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

Cancer Cachexia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00267358
• Other study ID #: RC-1291-205
• Status: Completed
• Phase: Phase 2
• First received: December 19, 2005
• Last updated: August 30, 2013
• Start date: November 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 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: 0
• 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

Related Conditions & MeSH terms

• Cachexia
• Cancer Cachexia

Intervention

Drug:
• RC-1291 HCl

• Placebo

Locations

Country	Name	City	State
United States	Comprehensive Blood & Cancer Center	Bakersfield	California
United States	Center for Cancer and Blood Disorders	Bethesda	Maryland
United States	PAB Clinical Research	Brandon	Florida
United States	Charleston Cancer Center	Charleston	South Carolina
United States	South Carolina Oncology Associates	Columbia	South Carolina
United States	Hematology Oncology Consultants, Inc.	Columbus	Ohio
United States	Pacific Oncology & Hematology Associates	Encinitas	California
United States	Pacific Oncology and Hematology Associates	Encinitas	California
United States	Advanced Medical Research Institute	Fresno	California
United States	University of Texas Medical Texas	Galveston	Texas
United States	Palo Verde Hematology Oncology Ltd.	Glendale	Arizona
United States	South Carolina Cancer Specialists	Hilton Head Island	South Carolina
United States	Kenmar Clinical Research	Los Angeles	California
United States	Kenmar Research Institute	Los Angeles	California
United States	Melbourne Internal Medicine Associates	Melbourne	Florida
United States	Osler Medical, Inc./ Osler Clinical Research	Melbourne	Florida
United States	Sant Chawla, Inc.	Santa Monica	California
United States	Multicare Health System	Tacoma	Washington
United States	Bay Area Oncology	Tampa	Florida

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