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Safety and Efficacy of RC-1291 HCl in Patients With Cancer Related Anorexia and Weight Loss

This study has been completed.
Sponsor:
Information provided by:
Helsinn Therapeutics (U.S.), Inc
ClinicalTrials.gov Identifier:
NCT00219817
First received: September 12, 2005
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

Anorexia and weight loss are devastating complications in late-stage cancer patients and is strongly associated with mortality in these patients. Activation of Ghrelin receptors have been demonstrated to stimulate appetite. RC-1291 HCl, by virtue of its ghrelin like activity and Growth Hormone releasing effects may have a dual role in the reversal of cancer induced anorexia and weight loss. This study will test the safety and efficacy of RC-1291 in the treatment of cancer patients with anorexia and weight loss.


Condition Intervention Phase
Cancer Cachexia
Drug: RC-1291 HCl
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Helsinn Therapeutics (U.S.), Inc:

Primary Outcome Measures:
  • Body Weight
  • Lean Body Mass
  • Functional Performance

Estimated Enrollment: 80
Study Start Date: June 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00219817

Locations
United States, California
California Cancer Care Center
Greenbrae, California, United States, 94904
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, Texas
University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, United States, 77030
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
United States, Virginia
Cancer Outreach Associates
Abingdon, Virginia, United States, 24211
Sponsors and Collaborators
Helsinn Therapeutics (U.S.), Inc
Investigators
Study Director: William Polvino, MD Sapphire Therapeutics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00219817     History of Changes
Other Study ID Numbers: RC-1291-203
Study First Received: September 12, 2005
Last Updated: August 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Helsinn Therapeutics (U.S.), Inc:
Anorexia
Cachexia

Additional relevant MeSH terms:
Cachexia
Body Weight
Body Weight Changes
Emaciation
Signs and Symptoms
Weight Loss

ClinicalTrials.gov processed this record on November 23, 2014