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Muscle WastingPhase 3NCT01355497

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

A Phase 3 study testing GTx-024 in people with Muscle Wasting and Non-Small Cell Lung Cancer, run by GTx at 30 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Muscle Wasting, Non-Small Cell Lung Cancer
What is being tested?
GTx-024
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
330 participants
Where
30 sitesUnited States
Study dates
Jul 2011to Jun 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

United States30 sites

  • GTx Investigative Site

    Ashland, Kentucky, 41101

  • GTx Investigative Site

    Birmingham, Alabama, 35211

  • GTx Investigative Site

    Burlington, North Carolina, 27215

  • GTx Investigative Site

    Canfield, Ohio, 44406

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • GTx Investigative Site

    Concord, Massachusetts, 01742

  • GTx Investigative Site

    Decatur, Illinois, 62526

  • GTx Investigator

    Flat Rock, North Carolina, 28731

  • GTx Investigative Site

    Goshen, Indiana, 46526

  • GTx Investigative Site

    Great Falls, Montana, 59405

  • GTx Investigative Site

    Indianapolis, Indiana, 46260

  • GTx Investigative Site

    La Jolla, California, 92093

  • GTx Investigative Site

    Lancaster, Pennsylvania, 17604

  • GTx Investigative Site

    Long Beach, California, 90813

  • GTx Investigative Site

    Miami, Florida, 33133

  • GTx Investigative Site

    Nashville, Tennessee, 37203

  • GTx Investigative Site

    Orange City, Florida, 32763

  • GTx Investigative Site

    Peoria, Illinois, 61615

  • GTx Investigative Site

    Portland, Oregon, 97213

  • GTx Investigative Site

    Rochester, New York, 14642

  • GTx Investigative Site

    Round Rock, Texas, 78665

  • GTx Investigative Site

    Saint Clair Shores, Michigan, 48081

  • GTx Investigative Site

    Sandusky, Ohio, 44870

  • GTx Investigative Site

    Scottsdale, Arizona, 85255

  • GTx Investigative Site

    Skokie, Illinois, 60076

  • GTx Investigative Site

    Spartanburg, South Carolina, 29303

  • GTx Investigative Site

    Tampa, Florida, 33612

  • GTx Investigative Site

    Tupelo, Mississippi, 38801

  • GTx Investigative Site

    Wilmington, North Carolina, 28401

  • GTx Investigative Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: 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 Non-Taxane Chemotherapy

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.

Read the 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.

Being tested
GTx-024, placebo
Medical subject headings
Muscular Atrophy, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GTx-024Drug

    Also called enobosarm, ostarine

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

  • placeboDrug

    subject will receive matching placebo for the duration of the trial

Study groups in NCT01355497
Study groupRoleWhat they receive
GTx-024 3mg once dailyExperimentalsubjects will be randomized to receive GTx-024 3mg sofgel capsule once daily for the duration of the trial
Receives: Drug: GTx-024
placeboPlacebo comparatorsubjects will be randomized to receive matching placebo once daily for the duration of the trial
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Physical Function

    Measure is the percentage of subjects at day 84 with stair climb power change >=10% from their baseline value.

    Measured: Day 84

  2. Lean Body Mass

    Measure is the percentage of subjects at day 84 with lean body mass change >=0% from their baseline value.

    Measured: Day 84

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2011 (estimated)
  2. Study startJul 2011
  3. Primary completionMay 2013
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
330 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01355497
Sponsor's protocol ID
G300505
Other IDs
POWER2
Status last verified
Oct 2020
First submitted
12 May 2011
Last updated
9 Nov 2020
Data monitoring committee
Yes

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.

    PubMed 27138015

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GTx-024 in people with Muscle Wasting and Non-Small Cell Lung Cancer, run by GTx at 30 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical Function (time frame: Day 84). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01355497, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2020.

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