjects at day 84 with lean body mass change >=0% from their baseline value.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • give voluntary, signed informed consent in accordance with institutional policies
  • be non-obese as defined as body mass index (BMI)< or = to 32 and weight <300 pounds (<136kg)
  • have been diagnosed with Stage III or IV NSCLC
  • be prior to first line chemotherapy
  • planned first line chemotherapy regimen is platinum plus paclitaxel only or platinum plus docetaxel only
  • if surgery is part of the cancer treatment, screening for this study should be conducted at least 4 weeks (28 days) after surgery
  • life expectancy of >6 months
  • ECOG score <or=1
  • Serum creatinine <or=2.0 mg/dL
  • MALES - age >or= 30 years
  • FEMALES - age >or=30 years and clinically confirmed as postmenopausal.Subjects must have undergone the onset of spontaneous or surgical menopause prior to the start of this study. Spontaneous menopause is defined as the natural cessation of ovarian function as indicated by being amenorrheic for at least 12 months. If the subject has been amenorrheic for >or=6 months but <12 months they must have a serum FSH concentration of >or=50 mIU/mL and an estradiol concentration of <or=25 pg/mL. Surgical menopause is defined as bilateral oophorectomy.
  • MALES - subjects must agree to use a double barrier method of contraception during the study and for 3 months after study completion. This may include the following: condom + spermicide or condom + oral hormonal contraception
  • MALES - have a serum PSA of <or=4.0 ng/mL or a negative prostate biopsy (no prostate cancer)within 6 months of evaluation

Exclusion Criteria:

  • Have, in the judgment of the investigator, a clinically significant concurrent illness or psychological, familial, sociological, geographical or other concomitant condition that would not permit adequate follow-up and compliance with the study protocol
  • Have ALT/SGOT or AST/SGPT above 1.5 times the upper limit of normal (ULN) without evidence of liver metastases and above 5 times the ULN in subjects with evidence of liver metastases
  • Have alkaline phosphatase greater than 3 times ULN and/or total bilirubin levels above 2 mg/dL at baseline
  • Have biologic agents or kinase inhibitors as part of their first line chemotherapy regimen including, but not limited to bevacizumab (Avastin), gefitinib (Nexavar) and erlotinib (Tarceva)
  • Cardiovascular: uncontrolled hypertension, congestive heart failure or angina
  • Pulmonary: Stage 4 chronic obstructive pulmonary disease (COPD)
  • positive screen for Hepatitis B consisting of HBsAg (Hepatitis B Surface Antigen), unless subject was diagnosed > 10 years prior to enrollment and no evidence of active liver disease
  • positive screen for anti-HCV (Hepatitis C Antibody),hepatitis A antibody IgM, or HIV
  • currently taking testosterone, oxandrolone (Oxandrin), testosterone-like agents (such as dehydroepiandrosterone (DHEA), androstenedione, and other androgenic compounds, including herbals), or antiandrogens; previous therapy with testosterone and testosterone-like agents is acceptable with a 30 day washout (if previous testosterone therapy was long term depot within the past 6 months, the site should contact the medical monitor for this study to determine appropriate washout period)
  • currently taking megestrol acetate (Megace), dronabinol (Marinol), medical marijuana (medical cannabis) or any prescription medication intended to increase appetite or treat unintentional weight loss
  • have a baseline stair climb time >or=30 seconds (mean of two stair climbs)
  • Have active cancer, other than NSCLC, or non-melanoma carcinoma of the skin, within the previous two years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01355484

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United States, Alabama
GTx Investigative Site
Birmingham, Alabama, United States, 35211
United States, California
GTx Investigative Site
Long Beach, California, United States, 90813
United States, Florida
GTx Investigative Site
Aventura, Florida, United States, 33180
GTx Investigative Site
Miami, Florida, United States, 33133
GTx Investigative Site
Orange City, Florida, United States, 32763
GTx Investigative Site
Tampa, Florida, United States, 33612
United States, Illinois
GTx Investigative Site
Decatur, Illinois, United States, 62526
GTx Investigative Site
Peoria, Illinois, United States, 61615
GTx Investigative Site
Skokie, Illinois, United States, 60076
United States, Indiana
GTx Investigative Site
Indianapolis, Indiana, United States, 46260
United States, Kentucky
GTx Investigative Site
Ashland, Kentucky, United States, 41101
United States, Massachusetts
GTx Investigative Site
Concord, Massachusetts, United States, 01742
United States, Michigan
GTx Investigative Site
St Clair Shores, Michigan, United States, 48081
United States, Mississippi
GTx Investigative Site
Tupelo, Mississippi, United States, 38801
United States, Montana
GTx Investigative Site
Great Falls, Montana, United States, 59405
United States, New York
GTx Investigative Site
Rochester, New York, United States, 14642
United States, North Carolina
GTx Investigative Site
Burlington, North Carolina, United States, 27215
GTx Investigative Site
Flat Rock, North Carolina, United States, 28731
GTx Investigative Site
Wilmington, North Carolina, United States, 28401
GTx Investigative Site
Winston Salem, North Carolina, United States, 27103
United States, Ohio
GTx Investigative Site
Canfield, Ohio, United States, 44406
Gabrail Cancer Center
Canton, Ohio, United States, 44718
GTx Investigative Site
Sandusky, Ohio, United States, 44870
United States, Oregon
GTx Investigative Site
Portland, Oregon, United States, 97213
United States, Pennsylvania
GTx Investigative Site
Lancaster, Pennsylvania, United States, 17604
United States, South Carolina
GTx Investigative Site
Spartanburg, South Carolina, United States, 29303
United States, Texas
GTx Investigative Site
Round Rock, Texas, United States, 78665
Sponsors and Collaborators
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: GTx Identifier: NCT01355484    
Other Study ID Numbers: G300504
POWER1 ( Other Identifier: GTx )
First Posted: May 18, 2011    Key Record Dates
Results First Posted: March 3, 2016
Last Update Posted: March 3, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Muscular Atrophy
Wasting Syndrome
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Pathological Conditions, Anatomical