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Phase 2
18 Years
N/A
Not Enrolling
Both
Cancer Cachexia

Thank you

Trial Information


Inclusion Criteria:



- Community-dwelling patients ≥ 18 years of age with incurable, histologically
diagnosed cancer.

- Involuntary loss of body weight of ≥ 5 % within the past 6 months

Exclusion Criteria:

- Presently hospitalized or in a nursing care facility.

- Inability to increase food intake from secondary causes.

- Liver disease

- If female-pregnant, breast-feeding or of childbearing potential.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Body Weight

Principal Investigator

William Polvino, MD

Investigator Role:

Study Director

Investigator Affiliation:

Sapphire Therapeutics

Authority:

United States: Food and Drug Administration

Study ID:

RC-1291-203

NCT ID:

NCT00219817

Start Date:

June 2005

Completion Date:

October 2006

Related Keywords:

  • Cancer Cachexia
  • Anorexia
  • Cachexia
  • Cachexia

Name

Location

Fletcher Allen Health CareBurlington, Vermont  05401
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Columbia University Medical CenterNew York, New York  10032
Cancer Outreach AssociatesAbingdon, Virginia  24211
California Cancer Care CenterGreenbrae, California  94904
University of Texas Medical Branch at GalvestonGalveston, Texas  77555
Michael E. DeBakey Veterans Affairs Medical CenterHouston, Texas  77030