Spots Global Cancer Trial Database for Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia
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Trial Identification
Brief Title: Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia
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
Study ID: NCT00378131
Conditions
Study Description
Brief Summary: 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.
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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Palo Verde Hematology Oncology, Ltd., Glendale, Arizona, United States
San Diego Pacific Oncology & Hematology Associates, Encinitas, California, United States
Sant P. Chawla, MD, Santa Monica, California, United States
Melbourne Internal Medicine Associates, Melbourne, Florida, United States
Southwest Oncology Associates, Lafayette, Louisiana, United States
Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
Chesapeake Oncology Hematology Associates, PA, Glen Burnie, Maryland, United States
Beth Israel Cancer Center, New York, New York, United States
Charleston Cancer Center, Charleston, South Carolina, United States
South Carolina Oncology Associates, PA, Columbia, South Carolina, United States
South Carolina Cancer Specialists, Hilton Head Island, South Carolina, United States
University of Texas Medical Branch, Galveston, Texas, United States
Michael E. DeBakey VA Medical Center, Houston, Texas, United States
Cancer Outreach Associates, Abingdon, Virginia, United States
Virginia Cancer Institute, Richmond, Virginia, United States
Multicare Health System, Tacoma, Washington, United States
Northwest Medical Specialties, Tacoma, Washington, United States
Contact Details
Name: William Polvino, MD
Affiliation: Helsinn Therapeutics (U.S.), Inc
Role: STUDY_DIRECTOR
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