Safety and Efficacy of RC-1291 HCl in Patients With Cancer Related Anorexia and Weight Loss

• Status: Completed
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

Summary

Anorexia and weight loss 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 weight loss. This study will test the safety and efficacy of RC-1291 in the treatment of cancer patients with anorexia and weight loss.

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

Details

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

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.