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

This study has been completed.

First Received: September 12, 2005 Last Updated: June 30, 2009 History of Changes

Sponsored by:	Helsinn Therapeutics (U.S.), Inc
Information provided by:	Helsinn Therapeutics (U.S.), Inc
ClinicalTrials.gov Identifier:	NCT00219817

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Cancer Weight Control

U.S. FDA Resources

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

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
Michael E. DeBakey Veterans Affairs Medical Center
Houston, Texas, United States, 77030
University of Texas Medical Branch at Galveston
Galveston, Texas, United States, 77555
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

Study ID Numbers:	RC-1291-203
Study First Received:	September 12, 2005
Last Updated:	June 30, 2009
ClinicalTrials.gov Identifier:	NCT00219817 History of Changes
Health Authority:	United States: Food and Drug Administration

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

Anorexia
Cachexia

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Weight Loss
Body Weight Changes

Anorexia
Cachexia
Emaciation

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Weight Loss

Body Weight Changes
Cachexia
Emaciation

ClinicalTrials.gov processed this record on September 01, 2009