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:
NCT00267358
First received: December 19, 2005
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

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

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

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

Study Start Date: November 2005
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: RC-1291 HCl
50 mg
Drug: RC-1291 HCl
Placebo Comparator: Placebo Drug: Placebo

  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: NCT00267358

Locations
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 and Hematology Associates
Encinitas, California, United States, 92024
Pacific Oncology & Hematology Associates
Encinitas, California, United States, 92024
Advanced Medical Research Institute
Fresno, California, United States, 93710
Kenmar Research Institute
Los Angeles, California, United States, 90057
Kenmar Clinical Research
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
Osler Medical, Inc./ Osler Clinical Research
Melbourne, Florida, United States, 32901
Melbourne Internal Medicine Associates
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
Investigators
Study Director: William Polvino, MD Helsinn Therapeutics (U.S.), Inc
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00267358     History of Changes
Other Study ID Numbers: RC-1291-205
Study First Received: December 19, 2005
Last Updated: August 30, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 28, 2014