Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00467844
Status:
COMPLETED
Last Update Posted:
2014-07-11
First Post:
2007-04-30
Brief Title:
Study of GTx-024 on Muscle Wasting Cachexia Cancer
Sponsor:
GTx
Organization:
GTx
Study Overview
Official Title:
Double-Blind Placebo-Controlled Dose-Finding Study of the Effect of GTx-024 on Muscle Wasting Cachexia in Patients With Cancer
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
Cancer cachexia is characterized by a hypermetabolic state that leads to catabolism that is responsible for reductions in lean massThese 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 133622-634
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 19973151219-1222 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 Oct694491-7 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
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 19973151219-1222 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 Oct694491-7 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None