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

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.

Key facts

Study ID

NCT00267358

Run by

Helsinn Therapeutics (U.S.), Inc

Starts

2005-11-01

Expected to finish

2006-10-01

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 ≥ 18 years of age with incurable,histologically diagnosed cancer.
• Involuntary loss of body weight of ≥ 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
• Comprehensive Blood & Cancer Center — Bakersfield, California, United States
• Pacific Oncology & Hematology Associates — Encinitas, California, United States
• Pacific Oncology and Hematology Associates — Encinitas, California, United States
• Advanced Medical Research Institute — Fresno, California, United States
• Kenmar Clinical Research — Los Angeles, California, United States
• Kenmar Research Institute — Los Angeles, California, United States
• Sant Chawla, Inc. — Santa Monica, California, United States
• PAB Clinical Research — Brandon, Florida, United States
• Melbourne Internal Medicine Associates — Melbourne, Florida, United States
• Osler Medical, Inc./ Osler Clinical Research — Melbourne, Florida, United States
• Bay Area Oncology — Tampa, Florida, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• Hematology Oncology Consultants, Inc. — Columbus, Ohio, United States
• Charleston Cancer Center — Charleston, South Carolina, United States
• South Carolina Oncology Associates — Columbia, South Carolina, United States
• South Carolina Cancer Specialists — Hilton Head Island, South Carolina, United States
• University of Texas Medical Texas — Galveston, Texas, United States
• Multicare Health System — Tacoma, Washington, United States

Full record on ClinicalTrials.gov

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