Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia

This study has been completed.
Sponsor:
Information provided by:
Helsinn Therapeutics (U.S.), Inc
ClinicalTrials.gov Identifier:
NCT00378131
First received: September 18, 2006
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

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 cachexia. This placebo controlled study will evaluate the safety and efficacy of RC-1291 HCl in cancer patients with cachexia.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Phase II Study Comparing the Safety, Tolerability and Beneficial Effects of Daily Doses of RC-1291 and Placebo in Patients With Cancer Anorexia/Cachexia

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 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 51
Study Start Date: September 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1 Drug: placebo
Experimental: 2
RC-1291 50mg
Drug: RC-1291
Experimental: 3
RC-1291 100mg
Drug: RC-1291

Detailed Description:

Anorexia and cachexia 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 cachexia. This placebo controlled study will evaluate the safety and efficacy of RC-1291 HCl in cancer patients with anorexia and cachexia.

  Eligibility

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

Inclusion Criteria:

  • Community-dwelling patients greater than 18 years of age with incurable, histologically diagnosed cancer.
  • Involuntary loss of body weight greater than 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: NCT00378131

Locations
United States, Arizona
Palo Verde Hematology Oncology, Ltd.
Glendale, Arizona, United States, 85304
United States, California
San Diego Pacific Oncology & Hematology Associates
Encinitas, California, United States, 92024
Sant P. Chawla, MD
Santa Monica, California, United States, 90403
United States, Florida
Melbourne Internal Medicine Associates
Melbourne, Florida, United States, 32901
United States, Louisiana
Southwest Oncology Associates
Lafayette, Louisiana, United States, 70503
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
Chesapeake Oncology Hematology Associates, PA
Glen Burnie, Maryland, United States, 21061
United States, New York
Beth Israel Cancer Center
New York, New York, United States, 10003
United States, South Carolina
Charleston Cancer Center
Charleston, South Carolina, United States, 29406
South Carolina Oncology Associates, PA
Columbia, South Carolina, United States, 29210
South Carolina Cancer Specialists
Hilton Head Island, South Carolina, United States, 29926
United States, Texas
University of Texas Medical Branch
Galveston, Texas, United States, 77555
Michael E. DeBakey VA Medical Center
Houston, Texas, United States, 77030
United States, Virginia
Cancer Outreach Associates
Abingdon, Virginia, United States, 24211
Virginia Cancer Institute
Richmond, Virginia, United States, 23230
United States, Washington
Multicare Health System
Tacoma, Washington, United States, 98405
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Helsinn Therapeutics (U.S.), Inc
Investigators
Study Director: William Polvino, MD Helsinn Therapeutics (U.S.), Inc
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00378131     History of Changes
Other Study ID Numbers: RC-1291-206
Study First Received: September 18, 2006
Last Updated: August 30, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014