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

February 4, 2016 updated by: GTx

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
321

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 84
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.
Day 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GTx

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 3, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • G300504
  • POWER1 (Other Identifier: GTx)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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