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

Cancer Cachexia Clinical Trial

Official title:

A 12-Week, Double-Blind, Randomized, Placebo-Controlled, Parallel Group Phase II Study Comparing the Safety, Tolerability and Beneficial Effects of Daily Doses of RC-1291 and Placebo in Patients With Cancer Anorexia/Cachexia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00378131
• Other study ID #: RC-1291-206
• Status: Completed
• Phase: Phase 2
• First received: September 18, 2006
• Last updated: August 30, 2013
• Start date: September 2006
• Est. completion date: April 2007

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

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 cachexia.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Community-dwelling patients greater than 18 years of age with incurable, histologically diagnosed cancer.

• Involuntary loss of body weight greater than 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 (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cachexia
• Cancer Cachexia

Intervention

Drug:
• RC-1291

• placebo

Locations

Country	Name	City	State
United States	Cancer Outreach Associates	Abingdon	Virginia
United States	Center for Cancer and Blood Disorders	Bethesda	Maryland
United States	Charleston Cancer Center	Charleston	South Carolina
United States	South Carolina Oncology Associates, PA	Columbia	South Carolina
United States	San Diego Pacific Oncology & Hematology Associates	Encinitas	California
United States	University of Texas Medical Branch	Galveston	Texas
United States	Chesapeake Oncology Hematology Associates, PA	Glen Burnie	Maryland
United States	Palo Verde Hematology Oncology, Ltd.	Glendale	Arizona
United States	South Carolina Cancer Specialists	Hilton Head Island	South Carolina
United States	Michael E. DeBakey VA Medical Center	Houston	Texas
United States	Southwest Oncology Associates	Lafayette	Louisiana
United States	Melbourne Internal Medicine Associates	Melbourne	Florida
United States	Beth Israel Cancer Center	New York	New York
United States	Virginia Cancer Institute	Richmond	Virginia
United States	Sant P. Chawla, MD	Santa Monica	California
United States	Multicare Health System	Tacoma	Washington
United States	Northwest Medical Specialties	Tacoma	Washington

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; Lean body mass; Functional performance		4 weeks	No