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

Primary Purpose

Cachexia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GTx-024
GTx-024
Placebo
Sponsored by
GTx
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cachexia focused on measuring Cachexia, Muscle Wasting, Non-Small Cell Lung Cancer, Colorectal Cancer, Non-Hodgkin's Lymphoma, Stage 3 or 4 Breast Cancer, Chronis Lymphocytic Leukemia

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alaska Cancer Research and Education Center
  • Highlands Oncology Group
  • Compassionate Cancer Care
  • Compassionate Cancer Care Medical Group
  • Pacific Coast Hematology/Oncology Medical Group, Inc.
  • Desert Hematology Oncology Medical Group
  • Compassionate Cancer Care
  • Penrose Cancer Center
  • Dorcy Cancer Center
  • Hartford Hospital Cancer Clinical Research Office
  • Medical Oncology & Hematology, PC
  • Gainesville Hematology Oncology Associates
  • Horizon Institute for Clinical Research
  • Hematology Oncology Associates
  • The Radiation Oncology Group
  • Watson Clinic LLP, Center for Cancer Care & Research
  • Osler Medical
  • Innovative Medical Research of South Florida, Inc.
  • Florida Medical Clinic, PA
  • Augusta Oncology Associates
  • Dublin Hematology and Oncology
  • Cancer Center of Kansas
  • Kentuckiana Cancer Institute
  • Johns Hopkins University Clinical Trial Unit
  • Center for Cancer & Blood Disorders
  • The Center for Clinical Research WA County Hospital
  • Newland Medical Center
  • The West Clinic
  • West Clinic
  • The West Clinic
  • West Clinic
  • Hematology & Oncology Associates at Bridgeport
  • Heartland Hematology-Oncology Associates
  • Donald H. Berdeaux, MD, FACP, PC
  • Great Falls Clinic, LLP - Clinic Cancer Care
  • Creighton University Hematology/Oncology Clinic
  • Cancer Care of Western North Carolina
  • Four Seasons Hospice & Palliative Care
  • Hanover Medical Specialists
  • Gabrail Cancer Center
  • Signal Point Clinical Research Center, LLC
  • Hematology Oncology Consultants
  • Consultants in Medical Oncology and Hematology
  • Urological Associates of Lancaster
  • Berks Hematology-Oncology Associates
  • Charleston Hematology Oncology Associates
  • West Clinic
  • West Clinic
  • Dallas Oncology Consultants
  • Providence Everett Medical Center, Cancer Research Department
  • University of Alberta Cross Cancer Institute
  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

1 mg GTx-024

3 mg GTx-024

Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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].

Full Information

First Posted
April 30, 2007
Last Updated
June 26, 2014
Sponsor
GTx
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1. Study Identification

Unique Protocol Identification Number
NCT00467844
Brief Title
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GTx

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
1 mg GTx-024
Arm Title
2
Arm Type
Experimental
Arm Description
3 mg GTx-024
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
GTx-024
Intervention Description
1 mg GTx 024
Intervention Type
Drug
Intervention Name(s)
GTx-024
Intervention Description
3 mg GTx-024
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo
Primary Outcome Measure Information:
Title
The Efficacy of GTx-024 on Total Body Lean Mass.
Description
Change in total body lean mass as measured by dual energy x-ray absorptiometry (DEXA)from baseline to 4 months.
Time Frame
Baseline to Four Months
Secondary Outcome Measure Information:
Title
To Assess the Efficacy of GTx-024 on Muscle Function (Performance) as Measured by Stair Climb.
Description
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].
Time Frame
Four Months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Alaska Cancer Research and Education Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Highlands Oncology Group
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72703
Country
United States
Facility Name
Compassionate Cancer Care
City
Corona
State/Province
California
ZIP/Postal Code
92882
Country
United States
Facility Name
Compassionate Cancer Care Medical Group
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Pacific Coast Hematology/Oncology Medical Group, Inc.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
Desert Hematology Oncology Medical Group
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Compassionate Cancer Care
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
Penrose Cancer Center
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Dorcy Cancer Center
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81004
Country
United States
Facility Name
Hartford Hospital Cancer Clinical Research Office
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Medical Oncology & Hematology, PC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Gainesville Hematology Oncology Associates
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Horizon Institute for Clinical Research
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Hematology Oncology Associates
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
The Radiation Oncology Group
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
Facility Name
Watson Clinic LLP, Center for Cancer Care & Research
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Osler Medical
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Innovative Medical Research of South Florida, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33179
Country
United States
Facility Name
Florida Medical Clinic, PA
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Augusta Oncology Associates
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Dublin Hematology and Oncology
City
Dublin
State/Province
Georgia
ZIP/Postal Code
31021
Country
United States
Facility Name
Cancer Center of Kansas
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Kentuckiana Cancer Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Johns Hopkins University Clinical Trial Unit
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Center for Cancer & Blood Disorders
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
The Center for Clinical Research WA County Hospital
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Newland Medical Center
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
The West Clinic
City
Corinth
State/Province
Mississippi
ZIP/Postal Code
38834
Country
United States
Facility Name
West Clinic
City
Corinth
State/Province
Mississippi
ZIP/Postal Code
38834
Country
United States
Facility Name
The West Clinic
City
Southaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Facility Name
West Clinic
City
Southaven
State/Province
Mississippi
ZIP/Postal Code
38671
Country
United States
Facility Name
Hematology & Oncology Associates at Bridgeport
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Heartland Hematology-Oncology Associates
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64118
Country
United States
Facility Name
Donald H. Berdeaux, MD, FACP, PC
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Great Falls Clinic, LLP - Clinic Cancer Care
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Creighton University Hematology/Oncology Clinic
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Cancer Care of Western North Carolina
City
Ashville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Four Seasons Hospice & Palliative Care
City
Flat Rock
State/Province
North Carolina
ZIP/Postal Code
28731
Country
United States
Facility Name
Hanover Medical Specialists
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Signal Point Clinical Research Center, LLC
City
Middletown
State/Province
Ohio
ZIP/Postal Code
45042
Country
United States
Facility Name
Hematology Oncology Consultants
City
Worthington
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Consultants in Medical Oncology and Hematology
City
Drexel Hill
State/Province
Pennsylvania
ZIP/Postal Code
19026
Country
United States
Facility Name
Urological Associates of Lancaster
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Berks Hematology-Oncology Associates
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Charleston Hematology Oncology Associates
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Facility Name
West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Dallas Oncology Consultants
City
Dallas
State/Province
Texas
ZIP/Postal Code
75237
Country
United States
Facility Name
Providence Everett Medical Center, Cancer Research Department
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
University of Alberta Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23499390
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.
Results Reference
derived

Learn more about this trial

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

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