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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

Tracking Information
First Submitted Date  ICMJE May 12, 2011
First Posted Date  ICMJE May 18, 2011
Results First Submitted Date  ICMJE February 4, 2016
Results First Posted Date  ICMJE March 3, 2016
Last Update Posted Date March 3, 2016
Study Start Date  ICMJE July 2011
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2016)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 17, 2011)
  • Improved Physical function [ Time Frame: Day 84 ]
    Physical function will be assessed by stair climb power at Day 84. The percentage of change from baseline will be computed to determine if a subject is a physical function responder.
  • Increased Lean body mass [ Time Frame: Day 84 ]
    At Day 84 a repeat Whole Body Composition Dexa Scan will be done and compared to the baseline Dexa.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase III Study of the Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC)
Official Title  ICMJE 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
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".
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Muscle Wasting
  • Non Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: GTx-024
    subjects will be randomized to receive GTx-024 for the full duration of the trial.
  • Drug: placebo
    subject will receive placebo for the duration of the trial
Study Arms  ICMJE
  • Experimental: GTx-024
    subject will receive GTx-024 treatment for the duration of the trial
    Intervention: Drug: GTx-024
  • Placebo Comparator: Placebo
    subject will receive placebo for the duration of the trial
    Intervention: Drug: placebo
Publications * Crawford J, Prado CM, Johnston MA, Gralla RJ, Taylor RP, Hancock ML, Dalton JT. Study Design and Rationale for the Phase 3 Clinical Development Program of Enobosarm, a Selective Androgen Receptor Modulator, for the Prevention and Treatment of Muscle Wasting in Cancer Patients (POWER Trials). Curr Oncol Rep. 2016 Jun;18(6):37. doi: 10.1007/s11912-016-0522-0. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2015)
321
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2011)
300
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01355484
Other Study ID Numbers  ICMJE G300504
POWER1 ( Other Identifier: GTx )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GTx
Study Sponsor  ICMJE GTx
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account GTx
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP