NCT01355484

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".

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2011

Typical duration for phase_3

Geographic Reach
1 country

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

March 3, 2016

Completed
Last Updated

March 3, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

May 12, 2011

Results QC Date

February 4, 2016

Last Update Submit

February 4, 2016

Conditions

Muscle WastingNon Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

GTx-024

EXPERIMENTAL

subject will receive GTx-024 treatment for the duration of the trial

Drug: GTx-024

Placebo

PLACEBO COMPARATOR

subject will receive placebo for the duration of the trial

Drug: placebo

Interventions

GTx-024DRUG

subjects will be randomized to receive GTx-024 for the full duration of the trial.

GTx-024
placeboDRUG

subject will receive placebo for the duration of the trial

Placebo

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

GTx Investigative Site

Birmingham, Alabama, 35211, United States

Location

GTx Investigative Site

Long Beach, California, 90813, United States

Location

GTx Investigative Site

Aventura, Florida, 33180, United States

Location

GTx Investigative Site

Miami, Florida, 33133, United States

Location

GTx Investigative Site

Orange City, Florida, 32763, United States

Location

GTx Investigative Site

Tampa, Florida, 33612, United States

Location

GTx Investigative Site

Decatur, Illinois, 62526, United States

Location

GTx Investigative Site

Peoria, Illinois, 61615, United States

Location

GTx Investigative Site

Skokie, Illinois, 60076, United States

Location

GTx Investigative Site

Indianapolis, Indiana, 46260, United States

Location

GTx Investigative Site

Ashland, Kentucky, 41101, United States

Location

GTx Investigative Site

Concord, Massachusetts, 01742, United States

Location

GTx Investigative Site

Saint Clair Shores, Michigan, 48081, United States

Location

GTx Investigative Site

Tupelo, Mississippi, 38801, United States

Location

GTx Investigative Site

Great Falls, Montana, 59405, United States

Location

GTx Investigative Site

Rochester, New York, 14642, United States

Location

GTx Investigative Site

Burlington, North Carolina, 27215, United States

Location

GTx Investigative Site

Flat Rock, North Carolina, 28731, United States

Location

GTx Investigative Site

Wilmington, North Carolina, 28401, United States

Location

GTx Investigative Site

Winston-Salem, North Carolina, 27103, United States

Location

GTx Investigative Site

Canfield, Ohio, 44406, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

GTx Investigative Site

Sandusky, Ohio, 44870, United States

Location

GTx Investigative Site

Portland, Oregon, 97213, United States

Location

GTx Investigative Site

Lancaster, Pennsylvania, 17604, United States

Location

GTx Investigative Site

Spartanburg, South Carolina, 29303, United States

Location

GTx Investigative Site

Round Rock, Texas, 78665, United States

Location

Related Publications (1)

  • 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.

    PMID: 27138015DERIVED

MeSH Terms

Conditions

Muscular AtrophyCarcinoma, Non-Small-Cell Lung

Interventions

ostarine

Condition Hierarchy (Ancestors)

Neuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Senior Director, Clinical Operations
Organization
GTx Inc.
mdesordi@gtxinc.com
1-901-261-3795

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2011

First Posted

May 18, 2011

Study Start

July 1, 2011

Primary Completion

May 1, 2013

Study Completion

June 1, 2014

Last Updated

March 3, 2016

Results First Posted

March 3, 2016

Record last verified: 2016-02

Locations

US(27)