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

Purpose

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 virture 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 evalulate the safety and efficacy of RC-1291 HCl in cancer patients with anorexia and cachexia.

Condition	Intervention	Phase
Cancer Cachexia	Drug: RC-1291	Phase II

MedlinePlus related topics:

Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Sapphire Therapeutics, Inc.:

Primary Outcome Measures:

Body weight; Lean body mass; Functional performance

Estimated Enrollment:	36
Study Start Date:	September 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378131

Contacts


Contact: Karen M. Kumor, MD	908-203-6541	kkumor@sapphirethera.com

Locations


United States, Arizona
	Palo Verde Hematology Oncology, Ltd.	Recruiting
	Glendale, Arizona, United States, 85304
	Contact: Peeyush Khanna, PhD, CRC 602-978-6255 ext 602
	Principal Investigator: Amol Rakkar, MD

United States, California
	Sant P. Chawla, MD	Recruiting
	Santa Monica, California, United States, 90403
	Contact: Victoria Chua 310-552-9999 vikychua@aol.com
	Principal Investigator: Sant P. Chawla, MD
	San Diego Pacific Oncology & Hematology Associates	Recruiting
	Encinitas, California, United States, 92024
	Contact: Geanie H. Huynh, BS 760-452-3340 ghuynh@ucsd.edu
	Principal Investigator: Edward McClay, MD

United States, Florida
	Melbourne Internal Medicine Associates	Recruiting
	Melbourne, Florida, United States, 32901
	Contact: James Neel, MD 321-725-4500 ext 233
	Principal Investigator: James Neel, MD

United States, Maryland
	Center for Cancer and Blood Disorders	Recruiting
	Bethesda, Maryland, United States, 20817
	Contact: Natalie K. Bongiorno, RN 301-571-2016 nbongiorno@ccbdmd.com
	Principal Investigator: Ralph V. Boccia, MD
	Chesapeake Oncology Hematology Associates, PA	Recruiting
	Glen Burnie, Maryland, United States, 21061
	Contact: Kathleen Cascino, RN 410-761-9896 kcascino@bwmc.umms.org
	Contact: Kim Gummer 410-761-9896
	Principal Investigator: Jack J Hong, MD

United States, South Carolina
	South Carolina Oncology Associates, PA	Recruiting
	Columbia, South Carolina, United States, 29210
	Contact: Kate Corcoran 803-461-3000 kdowney@sconcology.net
	Principal Investigator: Rudolph L Wise, MD
	South Carolina Cancer Specialists	Recruiting
	Hilton Head Island, South Carolina, United States, 29926
	Contact: Becky McCunn 843-689-2895
	Principal Investigator: Gary W. Thomas, MD
	Charleston Cancer Center	Recruiting
	Charleston, South Carolina, United States, 29406
	Contact: Michele DeCandio, RN 843-576-1006 michele@charlestoncancer.com
	Principal Investigator: Charles Graham, MD

United States, Texas
	University of Texas Medical Branch	Recruiting
	Galveston, Texas, United States, 77555
	Contact: Linda Valencia-Stephens, RN 409-772-1164
	Principal Investigator: Avi B Markowitz, MD

United States, Virginia
	Virginia Cancer Institute	Recruiting
	Richmond, Virginia, United States, 23230
	Contact: Vicki Tolbert, RN 804-288-7159 vtolbert@vacancer.com
	Principal Investigator: Pablo M Gonzalez, MD
	Cancer Outreach Associates	Recruiting
	Abingdon, Virginia, United States, 24211
	Contact: Karen Taylor, RN 276-676-1863 ktaylor@canceroutreach.com
	Principal Investigator: Forrest Swan, MD

United States, Washington
	Multicare Health System	Recruiting
	Tacoma, Washington, United States, 98405
	Contact: Diane Miller, RN 253-403-5265 Diane.Miller@multicare.org
	Principal Investigator: Richard Shine, PharmD
	Northwest Medical Specialties	Recruiting
	Tacoma, Washington, United States, 98405
	Contact: Teri Christiansen, RN 253-428-8752
	Principal Investigator: Thomas Baker, MD

Sponsors and Collaborators

Sapphire Therapeutics, Inc.

Investigators


Study Director:	Karen M Kumor, MD	Sapphire Therapeutics, Inc.

More Information

Study ID Numbers:	RC-1291-206
First Received:	September 18, 2006
Last Updated:	January 16, 2007
ClinicalTrials.gov Identifier:	NCT00378131
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Body Weight

Signs and Symptoms

Weight Loss

Body Weight Changes

Anorexia

Cachexia

Emaciation

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Sapphire Therapeutics, Inc.
Information provided by:	Sapphire Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00378131