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CachexiaPhase 2NCT00467844

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

A Phase 2 study testing GTx-024 in people with Cachexia, run by GTx at 52 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Cachexia
What is being tested?
GTx-024
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
159 participants
Where
52 sitesin 2 countries
Study dates
May 2007to Sep 2008
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • have a life expectancy of >6 months
  • FEMALES - be clinically confirmed as postmenopausal
  • MALES - over 45 years of age
  • ECOG score ≤1

Who cannot join

  • 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

Trial locations and contacts

52 sites in 2 countries.

52 sites in 2 countries

United States50 sites

  • Alaska Cancer Research and Education Center

    Anchorage, Alaska, 99508

  • Cancer Care of Western North Carolina

    Ashville, North Carolina, 28801

  • Augusta Oncology Associates

    Augusta, Georgia, 30901

  • Johns Hopkins University Clinical Trial Unit

    Baltimore, Maryland, 21287

  • Center for Cancer & Blood Disorders

    Bethesda, Maryland, 20817

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Charleston Hematology Oncology Associates

    Charleston, South Carolina, 29403

  • Penrose Cancer Center

    Colorado Springs, Colorado, 80907

  • The West Clinic

    Corinth, Mississippi, 38834

  • West Clinic

    Corinth, Mississippi, 38834

  • Compassionate Cancer Care

    Corona, California, 92882

  • Dallas Oncology Consultants

    Dallas, Texas, 75237

  • Consultants in Medical Oncology and Hematology

    Drexel Hill, Pennsylvania, 19026

  • Dublin Hematology and Oncology

    Dublin, Georgia, 31021

  • Providence Everett Medical Center, Cancer Research Department

    Everett, Washington, 98201

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • Four Seasons Hospice & Palliative Care

    Flat Rock, North Carolina, 28731

  • Compassionate Cancer Care Medical Group

    Fountain Valley, California, 92708

  • Pacific Coast Hematology/Oncology Medical Group, Inc.

    Fountain Valley, California, 92708

  • Gainesville Hematology Oncology Associates

    Gainesville, Florida, 32605

  • Donald H. Berdeaux, MD, FACP, PC

    Great Falls, Montana, 59405

  • Great Falls Clinic, LLP - Clinic Cancer Care

    Great Falls, Montana, 59405

  • The Center for Clinical Research WA County Hospital

    Hagerstown, Maryland, 21740

  • Hartford Hospital Cancer Clinical Research Office

    Hartford, Connecticut, 06102

  • Horizon Institute for Clinical Research

    Hollywood, Florida, 33021

  • Heartland Hematology-Oncology Associates

    Kansas City, Missouri, 64118

  • Hematology Oncology Associates

    Lake Worth, Florida, 33461

  • The Radiation Oncology Group

    Lake Worth, Florida, 33461

  • Watson Clinic LLP, Center for Cancer Care & Research

    Lakeland, Florida, 33805

  • Urological Associates of Lancaster

    Lancaster, Pennsylvania, 17604

  • Kentuckiana Cancer Institute

    Louisville, Kentucky, 40202

  • Osler Medical

    Melbourne, Florida, 32901

  • West Clinic

    Memphis, Tennessee, 38104

  • West Clinic

    Memphis, Tennessee, 38120

  • Innovative Medical Research of South Florida, Inc.

    Miami, Florida, 33179

  • Signal Point Clinical Research Center, LLC

    Middletown, Ohio, 45042

  • Creighton University Hematology/Oncology Clinic

    Omaha, Nebraska, 68131

  • Dorcy Cancer Center

    Pueblo, Colorado, 81004

  • Desert Hematology Oncology Medical Group

    Rancho Mirage, California, 92270

  • Compassionate Cancer Care

    Riverside, California, 92501

  • The West Clinic

    Southaven, Mississippi, 38671

  • West Clinic

    Southaven, Mississippi, 38671

  • Newland Medical Center

    Southfield, Michigan, 48075

  • Hematology & Oncology Associates at Bridgeport

    Tupelo, Mississippi, 38801

  • Medical Oncology & Hematology, PC

    Waterbury, Connecticut, 06708

  • Berks Hematology-Oncology Associates

    West Reading, Pennsylvania, 19611

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

  • Hanover Medical Specialists

    Wilmington, North Carolina, 28401

  • Hematology Oncology Consultants

    Worthington, Ohio, 43235

  • Florida Medical Clinic, PA

    Zephyrhills, Florida, 33542

Other trials in United States

Canada2 sites

  • University of Alberta Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Princess Margaret Hospital

    Toronto, Ontario, M5G 2M9

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions
Cachexia
Being tested
GTx-024, Placebo
Keywords
Cachexia, Muscle Wasting, Non-Small Cell Lung Cancer, Colorectal Cancer, Non-Hodgkin's Lymphoma, Stage 3 or 4 Breast Cancer, Chronis Lymphocytic Leukemia
Medical subject headings
Cachexia, Muscular Atrophy, Carcinoma, Non-Small-Cell Lung, Colorectal Neoplasms, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GTx-024Drug

    1 mg GTx 024

  • GTx-024Drug

    3 mg GTx-024

  • PlaceboDrug

    Matching Placebo

Study groups in NCT00467844
Study groupRoleWhat they receive
1Experimental1 mg GTx-024
Receives: Drug: GTx-024
2Experimental3 mg GTx-024
Receives: Drug: GTx-024
3Placebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to Four Months

Secondary outcomes (1)

  1. 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].

    Measured: Four Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2007 (estimated)
  2. Study startMay 2007
  3. Primary completionSep 2008
  4. Study completionSep 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00467844
Sponsor's protocol ID
G200502
Status last verified
Jun 2014
First submitted
30 Apr 2007
Last updated
11 Jul 2014
Data monitoring committee
No

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.

    PubMed 23499390

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GTx-024 in people with Cachexia, run by GTx at 52 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Efficacy of GTx-024 on Total Body Lean Mass. (time frame: Baseline to Four Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00467844, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2014.

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