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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00267358
Recruitment Status : Completed
First Posted : December 20, 2005
Last Update Posted : September 2, 2013
Information provided by:
Helsinn Therapeutics (U.S.), Inc

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cancer Cachexia Drug: RC-1291 HCl Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Study Start Date : November 2005
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Arm Intervention/treatment
Active Comparator: RC-1291 HCl
50 mg
Drug: RC-1291 HCl
Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. Body weight
  2. Lean body mass
  3. Functional performance

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT00267358

United States, Arizona
Palo Verde Hematology Oncology Ltd.
Glendale, Arizona, United States, 85304
United States, California
Comprehensive Blood & Cancer Center
Bakersfield, California, United States, 93309
Pacific Oncology & Hematology Associates
Encinitas, California, United States, 92024
Pacific Oncology and Hematology Associates
Encinitas, California, United States, 92024
Advanced Medical Research Institute
Fresno, California, United States, 93710
Kenmar Clinical Research
Los Angeles, California, United States, 90057
Kenmar Research Institute
Los Angeles, California, United States, 90057
Sant Chawla, Inc.
Santa Monica, California, United States, 90403
United States, Florida
PAB Clinical Research
Brandon, Florida, United States, 33511
Melbourne Internal Medicine Associates
Melbourne, Florida, United States, 32901
Osler Medical, Inc./ Osler Clinical Research
Melbourne, Florida, United States, 32901
Bay Area Oncology
Tampa, Florida, United States, 33607
United States, Maryland
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States, 20817
United States, Ohio
Hematology Oncology Consultants, Inc.
Columbus, Ohio, United States, 43235
United States, South Carolina
Charleston Cancer Center
Charleston, South Carolina, United States, 29406
South Carolina Oncology Associates
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 Texas
Galveston, Texas, United States, 77555
United States, Washington
Multicare Health System
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Helsinn Therapeutics (U.S.), Inc
Study Director: William Polvino, MD Helsinn Therapeutics (U.S.), Inc

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00267358     History of Changes
Other Study ID Numbers: RC-1291-205
First Posted: December 20, 2005    Key Record Dates
Last Update Posted: September 2, 2013
Last Verified: August 2013

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