Phase 2
N=159
Study of GTx-024 on Muscle Wasting (Cachexia) Cancer.
Cachexia
Bottom Line
View on ClinicalTrials.gov: NCT00467844 ↗Enrolled (actual)
159
Serious AEs
28.9%
Results posted
Feb 2013
Primary outcome: Primary: The Efficacy of GTx-024 on Total Body Lean Mass. — 1.55; 0.98; 0.02 kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- GTx-024 (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- GTx
- Primary completion
- Sep 2008
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 | — |
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.
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.