Status:
COMPLETED
Study of GTx-024 on Muscle Wasting (Cachexia) Cancer.
Lead Sponsor:
GTx
Conditions:
Cachexia
Eligibility:
All Genders
Phase:
PHASE2
Brief 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.
Detailed 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 ener...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
159 Patients enrolled
Trial Details
Trial ID
NCT00467844
Start Date
May 1 2007
End Date
September 1 2008
Last Update
July 11 2014
Active Locations (52)
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1
Alaska Cancer Research and Education Center
Anchorage, Alaska, United States, 99508
2
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
3
Compassionate Cancer Care
Corona, California, United States, 92882
4
Compassionate Cancer Care Medical Group
Fountain Valley, California, United States, 92708