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

Cachexia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00467844
• Other study ID #: G200502
• Status: Completed
• Phase: Phase 2
• First received: April 30, 2007
• Last updated: June 26, 2014
• Start date: May 2007
• Est. completion date: September 2008

Study information

• Verified date: June 2014
• Source: GTx
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00832104

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cachexia
• Muscular Atrophy

Intervention

Drug:
• GTx-024
1 mg GTx 024
• GTx-024
3 mg GTx-024
• Placebo
Matching Placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
GTx

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No