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

Cancer Cachexia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00219817
• Other study ID #: RC-1291-203
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: August 30, 2013
• Start date: June 2005
• Est. completion date: October 2006

Study information

• Verified date: August 2013
• Source: Helsinn Therapeutics (U.S.), Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 2006
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cachexia
• Cancer Cachexia

Intervention

Drug:
• RC-1291 HCl

Locations

Country	Name	City	State
United States	Cancer Outreach Associates	Abingdon	Virginia
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Fletcher Allen Health Care	Burlington	Vermont
United States	University of Texas Medical Branch at Galveston	Galveston	Texas
United States	California Cancer Care Center	Greenbrae	California
United States	Michael E. DeBakey Veterans Affairs Medical Center	Houston	Texas
United States	Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Helsinn Therapeutics (U.S.), Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Weight
Primary	Lean Body Mass
Primary	Functional Performance