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

Completed · Phase 2 · Has a placebo group

Conditions studied: Cancer Cachexia

In brief

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.

Key facts

Study ID

NCT00378131

Run by

Helsinn Therapeutics (U.S.), Inc

People needed

51

Starts

2006-09-01

Expected to finish

2007-04-01

Last updated by the study team

2013-09-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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