Study of GTx-024 on Muscle Wasting (Cachexia) Cancer.
Cachexia
About this trial
This is an interventional supportive care trial for Cachexia focused on measuring Cachexia, Muscle Wasting, Non-Small Cell Lung Cancer, Colorectal Cancer, Non-Hodgkin's Lymphoma, Stage 3 or 4 Breast Cancer, Chronis Lymphocytic Leukemia
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
Sites / Locations
- Alaska Cancer Research and Education Center
- Highlands Oncology Group
- Compassionate Cancer Care
- Compassionate Cancer Care Medical Group
- Pacific Coast Hematology/Oncology Medical Group, Inc.
- Desert Hematology Oncology Medical Group
- Compassionate Cancer Care
- Penrose Cancer Center
- Dorcy Cancer Center
- Hartford Hospital Cancer Clinical Research Office
- Medical Oncology & Hematology, PC
- Gainesville Hematology Oncology Associates
- Horizon Institute for Clinical Research
- Hematology Oncology Associates
- The Radiation Oncology Group
- Watson Clinic LLP, Center for Cancer Care & Research
- Osler Medical
- Innovative Medical Research of South Florida, Inc.
- Florida Medical Clinic, PA
- Augusta Oncology Associates
- Dublin Hematology and Oncology
- Cancer Center of Kansas
- Kentuckiana Cancer Institute
- Johns Hopkins University Clinical Trial Unit
- Center for Cancer & Blood Disorders
- The Center for Clinical Research WA County Hospital
- Newland Medical Center
- The West Clinic
- West Clinic
- The West Clinic
- West Clinic
- Hematology & Oncology Associates at Bridgeport
- Heartland Hematology-Oncology Associates
- Donald H. Berdeaux, MD, FACP, PC
- Great Falls Clinic, LLP - Clinic Cancer Care
- Creighton University Hematology/Oncology Clinic
- Cancer Care of Western North Carolina
- Four Seasons Hospice & Palliative Care
- Hanover Medical Specialists
- Gabrail Cancer Center
- Signal Point Clinical Research Center, LLC
- Hematology Oncology Consultants
- Consultants in Medical Oncology and Hematology
- Urological Associates of Lancaster
- Berks Hematology-Oncology Associates
- Charleston Hematology Oncology Associates
- West Clinic
- West Clinic
- Dallas Oncology Consultants
- Providence Everett Medical Center, Cancer Research Department
- University of Alberta Cross Cancer Institute
- Princess Margaret Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
1
2
3
1 mg GTx-024
3 mg GTx-024
Placebo