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

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

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".

Study Overview

• Status: Completed
• Conditions: Non Small Cell Lung Cancer; Muscle Wasting
• Intervention / Treatment: Drug: GTx-024; Drug: placebo

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: Interventional
• Enrollment (Actual): 321
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35211
      • GTx Investigative Site
  • California
    • Long Beach, California, United States, 90813
      • GTx Investigative Site
  • Florida
    • 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
      • GTx Investigative Site
  • Illinois
    • Decatur, Illinois, United States, 62526
      • GTx Investigative Site
    • Peoria, Illinois, United States, 61615
      • GTx Investigative Site
    • Skokie, Illinois, United States, 60076
      • GTx Investigative Site
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • GTx Investigative Site
  • Kentucky
    • Ashland, Kentucky, United States, 41101
      • GTx Investigative Site
  • Massachusetts
    • Concord, Massachusetts, United States, 01742
      • GTx Investigative Site
  • Michigan
    • St Clair Shores, Michigan, United States, 48081
      • GTx Investigative Site
  • Mississippi
    • Tupelo, Mississippi, United States, 38801
      • GTx Investigative Site
  • Montana
    • Great Falls, Montana, United States, 59405
      • GTx Investigative Site
  • New York
    • Rochester, New York, United States, 14642
      • GTx Investigative Site
  • North Carolina
    • 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
      • GTx Investigative Site
  • Ohio
    • Canfield, Ohio, United States, 44406
      • GTx Investigative Site
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center
    • Sandusky, Ohio, United States, 44870
      • GTx Investigative Site
  • Oregon
    • Portland, Oregon, United States, 97213
      • GTx Investigative Site
  • Pennsylvania
    • Lancaster, Pennsylvania, United States, 17604
      • GTx Investigative Site
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • GTx Investigative Site
  • Texas
    • Round Rock, Texas, United States, 78665
      • GTx Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 26 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical Function	Measure is the percentage of subjects at day 84 with stair climb power change >=10% from their baseline value.	Day 84
Lean Body Mass	Measure is the percentage of subjects at day 84 with lean body mass change >=0% from their baseline value.	Day 84

Collaborators and Investigators

• Sponsor: GTx

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: May 12, 2011
• First Submitted That Met QC Criteria: May 17, 2011
• First Posted (Estimate): May 18, 2011

Study Record Updates

• Last Update Posted (Estimate): March 3, 2016
• Last Update Submitted That Met QC Criteria: February 4, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Neurologic Manifestations; Nutrition Disorders; Body Weight; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Body Weight Changes; Atrophy; Emaciation; Weight Loss; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Muscular Atrophy; Wasting Syndrome; Cachexia
• Other Study ID Numbers: G300504; POWER1 (Other Identifier: GTx)