Study of GTx-024 on Muscle Wasting (Cachexia) Cancer.
Double-Blind, Placebo-Controlled, Dose-Finding Study of the Effect of GTx-024 on Muscle Wasting (Cachexia) in Patients With Cancer
1 other identifier
interventional
159
2 countries
52
Brief Summary
The purpose of this study is to assess if Gtx-024 is effective in increasing lean body mass in subjects with muscle wasting related to cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2007
Shorter than P25 for phase_2
52 active sites
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
April 30, 2007
CompletedFirst Posted
Study publicly available on registry
May 1, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedResults Posted
Study results publicly available
February 21, 2013
CompletedJuly 11, 2014
June 1, 2014
1.3 years
April 30, 2007
January 18, 2013
June 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Efficacy of GTx-024 on Total Body Lean Mass.
Change in total body lean mass as measured by dual energy x-ray absorptiometry (DEXA)from baseline to 4 months.
Baseline to Four Months
Secondary Outcomes (1)
To Assess the Efficacy of GTx-024 on Muscle Function (Performance) as Measured by Stair Climb.
Four Months
Study Arms (3)
1
EXPERIMENTAL1 mg GTx-024
2
EXPERIMENTAL3 mg GTx-024
3
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- To be eligible for participation in this study, subjects must meet all of the following criteria:
- have been diagnosed with Stage 2, 3 or 4 non-small cell lung cancer or Stage 2, 3 or 4 colorectal cancer or non-hodgkin's lymphoma or chronic lymphocytic leukemia or Stage 3 or 4 breast cancer.
- be prior to initiation of or between cycles of chemotherapy.
- have experienced greater than or equal to 2% weight loss from the highest patient reported weight in the 6 months prior to screening for Protocol G200502 (Wt = body weight)
- % weight loss = (Wt at screening - highest Wt in last 6 months) / highest Wt in last 6 months x 100%
- If surgery is part of the cancer treatment, screening for this study should be conducted at least 2 weeks (14 days) after surgery.
- have a life expectancy of \>6 months
- FEMALES - be clinically confirmed as postmenopausal
- MALES - over 45 years of age
- ECOG score ≤1
You may not qualify if:
- Subjects with any of the following will NOT be eligible for enrollment in this study:
- history of active/uncontrolled congestive heart failure, chronic hepatitis, hepatic cirrhosis, or HIV infection
- Cardiovascular: No uncontrolled hypertension
- Positive screen for Hepatitis B consisting of HBsAg (Hepatitis B Surface Antigen), anti-HCV (Hepatitis C Antibody), hepatitis A antibody IgM, or HIV
- Currently taking testosterone, OXANDRIN® (oxandrolone), testosterone-like agents (such as DHEA, androstenedione, and other androgenic compounds, including herbals), or antiandrogens (Please note that previous therapy with testosterone and testosterone-like agents is acceptable with a 30 day wash-out. However, if the previous testosterone therapy was a long-term depot, within the past 6 months, the site should call the medical monitor for this study to determine appropriate washout period.)
- Currently taking megestrol acetate (MEGACE®), dronabinol (MARINOL®), or any prescription medication intended to increase appetite or treat unintentional weight loss
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GTxlead
Study Sites (52)
Alaska Cancer Research and Education Center
Anchorage, Alaska, 99508, United States
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
Compassionate Cancer Care
Corona, California, 92882, United States
Compassionate Cancer Care Medical Group
Fountain Valley, California, 92708, United States
Pacific Coast Hematology/Oncology Medical Group, Inc.
