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

Helsinn Healthcare

Status and phase: Completed; Phase 2

Conditions: Cancer Cachexia

Treatments: Drug: RC-1291 HCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT00219817

RC-1291-203

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind