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

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

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

No publications provided

Study ID Numbers:	RC-1291-206
Study First Received:	September 18, 2006
Last Updated:	January 16, 2007
ClinicalTrials.gov Identifier:	NCT00378131 History of Changes
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

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Weight Loss

Body Weight Changes
Cachexia
Emaciation

ClinicalTrials.gov processed this record on May 07, 2009