Double-Blind, Placebo-Controlled, Dose-Finding Study of the Effect of GTx-024 on Muscle Wasting (Cachexia) in Patients With Cancer
N/A
N/A
Both
Cachexia
Trial Information
Double-Blind, Placebo-Controlled, Dose-Finding Study of the Effect of GTx-024 on Muscle Wasting (Cachexia) in Patients With Cancer
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 energy expenditure, but a decrease in voluntary energy expenditure that
ultimately results clinically in cachexia and its symptoms of lethargy, fatigue, weakness
and general malaise (Kotler DP. Cachexia. Ann Intern Med. 2000; 133:622-634).
The prevalence of cachexia increases from 50 percent at presentation to more than 80 percent
before death from malignancy. In over 20 percent of cancer patients, cachexia is the cause
of death (Bruera E. Anorexia, cachexia and nutrition. Br Med J 1997;315:1219-1222). Cancer
cachexia leads to shorter survival, decreased response rates and increased toxicity to
chemotherapy, weakness, and an overall decreased quality of life (DeWys et al. Prognostic
effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology
Group. Am J Med. 1980 Oct;69(4):491-7). The purpose of this study is to assess the efficacy
of GTx-024 on total body lean mass. Secondary endpoints include but are not limited to
assessment of GTx-024 on muscle function, total body weight and total body fat mass.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Outcome Measure:
The Efficacy of GTx-024 on Total Body Lean Mass.
Outcome Description:
Change in total body lean mass as measured by dual energy x-ray absorptiometry (DEXA)from baseline to 4 months.
Outcome Time Frame:
Baseline to Four Months
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
G200502
NCT ID:
NCT00467844
Start Date:
May 2007
Completion Date:
September 2008
Related Keywords:
- Cachexia
- Cachexia
- Muscle Wasting
- Non-Small Cell Lung Cancer
- Colorectal Cancer
- Non-Hodgkin's Lymphoma
- Stage 3 or 4 Breast Cancer
- Chronis Lymphocytic Leukemia
- Cachexia
- Muscular Atrophy
Name | Location |
|---|---|
| Hematology Oncology Associates | Atlantis, Florida 33462 |
| Penrose Cancer Center | Colorado Springs, Colorado 80933 |
| Highlands Oncology Group | Springdale, Arkansas 72764 |
| Kentuckiana Cancer Institute | Louisville, Kentucky 40202 |
| West Clinic | Memphis, Tennessee 38117 |
| Innovative Medical Research of South Florida, Inc. | Miami, Florida 33138 |
| Augusta Oncology Associates | Augusta, Georgia 30901 |
| Urological Associates Of Lancaster | Lancaster, Pennsylvania 17604-3200 |
| Gabrail Cancer Center | Canton, Ohio 44718 |
| Pacific Coast Hematology/Oncology Medical Group, Inc. | Fountain Valley, California 92708 |
| Florida Medical Clinic, PA | Zephyrhills, Florida 33542 |
| Dallas Oncology Consultants | Dallas, Texas 75201 |
| Center for Cancer & Blood Disorders | Bethesda, Maryland 20817 |
| Cancer Care of Western North Carolina | Asheville, North Carolina 28801 |
| Alaska Cancer Research and Education Center | Anchorage, Alaska 99508 |
| Cancer Center of Kansas | Wichita, Kansas 67214 |
| Hanover Medical Specialists | Wilmington, North Carolina 28401 |
| Gainesville Hematology Oncology Associates | Gainesville, Florida 32605 |
| Osler Medical | West Melbourne, Florida 32901 |
| Desert Hematology Oncology Medical Group | Rancho Mirage, California 92270 |
| Compassionate Cancer Care Medical Group | Corona, California 92882 |
| Consultants in Medical Oncology and Hematology | Drexel Hill, Pennsylvania 19026 |
| The West Clinic | Corinth, Mississippi 38834 |
| Signal Point Clinical Research Center, LLC | Middletown, Ohio 45042 |
| Compassionate Cancer Care | Corona, California 92882 |
| Dorcy Cancer Center | Pueblo, Colorado 81004 |
| Hartford Hospital Cancer Clinical Research Office | Hartford, Connecticut 06102 |
| Medical Oncology & Hematology, PC | Waterbury, Connecticut 06708 |
| Horizon Institute for Clinical Research | Hollywood, Florida 33021 |
| The Radiation Oncology Group | Lake Worth, Florida 33461 |
| Watson Clinic LLP, Center for Cancer Care & Research | Lakeland, Florida 33805 |
| Dublin Hematology and Oncology | Dublin, Georgia 31021 |
| Johns Hopkins University Clinical Trial Unit | Baltimore, Maryland 21287 |
| The Center for Clinical Research WA County Hospital | Hagerstown, Maryland 21740 |
| Newland Medical Center | Southfield, Michigan 48075 |
| West Clinic | Corinth, Mississippi 38834 |
| Hematology & Oncology Associates at Bridgeport | Tupelo, Mississippi 38801 |
| Heartland Hematology-Oncology Associates | Kansas City, Missouri 64118 |
| Great Falls Clinic, LLP - Clinic Cancer Care | Great Falls, Montana 59405 |
| Donald H. Berdeaux, MD, FACP, PC | Great Falls, Montana 59405 |
| Creighton University Hematology/Oncology Clinic | Omaha, Nebraska 68131 |
| Four Seasons Hospice & Palliative Care | Flat Rock, North Carolina 28731 |
| Hematology Oncology Consultants | Worthington, Ohio 43235 |
| Berks Hematology-Oncology Associates | West Reading, Pennsylvania 19611 |
| Charleston Hematology Oncology Associates | Charleston, South Carolina 29403 |
| Providence Everett Medical Center, Cancer Research Department | Everett, Washington 98201 |
