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


Phase 2
N/A
N/A
Not Enrolling
Both
Cachexia

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Trial Information

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


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.


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

Type of Study:

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

Outcome Measure:

The Efficacy of GTx-024 on Total Body Lean Mass.

Outcome Description:

Change in total body lean mass as measured by dual energy x-ray absorptiometry (DEXA)from baseline to 4 months.

Outcome Time Frame:

Baseline to Four Months

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

G200502

NCT ID:

NCT00467844

Start Date:

May 2007

Completion Date:

September 2008

Related Keywords:

  • Cachexia
  • Cachexia
  • Muscle Wasting
  • Non-Small Cell Lung Cancer
  • Colorectal Cancer
  • Non-Hodgkin's Lymphoma
  • Stage 3 or 4 Breast Cancer
  • Chronis Lymphocytic Leukemia
  • Cachexia
  • Muscular Atrophy

Name

Location

Hematology Oncology AssociatesAtlantis, Florida  33462
Penrose Cancer CenterColorado Springs, Colorado  80933
Highlands Oncology GroupSpringdale, Arkansas  72764
Kentuckiana Cancer InstituteLouisville, Kentucky  40202
West ClinicMemphis, Tennessee  38117
Innovative Medical Research of South Florida, Inc.Miami, Florida  33138
Augusta Oncology AssociatesAugusta, Georgia  30901
Urological Associates Of LancasterLancaster, Pennsylvania  17604-3200
Gabrail Cancer CenterCanton, Ohio  44718
Pacific Coast Hematology/Oncology Medical Group, Inc.Fountain Valley, California  92708
Florida Medical Clinic, PAZephyrhills, Florida  33542
Dallas Oncology ConsultantsDallas, Texas  75201
Center for Cancer & Blood DisordersBethesda, Maryland  20817
Cancer Care of Western North CarolinaAsheville, North Carolina  28801
Alaska Cancer Research and Education CenterAnchorage, Alaska  99508
Cancer Center of KansasWichita, Kansas  67214
Hanover Medical SpecialistsWilmington, North Carolina  28401
Gainesville Hematology Oncology AssociatesGainesville, Florida  32605
Osler MedicalWest Melbourne, Florida  32901
Desert Hematology Oncology Medical GroupRancho Mirage, California  92270
Compassionate Cancer Care Medical GroupCorona, California  92882
Consultants in Medical Oncology and HematologyDrexel Hill, Pennsylvania  19026
The West ClinicCorinth, Mississippi  38834
Signal Point Clinical Research Center, LLCMiddletown, Ohio  45042
Compassionate Cancer CareCorona, California  92882
Dorcy Cancer CenterPueblo, Colorado  81004
Hartford Hospital Cancer Clinical Research OfficeHartford, Connecticut  06102
Medical Oncology & Hematology, PCWaterbury, Connecticut  06708
Horizon Institute for Clinical ResearchHollywood, Florida  33021
The Radiation Oncology GroupLake Worth, Florida  33461
Watson Clinic LLP, Center for Cancer Care & ResearchLakeland, Florida  33805
Dublin Hematology and OncologyDublin, Georgia  31021
Johns Hopkins University Clinical Trial UnitBaltimore, Maryland  21287
The Center for Clinical Research WA County HospitalHagerstown, Maryland  21740
Newland Medical CenterSouthfield, Michigan  48075
West ClinicCorinth, Mississippi  38834
Hematology & Oncology Associates at BridgeportTupelo, Mississippi  38801
Heartland Hematology-Oncology AssociatesKansas City, Missouri  64118
Great Falls Clinic, LLP - Clinic Cancer CareGreat Falls, Montana  59405
Donald H. Berdeaux, MD, FACP, PCGreat Falls, Montana  59405
Creighton University Hematology/Oncology ClinicOmaha, Nebraska  68131
Four Seasons Hospice & Palliative CareFlat Rock, North Carolina  28731
Hematology Oncology ConsultantsWorthington, Ohio  43235
Berks Hematology-Oncology AssociatesWest Reading, Pennsylvania  19611
Charleston Hematology Oncology AssociatesCharleston, South Carolina  29403
Providence Everett Medical Center, Cancer Research DepartmentEverett, Washington  98201