Effect of GTx-024 on Muscle Wasting in Patients With Non-Small Cell Lung Cancer (NSCLC) on First Line Platinum

NCT ID: NCT01355497

Last Updated: 2020-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2014-06-30

Brief Summary

The purpose of this study is to determine if the investigational drug GTx-024 can help patients with non small cell lung cancer increase physical function and maintain or gain muscle.

Detailed Description

This is a randomized, double blind, placebo controlled, multicenter, multinational efficacy and safety study in subjects with non small cell lung cancer. 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 (LBM) and physical function.

Conditions

Muscle Wasting; Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

GTx-024 3mg once daily

subjects will be randomized to receive GTx-024 3mg sofgel capsule once daily for the duration of the trial

Group Type: EXPERIMENTAL

GTx-024

Intervention Type: DRUG

subjects will be randomized to receive GTx-024 3mg softgel for the duration of the trial.

placebo

subjects will be randomized to receive matching placebo once daily for the duration of the trial

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

subject will receive matching placebo for the duration of the trial

Interventions

GTx-024

subjects will be randomized to receive GTx-024 3mg softgel for the duration of the trial.

Intervention Type: DRUG

placebo

subject will receive matching placebo for the duration of the trial

Intervention Type: DRUG

Other Intervention Names

enobosarm, ostarine

Eligibility Criteria

Inclusion Criteria

• give voluntary, signed informed consent in accordance with institutional policies
• be non-obese as defined as body mass index (BMI)< or = 32 and weight < 300 pounds (< 136 kg)
• have been diagnosed with Stage III or IV NSCLC
• be prior to first line chemotherapy
• planned first line chemotherapy regimen is platinum plus gemcitabine only or platinum plus vinorelbine only or platinum plus pemetrexed 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
• 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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GTx

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

GTx Investigative Site

Birmingham, Alabama, United States

GTx Investigative Site

Scottsdale, Arizona, United States

GTx Investigative Site

La Jolla, California, United States

GTx Investigative Site

Long Beach, California, United States

GTx Investigative Site

Miami, Florida, United States

GTx Investigative Site

Orange City, Florida, United States

GTx Investigative Site

Tampa, Florida, United States

GTx Investigative Site

Decatur, Illinois, United States

GTx Investigative Site

Peoria, Illinois, United States

GTx Investigative Site

Skokie, Illinois, United States

GTx Investigative Site

Goshen, Indiana, United States

GTx Investigative Site

Indianapolis, Indiana, United States

GTx Investigative Site

Ashland, Kentucky, United States

GTx Investigative Site

Concord, Massachusetts, United States

GTx Investigative Site

Saint Clair Shores, Michigan, United States

GTx Investigative Site

Tupelo, Mississippi, United States

GTx Investigative Site

Great Falls, Montana, United States

GTx Investigative Site

Rochester, New York, United States

GTx Investigative Site

Burlington, North Carolina, United States

GTx Investigator

Flat Rock, North Carolina, United States

GTx Investigative Site

Wilmington, North Carolina, United States

GTx Investigative Site

Winston-Salem, North Carolina, United States

GTx Investigative Site

Canfield, Ohio, United States

Gabrail Cancer Center

Canton, Ohio, United States

GTx Investigative Site

Sandusky, Ohio, United States

GTx Investigative Site

Portland, Oregon, United States

GTx Investigative Site

Lancaster, Pennsylvania, United States

GTx Investigative Site

Spartanburg, South Carolina, United States

GTx Investigative Site

Nashville, Tennessee, United States

GTx Investigative Site

Round Rock, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 27138015 (View on PubMed)

Other Identifiers

POWER2

Identifier Type: OTHER

Identifier Source: secondary_id

G300505

Identifier Type: -

Identifier Source: org_study_id