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

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

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.

Study Overview

• Status: Completed
• Conditions: Cachexia
• Intervention / Treatment: Drug: Placebo; Drug: GTx-024; Drug: GTx-024

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.

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
      • University of Alberta Cross Cancer Institute
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital
• United States
  • Alaska
    • Anchorage, Alaska, United States, 99508
      • Alaska Cancer Research and Education Center
  • Arkansas
    • Fayetteville, Arkansas, United States, 72703
      • Highlands Oncology Group
  • California
    • Corona, California, United States, 92882
      • Compassionate Cancer Care
    • Fountain Valley, California, United States, 92708
      • Pacific Coast Hematology/Oncology Medical Group, Inc.
    • Fountain Valley, California, United States, 92708
      • Compassionate Cancer Care Medical Group
    • Rancho Mirage, California, United States, 92270
      • Desert Hematology Oncology Medical Group
    • Riverside, California, United States, 92501
      • Compassionate Cancer Care
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Penrose Cancer Center
    • Pueblo, Colorado, United States, 81004
      • Dorcy Cancer Center
  • Connecticut
    • Hartford, Connecticut, United States, 06102
      • Hartford Hospital Cancer Clinical Research Office
    • Waterbury, Connecticut, United States, 06708
      • Medical Oncology & Hematology, PC
  • Florida
    • Gainesville, Florida, United States, 32605
      • Gainesville Hematology Oncology Associates
    • Hollywood, Florida, United States, 33021
      • Horizon Institute for Clinical Research
    • Lake Worth, Florida, United States, 33461
      • Hematology Oncology Associates
    • Lake Worth, Florida, United States, 33461
      • The Radiation Oncology Group
    • Lakeland, Florida, United States, 33805
      • Watson Clinic LLP, Center for Cancer Care & Research
    • Melbourne, Florida, United States, 32901
      • Osler Medical
    • Miami, Florida, United States, 33179
      • Innovative Medical Research of South Florida, Inc.
    • Zephyrhills, Florida, United States, 33542
      • Florida Medical Clinic, PA
  • Georgia
    • Augusta, Georgia, United States, 30901
      • Augusta Oncology Associates
    • Dublin, Georgia, United States, 31021
      • Dublin Hematology and Oncology
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Kentuckiana Cancer Institute
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University Clinical Trial Unit
    • Bethesda, Maryland, United States, 20817
      • Center for Cancer & Blood Disorders
    • Hagerstown, Maryland, United States, 21740
      • The Center for Clinical Research WA County Hospital
  • Michigan
    • Southfield, Michigan, United States, 48075
      • Newland Medical Center
  • Mississippi
    • Corinth, Mississippi, United States, 38834
      • The West Clinic
    • Corinth, Mississippi, United States, 38834
      • West Clinic
    • Southaven, Mississippi, United States, 38671
      • The West Clinic
    • Southaven, Mississippi, United States, 38671
      • West Clinic
    • Tupelo, Mississippi, United States, 38801
      • Hematology & Oncology Associates at Bridgeport
  • Missouri
    • Kansas City, Missouri, United States, 64118
      • Heartland Hematology-Oncology Associates
  • Montana
    • Great Falls, Montana, United States, 59405
      • Donald H. Berdeaux, MD, FACP, PC
    • Great Falls, Montana, United States, 59405
      • Great Falls Clinic, LLP - Clinic Cancer Care
  • Nebraska
    • Omaha, Nebraska, United States, 68131
      • Creighton University Hematology/Oncology Clinic
  • North Carolina
    • Ashville, North Carolina, United States, 28801
      • Cancer Care of Western North Carolina
    • Flat Rock, North Carolina, United States, 28731
      • Four Seasons Hospice & Palliative Care
    • Wilmington, North Carolina, United States, 28401
      • Hanover Medical Specialists
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center
    • Middletown, Ohio, United States, 45042
      • Signal Point Clinical Research Center, LLC
    • Worthington, Ohio, United States, 43235
      • Hematology Oncology Consultants
  • Pennsylvania
    • Drexel Hill, Pennsylvania, United States, 19026
      • Consultants in Medical Oncology and Hematology
    • Lancaster, Pennsylvania, United States, 17604
      • Urological Associates of Lancaster
    • West Reading, Pennsylvania, United States, 19611
      • Berks Hematology-Oncology Associates
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • Charleston Hematology Oncology Associates
  • Tennessee
    • Memphis, Tennessee, United States, 38120
      • West Clinic
    • Memphis, Tennessee, United States, 38104
      • West Clinic
  • Texas
    • Dallas, Texas, United States, 75237
      • Dallas Oncology Consultants
  • Washington
    • Everett, Washington, United States, 98201
      • Providence Everett Medical Center, Cancer Research Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 3; Placebo	Drug: Placebo; Matching Placebo
Experimental: 1; 1 mg GTx-024	Drug: GTx-024; 1 mg GTx 024; Drug: GTx-024; 3 mg GTx-024
Experimental: 2; 3 mg GTx-024	Drug: GTx-024; 1 mg GTx 024; Drug: GTx-024; 3 mg GTx-024

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GTx

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: April 30, 2007
• First Submitted That Met QC Criteria: April 30, 2007
• First Posted (Estimate): May 1, 2007

Study Record Updates

• Last Update Posted (Estimate): July 11, 2014
• Last Update Submitted That Met QC Criteria: June 26, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Non-Small Cell Lung Cancer; Colorectal Cancer; Non-Hodgkin's Lymphoma; Cachexia; Muscle Wasting; Stage 3 or 4 Breast Cancer; Chronis Lymphocytic Leukemia
• Additional Relevant MeSH Terms: Metabolic Diseases; Nervous System Diseases; Neurologic Manifestations; Nutrition Disorders; Body Weight; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Body Weight Changes; Atrophy; Emaciation; Weight Loss; Muscular Atrophy; Wasting Syndrome; Cachexia
• Other Study ID Numbers: G200502