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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cachexia

Intervention / Treatment
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* Drug: GTx-024
* Drug: GTx-024
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>1 mg GTx-024 | Drug: GTx-024<br>* 1 mg GTx 024<br>|
| Experimental: 2<br>3 mg GTx-024 | Drug: GTx-024<br>* 3 mg GTx-024<br>|
| Placebo Comparator: 3<br>Placebo | Drug: Placebo<br>* Matching Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Efficacy of GTx-024 on Total Body Lean Mass. | Change in total body lean mass as measured by dual energy x-ray absorptiometry (DEXA)from baseline to 4 months. | Baseline to Four Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Assess the Efficacy of GTx-024 on Muscle Function (Performance) as Measured by Stair Climb. | 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]. | Four Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cachexia, Muscle Wasting, Non-Small Cell Lung Cancer, Colorectal Cancer, Non-Hodgkin's Lymphoma, Stage 3 or 4 Breast Cancer, Chronis Lymphocytic Leukemia