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

Phase 2

Completed

Conditions: Cachexia

Interventions: Drug: GTx-024
Drug: Placebo

Registration Number: NCT00467844

Lead Sponsor: GTx

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 159

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	GTx-024	3 mg GTx-024
3	Placebo	Placebo
1	GTx-024	1 mg GTx-024

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To Assess the Efficacy of GTx-024 on Muscle Function (Performance) as Measured by Stair Climb.	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)\]/ \[time (seconds) up the 12 steps\].

Trial Locations

Locations (47): Compassionate Cancer Care
🇺🇸
Riverside, California, United States
Johns Hopkins University Clinical Trial Unit
🇺🇸
Baltimore, Maryland, United States
Great Falls Clinic, LLP - Clinic Cancer Care
🇺🇸
Great Falls, Montana, United States
Compassionate Cancer Care Medical Group
🇺🇸
Fountain Valley, California, United States
Desert Hematology Oncology Medical Group
🇺🇸
Rancho Mirage, California, United States
Horizon Institute for Clinical Research
🇺🇸
Hollywood, Florida, United States
Pacific Coast Hematology/Oncology Medical Group, Inc.
🇺🇸
Fountain Valley, California, United States
Dorcy Cancer Center
🇺🇸
Pueblo, Colorado, United States
Hartford Hospital Cancer Clinical Research Office
🇺🇸
Hartford, Connecticut, United States
The Center for Clinical Research WA County Hospital
🇺🇸
Hagerstown, Maryland, United States
Gabrail Cancer Center
🇺🇸
Canton, Ohio, United States
Dallas Oncology Consultants
🇺🇸
Dallas, Texas, United States
Newland Medical Center
🇺🇸
Southfield, Michigan, United States
Hematology & Oncology Associates at Bridgeport
🇺🇸
Tupelo, Mississippi, United States
Princess Margaret Hospital
🇨🇦
Toronto, Ontario, Canada
Cancer Center of Kansas
🇺🇸
Wichita, Kansas, United States
Highlands Oncology Group
🇺🇸
Fayetteville, Arkansas, United States
Penrose Cancer Center
🇺🇸
Colorado Springs, Colorado, United States
Medical Oncology & Hematology, PC
🇺🇸
Waterbury, Connecticut, United States
Gainesville Hematology Oncology Associates
🇺🇸
Gainesville, Florida, United States
The Radiation Oncology Group
🇺🇸
Lake Worth, Florida, United States
Hematology Oncology Associates
🇺🇸
Lake Worth, Florida, United States
Watson Clinic LLP, Center for Cancer Care & Research
🇺🇸
Lakeland, Florida, United States
Osler Medical
🇺🇸
Melbourne, Florida, United States
Dublin Hematology and Oncology
🇺🇸
Dublin, Georgia, United States
Augusta Oncology Associates
🇺🇸
Augusta, Georgia, United States
Florida Medical Clinic, PA
🇺🇸
Zephyrhills, Florida, United States
The West Clinic
🇺🇸
Southaven, Mississippi, United States
West Clinic
🇺🇸
Memphis, Tennessee, United States
Donald H. Berdeaux, MD, FACP, PC
🇺🇸
Great Falls, Montana, United States
Four Seasons Hospice & Palliative Care
🇺🇸
Flat Rock, North Carolina, United States
Hanover Medical Specialists
🇺🇸
Wilmington, North Carolina, United States
Cancer Care of Western North Carolina
🇺🇸
Ashville, North Carolina, United States
Signal Point Clinical Research Center, LLC
🇺🇸
Middletown, Ohio, United States
Hematology Oncology Consultants
🇺🇸
Worthington, Ohio, United States
Urological Associates of Lancaster
🇺🇸
Lancaster, Pennsylvania, United States
Consultants in Medical Oncology and Hematology
🇺🇸
Drexel Hill, Pennsylvania, United States
University of Alberta Cross Cancer Institute
🇨🇦
Edmonton, Alberta, Canada
Berks Hematology-Oncology Associates
🇺🇸
West Reading, Pennsylvania, United States
Providence Everett Medical Center, Cancer Research Department
🇺🇸
Everett, Washington, United States
Innovative Medical Research of South Florida, Inc.
🇺🇸
Miami, Florida, United States
Kentuckiana Cancer Institute
🇺🇸
Louisville, Kentucky, United States
Center for Cancer & Blood Disorders
🇺🇸
Bethesda, Maryland, United States
Heartland Hematology-Oncology Associates
🇺🇸
Kansas City, Missouri, United States
Alaska Cancer Research and Education Center
🇺🇸
Anchorage, Alaska, United States
Creighton University Hematology/Oncology Clinic
🇺🇸
Omaha, Nebraska, United States
Charleston Hematology Oncology Associates
🇺🇸
Charleston, South Carolina, United States