Clinical trial NCT00467844: Study of GTx-024 on Muscle Wasting (Cachexia) Cancer.
Official title: Double-Blind, Placebo-Controlled, Dose-Finding Study of the Effect of GTx-024 on Muscle Wasting (Cachexia) in Patients With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cachexia
Keywords: Cachexia
Muscle Wasting
Non-Small Cell Lung Cancer
Colorectal Cancer
Non-Hodgkin's Lymphoma
Stage 3 or 4 Breast Cancer
Chronis Lymphocytic Leukemia
Lead sponsor: GTx
Sponsor class: INDUSTRY
First posted: 2007-05-01
Enrollment: 159
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Efficacy of GTx-024 on Total Body Lean Mass.
timeFrame: Baseline to Four Months
Secondary outcomes:
measure: To Assess the Efficacy of GTx-024 on Muscle Function (Performance) as Measured by Stair Climb.
timeFrame: Four Months
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Cancer Research and Education Center
state: Alaska
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Corona
country: United States
facility: Compassionate Cancer Care
state: California
city: Fountain Valley
country: United States
facility: Compassionate Cancer Care Medical Group
state: California
city: Fountain Valley
country: United States
facility: Pacific Coast Hematology/Oncology Medical Group, Inc.
state: California
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group
state: California
city: Riverside
country: United States
facility: Compassionate Cancer Care
state: California
city: Colorado Springs
country: United States
facility: Penrose Cancer Center
state: Colorado
city: Pueblo
country: United States
facility: Dorcy Cancer Center
state: Colorado
city: Hartford
country: United States
facility: Hartford Hospital Cancer Clinical Research Office
state: Connecticut
city: Waterbury
country: United States
facility: Medical Oncology & Hematology, PC
state: Connecticut
city: Gainesville
country: United States
facility: Gainesville Hematology Oncology Associates
state: Florida
city: Hollywood
country: United States
facility: Horizon Institute for Clinical Research
state: Florida
city: Lake Worth
country: United States
facility: Hematology Oncology Associates
state: Florida
city: Lake Worth
country: United States
facility: The Radiation Oncology Group
state: Florida
city: Lakeland
country: United States
facility: Watson Clinic LLP, Center for Cancer Care & Research
state: Florida
city: Melbourne
country: United States
facility: Osler Medical
state: Florida
city: Miami
country: United States
facility: Innovative Medical Research of South Florida, Inc.
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, PA
state: Florida
city: Augusta
country: United States
facility: Augusta Oncology Associates
state: Georgia
city: Dublin
country: United States
facility: Dublin Hematology and Oncology
state: Georgia
city: Wichita
country: United States
facility: Cancer Center of Kansas
state: Kansas
city: Louisville
country: United States
facility: Kentuckiana Cancer Institute
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University Clinical Trial Unit
state: Maryland
city: Bethesda
country: United States
facility: Center for Cancer & Blood Disorders
state: Maryland
city: Hagerstown
country: United States
facility: The Center for Clinical Research WA County Hospital
state: Maryland
city: Southfield
country: United States
facility: Newland Medical Center
state: Michigan
city: Corinth
country: United States
facility: The West Clinic
state: Mississippi
city: Corinth
country: United States
facility: West Clinic
state: Mississippi
city: Southaven
country: United States
facility: The West Clinic
state: Mississippi
city: Southaven
country: United States
facility: West Clinic
state: Mississippi
city: Tupelo
country: United States
facility: Hematology & Oncology Associates at Bridgeport
state: Mississippi
city: Kansas City
country: United States
facility: Heartland Hematology-Oncology Associates
state: Missouri
city: Great Falls
country: United States
facility: Donald H. Berdeaux, MD, FACP, PC
state: Montana
city: Great Falls
country: United States
facility: Great Falls Clinic, LLP - Clinic Cancer Care
state: Montana
city: Omaha
country: United States
facility: Creighton University Hematology/Oncology Clinic
state: Nebraska
city: Ashville
country: United States
facility: Cancer Care of Western North Carolina
state: North Carolina
city: Flat Rock
country: United States
facility: Four Seasons Hospice & Palliative Care
state: North Carolina
city: Wilmington
country: United States
facility: Hanover Medical Specialists
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Middletown
country: United States
facility: Signal Point Clinical Research Center, LLC
state: Ohio
city: Worthington
country: United States
facility: Hematology Oncology Consultants
state: Ohio
city: Drexel Hill
country: United States
facility: Consultants in Medical Oncology and Hematology
state: Pennsylvania
city: Lancaster
country: United States
facility: Urological Associates of Lancaster
state: Pennsylvania
city: West Reading
country: United States
facility: Berks Hematology-Oncology Associates
state: Pennsylvania
city: Charleston
country: United States
facility: Charleston Hematology Oncology Associates
state: South Carolina
city: Memphis
country: United States
facility: West Clinic
state: Tennessee
city: Memphis
country: United States
facility: West Clinic
state: Tennessee
city: Dallas
country: United States
facility: Dallas Oncology Consultants
state: Texas
city: Everett
country: United States
facility: Providence Everett Medical Center, Cancer Research Department
state: Washington
city: Edmonton
country: Canada
facility: University of Alberta Cross Cancer Institute
state: Alberta
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
References:
citation: 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.