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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GTx

ClinicalTrials.gov Identifier:

NCT00467844

First received: April 30, 2007

Last updated: February 26, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	April 30, 2007
Last Updated Date	February 26, 2013
Start Date ^ICMJE	May 2007
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 26, 2013)	The Efficacy of GTx-024 on Total Body Lean Mass. [ Time Frame: Baseline to Four Months ] [ Designated as safety issue: No ] Change in total body lean mass as measured by dual energy x-ray absorptiometry (DEXA)from baseline to 4 months.
Original Primary Outcome Measures ^ICMJE (submitted: April 30, 2007)	To assess the efficacy of GTx-024 on total body lean mass. [ Time Frame: Six Months ]
Change History	Complete list of historical versions of study NCT00467844 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 18, 2013)	To Assess the Efficacy of GTx-024 on Muscle Function (Performance) as Measured by Stair Climb. [ Time Frame: Four Months ] [ Designated as safety issue: No ] 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 Measures ^ICMJE (submitted: April 30, 2007)	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 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of GTx-024 on Muscle Wasting (Cachexia) Cancer.
Official Title ^ICMJE	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 Description	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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care
Condition ^ICMJE	Cachexia
Intervention ^ICMJE	Drug: GTx-024 1 mg GTx 024 Drug: GTx-024 3 mg GTx-024 Drug: Placebo Matching Placebo
Study Arm (s)	Experimental: 1 1 mg GTx-024 Intervention: Drug: GTx-024 Experimental: 2 3 mg GTx-024 Intervention: Drug: GTx-024 Placebo Comparator: 3 Placebo Intervention: Drug: Placebo
Publications *	Dobs AS, Boccia RV, Croot CC, Gabrail NY, Dalton JT, Hancock ML, Johnston MA, Steiner MS. Effects of enobosarm on muscle wasting and physical function in patients with cancer: a double-blind, randomised controlled phase 2 trial. Lancet Oncol. 2013 Apr;14(4):335-45. doi: 10.1016/S1470-2045(13)70055-X. Epub 2013 Mar 14.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	159
Completion Date	September 2008
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT Number ^ICMJE	NCT00467844
Other Study ID Numbers ^ICMJE	G200502
Has Data Monitoring Committee	No
Responsible Party	GTx
Study Sponsor ^ICMJE	GTx
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	GTx
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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