Clinical Trial: Study of GTx-024 on Muscle Wasting (Cachexia) Cancer.

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: GTx

Current Primary Outcome: The Efficacy of GTx-024 on Total Body Lean Mass. [ Time Frame: Baseline to Four Months ]

Change in total body lean mass as measured by dual energy x-ray absorptiometry (DEXA)from baseline to 4 months.


Original Primary Outcome: To Assess the Efficacy of GTx-024 on Total Body Lean Mass. [ Time Frame: Six Months ]

Current Secondary Outcome: To Assess the Efficacy of GTx-024 on Muscle Function (Performance) as Measured by Stair Climb. [ Time Frame: Four Months ]

Change in stair climb power from baseline to 4 months. Stair climb power is defined power (watts)=[9.8 m/sec**2]*[weight (kg)]*[height of 12 steps(meters)]/ [time (seconds) up the 12 steps].


Original Secondary Outcome: To assess the continued effect of GTx-024 on body weight and survival out to 48 weeks of dosing and to assess the safety and tolerability of GTx-024. [ Time Frame: One year ]

Information By: GTx

Dates:
Date Received: April 30, 2007
Date Started: May 2007
Date Completion:
Last Updated: June 26, 2014
Last Verified: June 2014