Fountain Valley, California, 92708, United States
Desert Hematology Oncology Medical Group
Rancho Mirage, California, 92270, United States
Compassionate Cancer Care
Riverside, California, 92501, United States
Penrose Cancer Center
Colorado Springs, Colorado, 80907, United States
Dorcy Cancer Center
Pueblo, Colorado, 81004, United States
Hartford Hospital Cancer Clinical Research Office
Hartford, Connecticut, 06102, United States
Medical Oncology & Hematology, PC
Waterbury, Connecticut, 06708, United States
Gainesville Hematology Oncology Associates
Gainesville, Florida, 32605, United States
Horizon Institute for Clinical Research
Hollywood, Florida, 33021, United States
Hematology Oncology Associates
Lake Worth, Florida, 33461, United States
The Radiation Oncology Group
Lake Worth, Florida, 33461, United States
Watson Clinic LLP, Center for Cancer Care & Research
Lakeland, Florida, 33805, United States
Osler Medical
Melbourne, Florida, 32901, United States
Innovative Medical Research of South Florida, Inc.
Miami, Florida, 33179, United States
Florida Medical Clinic, PA
Zephyrhills, Florida, 33542, United States
Augusta Oncology Associates
Augusta, Georgia, 30901, United States
Dublin Hematology and Oncology
Dublin, Georgia, 31021, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
Kentuckiana Cancer Institute
Louisville, Kentucky, 40202, United States
Johns Hopkins University Clinical Trial Unit
Baltimore, Maryland, 21287, United States
Center for Cancer & Blood Disorders
Bethesda, Maryland, 20817, United States
The Center for Clinical Research WA County Hospital
Hagerstown, Maryland, 21740, United States
Newland Medical Center
Southfield, Michigan, 48075, United States
The West Clinic
Corinth, Mississippi, 38834, United States
West Clinic
Corinth, Mississippi, 38834, United States
The West Clinic
Southaven, Mississippi, 38671, United States
West Clinic
Southaven, Mississippi, 38671, United States
Hematology & Oncology Associates at Bridgeport
Tupelo, Mississippi, 38801, United States
Heartland Hematology-Oncology Associates
Kansas City, Missouri, 64118, United States
Donald H. Berdeaux, MD, FACP, PC
Great Falls, Montana, 59405, United States
Great Falls Clinic, LLP - Clinic Cancer Care
Great Falls, Montana, 59405, United States
Creighton University Hematology/Oncology Clinic
Omaha, Nebraska, 68131, United States
Cancer Care of Western North Carolina
Ashville, North Carolina, 28801, United States
Four Seasons Hospice & Palliative Care
Flat Rock, North Carolina, 28731, United States
Hanover Medical Specialists
Wilmington, North Carolina, 28401, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Signal Point Clinical Research Center, LLC
Middletown, Ohio, 45042, United States
Hematology Oncology Consultants
Worthington, Ohio, 43235, United States
Consultants in Medical Oncology and Hematology
Drexel Hill, Pennsylvania, 19026, United States
Urological Associates of Lancaster
Lancaster, Pennsylvania, 17604, United States
Berks Hematology-Oncology Associates
West Reading, Pennsylvania, 19611, United States
Charleston Hematology Oncology Associates
Charleston, South Carolina, 29403, United States
West Clinic
Memphis, Tennessee, 38104, United States
West Clinic
Memphis, Tennessee, 38120, United States
Dallas Oncology Consultants
Dallas, Texas, 75237, United States
Providence Everett Medical Center, Cancer Research Department
Everett, Washington, 98201, United States
University of Alberta Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
Related Publications (1)
Dobs AS, Boccia RV, Croot CC, Gabrail NY, Dalton JT, Hancock ML, Johnston MA, Steiner MS. Effects of enobosarm on muscle wasting and physical function in patients with cancer: a double-blind, randomised controlled phase 2 trial. Lancet Oncol. 2013 Apr;14(4):335-45. doi: 10.1016/S1470-2045(13)70055-X. Epub 2013 Mar 14.
PMID: 23499390DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director, Clinical Operations
- Organization
- GTx Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2007
First Posted
May 1, 2007
Study Start
May 1, 2007
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
July 11, 2014
Results First Posted
February 21, 2013
Record last verified: 2014-06