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

Phase 2CompletedNCT00219817

Helsinn Therapeutics (U.S.), Inc80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cancer Cachexia

Interventions

RC-1291 HClDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

California Cancer Care Center

Greenbrae, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Columbia University Medical Center

New York, New York, United States

University of Texas Medical Branch at Galveston

Galveston, Texas, United States

Outcomes

Primary Outcomes

Body Weight

Lean Body Mass

Functional Performance

Data from ClinicalTrials.gov

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