Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
159 participants
INTERVENTIONAL
2007-05-31
2008-09-30
Brief Summary
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Detailed Description
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The prevalence of cachexia increases from 50 percent at presentation to more than 80 percent before death from malignancy. In over 20 percent of cancer patients, cachexia is the cause of death (Bruera E. Anorexia, cachexia and nutrition. Br Med J 1997;315:1219-1222). Cancer cachexia leads to shorter survival, decreased response rates and increased toxicity to chemotherapy, weakness, and an overall decreased quality of life (DeWys et al. Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group. Am J Med. 1980 Oct;69(4):491-7). The purpose of this study is to assess the efficacy of GTx-024 on total body lean mass. Secondary endpoints include but are not limited to assessment of GTx-024 on muscle function, total body weight and total body fat mass.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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1
1 mg GTx-024
GTx-024
1 mg GTx 024
2
3 mg GTx-024
GTx-024
3 mg GTx-024
3
Placebo
Placebo
Matching Placebo
Interventions
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GTx-024
1 mg GTx 024
GTx-024
3 mg GTx-024
Placebo
Matching Placebo
Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* 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
ALL
No
Sponsors
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GTx
INDUSTRY
Responsible Party
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Locations
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Newland Medical Center
Southfield, Michigan, United States
The West Clinic
Corinth, Mississippi, United States
West Clinic
Corinth, Mississippi, United States
The West Clinic
Southaven, Mississippi, United States
West Clinic
Southaven, Mississippi, United States
Hematology & Oncology Associates at Bridgeport
Tupelo, Mississippi, United States
Heartland Hematology-Oncology Associates
Kansas City, Missouri, United States
Donald H. Berdeaux, MD, FACP, PC
Great Falls, Montana, United States
Great Falls Clinic, LLP - Clinic Cancer Care
Great Falls, Montana, United States
Alaska Cancer Research and Education Center
Anchorage, Alaska, United States
Highlands Oncology Group
Fayetteville, Arkansas, United States
Compassionate Cancer Care
Corona, California, United States
Compassionate Cancer Care Medical Group
Fountain Valley, California, United States
Pacific Coast Hematology/Oncology Medical Group, Inc.
Fountain Valley, California, United States
Desert Hematology Oncology Medical Group
Rancho Mirage, California, United States
Compassionate Cancer Care
Riverside, California, United States
Penrose Cancer Center
Colorado Springs, Colorado, United States
Dorcy Cancer Center
Pueblo, Colorado, United States
Hartford Hospital Cancer Clinical Research Office
Hartford, Connecticut, United States
Medical Oncology & Hematology, PC
Waterbury, Connecticut, United States
Gainesville Hematology Oncology Associates
Gainesville, Florida, United States
Horizon Institute for Clinical Research
Hollywood, Florida, United States
Hematology Oncology Associates
Lake Worth, Florida, United States
The Radiation Oncology Group
Lake Worth, Florida, United States
Watson Clinic LLP, Center for Cancer Care & Research
Lakeland, Florida, United States
Osler Medical
Melbourne, Florida, United States
Innovative Medical Research of South Florida, Inc.
Miami, Florida, United States
Florida Medical Clinic, PA
Zephyrhills, Florida, United States
Augusta Oncology Associates
Augusta, Georgia, United States
Dublin Hematology and Oncology
Dublin, Georgia, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Kentuckiana Cancer Institute
Louisville, Kentucky, United States
Johns Hopkins University Clinical Trial Unit
Baltimore, Maryland, United States
Center for Cancer & Blood Disorders
Bethesda, Maryland, United States
The Center for Clinical Research WA County Hospital
Hagerstown, Maryland, United States
Creighton University Hematology/Oncology Clinic
Omaha, Nebraska, United States
Cancer Care of Western North Carolina
Ashville, North Carolina, United States
Four Seasons Hospice & Palliative Care
Flat Rock, North Carolina, United States
Hanover Medical Specialists
Wilmington, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
Signal Point Clinical Research Center, LLC
Middletown, Ohio, United States
Hematology Oncology Consultants
Worthington, Ohio, United States
Consultants in Medical Oncology and Hematology
Drexel Hill, Pennsylvania, United States
Urological Associates of Lancaster
Lancaster, Pennsylvania, United States
Berks Hematology-Oncology Associates
West Reading, Pennsylvania, United States
Charleston Hematology Oncology Associates
Charleston, South Carolina, United States
West Clinic
Memphis, Tennessee, United States
West Clinic
Memphis, Tennessee, United States
Dallas Oncology Consultants
Dallas, Texas, United States
Providence Everett Medical Center, Cancer Research Department
Everett, Washington, United States
University of Alberta Cross Cancer Institute
Edmonton, Alberta, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Countries
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References
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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.
Other Identifiers
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G200502
Identifier Type: -
Identifier Source: org_study_id
NCT00832104
Identifier Type: -
Identifier Source: nct_alias
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