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

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.

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Key information

Conditions

Cancer Cachexia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Palo Verde Hematology Oncology Ltd., Glendale, Arizona, 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

Placebo

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: Dec 20, 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