Overview

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

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