Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00467844
Recruitment Status : Completed
First Posted : May 1, 2007
Results First Posted : February 21, 2013
Last Update Posted : July 11, 2014
Sponsor:
Information provided by (Responsible Party):
GTx

Tracking Information
First Submitted Date  ICMJE April 30, 2007
First Posted Date  ICMJE May 1, 2007
Results First Submitted Date  ICMJE January 18, 2013
Results First Posted Date  ICMJE February 21, 2013
Last Update Posted Date July 11, 2014
Study Start Date  ICMJE May 2007
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2013)
The Efficacy of GTx-024 on Total Body Lean Mass. [ Time Frame: Baseline to Four Months ]
Change in total body lean mass as measured by dual energy x-ray absorptiometry (DEXA)from baseline to 4 months.
Original Primary Outcome Measures  ICMJE
 (submitted: April 30, 2007)
To Assess the Efficacy of GTx-024 on Total Body Lean Mass. [ Time Frame: Six Months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2013)
To Assess the Efficacy of GTx-024 on Muscle Function (Performance) as Measured by Stair Climb. [ Time Frame: Four Months ]
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].
Original Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2007)
To assess the continued effect of GTx-024 on body weight and survival out to 48 weeks of dosing and to assess the safety and tolerability of GTx-024. [ Time Frame: One year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of GTx-024 on Muscle Wasting (Cachexia) Cancer.
Official Title  ICMJE Double-Blind, Placebo-Controlled, Dose-Finding Study of the Effect of GTx-024 on Muscle Wasting (Cachexia) in Patients With Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Cachexia
Intervention  ICMJE
  • Drug: GTx-024
    1 mg GTx 024
  • Drug: GTx-024
    3 mg GTx-024
  • Drug: Placebo
    Matching Placebo
Study Arms  ICMJE
  • Experimental: 1
    1 mg GTx-024
    Intervention: Drug: GTx-024
  • Experimental: 2
    3 mg GTx-024
    Intervention: Drug: GTx-024
  • Placebo Comparator: 3
    Placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2013)
159
Original Estimated Enrollment  ICMJE
 (submitted: April 30, 2007)
150
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00467844
Other Study ID Numbers  ICMJE G200502
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GTx
Study Sponsor  ICMJE GTx
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account GTx
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP