Phase 2
Completed N=159
Study of GTx-024 on Muscle Wasting (Cachexia) Cancer.
Source: ClinicalTrials.gov NCT00467844 ↗Enrolled (actual)
159
Serious AEs
28.9%
Results posted
Feb 2013
Primary outcomePrimary: The Efficacy of GTx-024 on Total Body Lean Mass. — 1.55; 0.98; 0.02 kg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Efficacy of GTx-024 on Total Body Lean Mass. |
1.55; 0.98; 0.02 | — |
| SECONDARY To Assess the Efficacy of GTx-024 on Muscle Function (Performance) as Measured by Stair Climb. |
19.93; 12.84; 11.34 | — |
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
Data sourced from ClinicalTrials.gov (NCT00467844). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.