Breast Cancer Clinical Trial

Study of GTx-024 on Muscle Wasting (Cachexia) Cancer.

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.

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Full Description

Cancer cachexia is characterized by a hypermetabolic state that leads to catabolism that is responsible for reductions in lean mass.These catabolic changes are accompanied by an increase in total energy expenditure, but a decrease in voluntary energy expenditure that ultimately results clinically in cachexia and its symptoms of lethargy, fatigue, weakness and general malaise (Kotler DP. Cachexia. Ann Intern Med. 2000; 133:622-634).

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

159

Study ID:

NCT00467844

Recruitment Status:

Completed

Sponsor:

GTx

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There are 47 Locations for this study

See Locations Near You

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 1, Canada
Princess Margaret Hospital
Toronto Ontario, M5G 2, Canada

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

159

Study ID:

NCT00467844

Recruitment Status:

Completed

Sponsor:


GTx

How clear is this clinincal trial information?

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