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

Tracking Information
First Submitted Date ICMJE	May 12, 2011
First Posted Date ICMJE	May 18, 2011
Results First Submitted Date	February 4, 2016
Results First Posted Date	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	Complete list of historical versions of study NCT01355484 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	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	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	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	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	Sexes Eligible for Study: All
Ages	30 Years and older (Adult, Senior)
Accepts Healthy Volunteers	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	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