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

Sponsored by:	GTx
Information provided by:	GTx
ClinicalTrials.gov Identifier:	NCT00467844

Purpose

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.

Condition	Intervention	Phase
Cachexia	Drug: GTx-024 Drug: Placebo	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Double-Blind, Placebo-Controlled, Dose-Finding Study of the Effect of GTx-024 on Muscle Wasting (Cachexia) in Patients With Cancer

Further study details as provided by GTx:

Primary Outcome Measures:

To assess the efficacy of GTx-024 on total body lean mass. [ Time Frame: Four Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess the effect of GTx-024 on body weight, muscle function and total body fat mass. [ Time Frame: Four Months ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	May 2007
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 1 MG	Drug: GTx-024 1 mg GTx 024
2: Experimental 3 mg	Drug: GTx-024 3 mg GTx-024
3: Placebo Comparator Placebo	Drug: Placebo Matching Placebo

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00467844

Show 52 Study Locations

Sponsors and Collaborators

GTx

More Information

Responsible Party:	GTx ( Ronald Morton, MD, CMO )
Study ID Numbers:	G200502
Study First Received:	April 30, 2007
Last Updated:	November 20, 2008
ClinicalTrials.gov Identifier:	NCT00467844
Health Authority:	United States: Food and Drug Administration

Keywords provided by GTx:

Cachexia
Muscle Wasting
Non-Small Cell Lung Cancer
Colorectal Cancer

Non-Hodgkin's Lymphoma
Stage 3 or 4 Breast Cancer
Chronis Lymphocytic Leukemia

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Non-small cell lung cancer
Leukemia, Lymphoid
Lymphoma, small cleaved-cell, diffuse
Breast Neoplasms
Cachexia
Emaciation
Body Weight
Leukemia
Signs and Symptoms

Lung Neoplasms
Weight Loss
Body Weight Changes
Neurologic Manifestations
Atrophy
Lymphoma, Non-Hodgkin
Lymphoma
Carcinoma, Non-Small-Cell Lung
Colorectal Neoplasms
Muscular Atrophy

Additional relevant MeSH terms:

Neuromuscular Manifestations
Nervous System Diseases

ClinicalTrials.gov processed this record on January 15, 2009