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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GTx
ClinicalTrials.gov Identifier:
NCT00467844
First received: April 30, 2007
Last updated: June 26, 2014
Last verified: June 2014
  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 2

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

Resource links provided by NLM:


Further study details as provided by GTx:

Primary Outcome Measures:
  • The Efficacy of GTx-024 on Total Body Lean Mass. [ Time Frame: Baseline to Four Months ] [ Designated as safety issue: No ]
    Change in total body lean mass as measured by dual energy x-ray absorptiometry (DEXA)from baseline to 4 months.


Secondary Outcome Measures:
  • To Assess the Efficacy of GTx-024 on Muscle Function (Performance) as Measured by Stair Climb. [ Time Frame: Four Months ] [ Designated as safety issue: No ]
    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].


Enrollment: 159
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
Experimental: 1
1 mg GTx-024
Drug: GTx-024
1 mg GTx 024
Experimental: 2
3 mg GTx-024
Drug: GTx-024
3 mg GTx-024
Placebo Comparator: 3
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 52 Study Locations
Sponsors and Collaborators
GTx
  More Information

No publications provided by GTx

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GTx
ClinicalTrials.gov Identifier: NCT00467844     History of Changes
Obsolete Identifiers: NCT00832104
Other Study ID Numbers: G200502
Study First Received: April 30, 2007
Results First Received: January 18, 2013
Last Updated: June 26, 2014
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

Additional relevant MeSH terms:
Cachexia
Muscular Atrophy
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 16, 2014