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

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ClinicalTrials.gov Identifier: NCT00219817
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : September 2, 2013
Sponsor:
Information provided by:
Helsinn Therapeutics (U.S.), Inc

Brief Summary:
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 or disease Intervention/treatment Phase
Cancer Cachexia Drug: RC-1291 HCl Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : June 2005
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006



Primary Outcome Measures :
  1. Body Weight
  2. Lean Body Mass
  3. Functional Performance


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00219817     History of Changes
Other Study ID Numbers: RC-1291-203
First Posted: September 22, 2005    Key Record Dates
Last Update Posted: September 2, 2013
Last Verified: August 2013

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

Additional relevant MeSH terms:
Cachexia
Wasting Syndrome
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms
Metabolic Diseases
Nutrition Disorders