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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

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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



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