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.
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.
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
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There are 47 Locations for this study
Anchorage Alaska, 99508, United States
Fayetteville Arkansas, 72703, United States
Corona California, 92882, United States
Fountain Valley California, 92708, United States
Fountain Valley California, 92708, United States
Rancho Mirage California, 92270, United States
Riverside California, 92501, United States
Colorado Springs Colorado, 80907, United States
Pueblo Colorado, 81004, United States
Hartford Connecticut, 06102, United States
Waterbury Connecticut, 06708, United States
Gainesville Florida, 32605, United States
Hollywood Florida, 33021, United States
Lake Worth Florida, 33461, United States
Lake Worth Florida, 33461, United States
Lakeland Florida, 33805, United States
Melbourne Florida, 32901, United States
Miami Florida, 33179, United States
Zephyrhills Florida, 33542, United States
Augusta Georgia, 30901, United States
Dublin Georgia, 31021, United States
Wichita Kansas, 67214, United States
Louisville Kentucky, 40202, United States
Baltimore Maryland, 21287, United States
Bethesda Maryland, 20817, United States
Hagerstown Maryland, 21740, United States
Southfield Michigan, 48075, United States
Corinth Mississippi, 38834, United States
Corinth Mississippi, 38834, United States
Southaven Mississippi, 38671, United States
Southaven Mississippi, 38671, United States
Tupelo Mississippi, 38801, United States
Kansas City Missouri, 64118, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Omaha Nebraska, 68131, United States
Ashville North Carolina, 28801, United States
Flat Rock North Carolina, 28731, United States
Wilmington North Carolina, 28401, United States
Canton Ohio, 44718, United States
Middletown Ohio, 45042, United States
Worthington Ohio, 43235, United States
Drexel Hill Pennsylvania, 19026, United States
Lancaster Pennsylvania, 17604, United States
West Reading Pennsylvania, 19611, United States
Charleston South Carolina, 29403, United States
Memphis Tennessee, 38104, United States
Memphis Tennessee, 38120, United States
Dallas Texas, 75237, United States
Everett Washington, 98201, United States
Edmonton Alberta, T6G 1, Canada
Toronto Ontario, M5G 2, Canada
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