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

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.

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Key information

Conditions

Cancer Cachexia Anorexia Body Weight Body Weight Changes Cachexia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Thinness Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

California Cancer Care Center, Greenbrae, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

RC-1291 HCl

Drug

Primary outcomes

Body Weight
Lean Body Mass
Functional Performance

Sponsors and collaborators

Lead sponsor

Helsinn Therapeutics (U.S.), Inc

Industry

Registry information

Important dates

Study start: 2005
Primary completion: 2006
Study completion: 2006
First posted: Sep 22, 2005
Registry last updated: Sep 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed