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

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GTx

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