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

Phase 2

Completed

• Conditions: Cancer Cachexia
• Interventions: Drug: placebo; Drug: RC-1291

• Registration Number: NCT00378131
• Lead Sponsor: Helsinn Therapeutics (U.S.), Inc

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-18
• Study First Submitted QC: 2006-09-18
• Study First Posted: 2006-09-19
• Primary Completion: 2007-04
• Study Completion: 2007-04
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-30
• Last Update Posted: 2013-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	placebo	-
2	RC-1291	RC-1291 50mg
3	RC-1291	RC-1291 100mg

Primary Outcome Measures

Name	Time	Method
Body weight; Lean body mass; Functional performance	4 weeks

Trial Locations

Locations (17)

Charleston Cancer Center; 🇺🇸 Charleston, South Carolina, United States

Beth Israel Cancer Center; 🇺🇸 New York, New York, United States

Palo Verde Hematology Oncology, Ltd.; 🇺🇸 Glendale, Arizona, United States

Melbourne Internal Medicine Associates; 🇺🇸 Melbourne, Florida, United States

South Carolina Oncology Associates, PA; 🇺🇸 Columbia, South Carolina, United States

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States

South Carolina Cancer Specialists; 🇺🇸 Hilton Head Island, South Carolina, United States

Sant P. Chawla, MD; 🇺🇸 Santa Monica, California, United States

Virginia Cancer Institute; 🇺🇸 Richmond, Virginia, United States

Northwest Medical Specialties; 🇺🇸 Tacoma, Washington, United States

Center for Cancer and Blood Disorders; 🇺🇸 Bethesda, Maryland, United States

Michael E. DeBakey VA Medical Center; 🇺🇸 Houston, Texas, United States

San Diego Pacific Oncology & Hematology Associates; 🇺🇸 Encinitas, California, United States

Southwest Oncology Associates; 🇺🇸 Lafayette, Louisiana, United States

Chesapeake Oncology Hematology Associates, PA; 🇺🇸 Glen Burnie, Maryland, United States

Cancer Outreach Associates; 🇺🇸 Abingdon, Virginia, United States

Multicare Health System; 🇺🇸 Tacoma, Washington, United States