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

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Helsinn Therapeutics (U.S.), Inc

Criteria

Inclusion Criteria:

• 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

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.