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

Completed · Phase 2 · Has a placebo group

Conditions studied: Cachexia

In brief

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.

Key facts

Study ID

NCT00467844

Run by

GTx

People needed

159

Starts

2007-05-01

Expected to finish

2008-09-01

Last updated by the study team

2014-07-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• Alaska Cancer Research and Education Center — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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