Know Cancer

forgot password

Double-Blind, Placebo-Controlled, Dose-Finding Study of the Effect of GTx-024 on Muscle Wasting (Cachexia) in Patients With Cancer

Phase 2
Not Enrolling

Thank you

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

- 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 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

- Currently taking megestrol acetate (MEGACE®), dronabinol (MARINOL®), or any
prescription medication intended to increase appetite or treat unintentional weight

Type of Study:


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:



United States: Food and Drug Administration

Study ID:




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



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