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Placebo Controlled, Randomized Safety and Efficacy Study of RC-1291 in Cancer Anorexia/Cachexia
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Protocol IDs
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Phase II
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Supportive care
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Active
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19 and over
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Pharmaceutical / Industry
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RC-1291-206
NCT00378131
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Trial Description
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 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. Eligibility 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.
- If female-pregnant, breast-feeding or of childbearing potential.
Trial Contact Information
Trial Lead Organizations/Sponsors Sapphire Therapeutics | Karen M Kumor, MD | | Study Director |
Trial Sites
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| U.S.A. |
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| Arizona |
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Glendale |
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| | | | | | | | | Palo Verde Hematology Oncology - Glendale |
| | | Peeyush Khanna, PhD, CRC |
Ph: 602-978-6255 Ext.602 |
| | | Amol Rakkar, MD | Principal Investigator |
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| California |
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Encinitas |
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| | | | San Diego Pacific Oncology and Hematology Associates, Incorporated - Encinitas |
| | | Geanie H. Huynh, BS |
Ph: 760-452-3340 |
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Email:
ghuynh@ucsd.edu |
| | | Edward McClay, MD | Principal Investigator |
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Santa Monica |
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| | | Sant P. Chawla, MD |
| | | Victoria Chua |
Ph: 310-552-9999 |
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Email:
vikychua@aol.com |
| | | Sant P. Chawla, MD | Principal Investigator |
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| Florida |
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Melbourne |
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| | | | Melbourne Internal Medicine Associates at Melbourne Cancer Center |
| | | James Neel, MD |
Ph: 321-725-4500 Ext.233 |
| | | James Neel, MD | Principal Investigator |
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| Maryland |
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Bethesda |
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| | | | Center for Cancer and Blood Disorders at Suburban Hospital |
| | | Natalie K. Bongiorno, RN |
Ph: 301-571-2016 |
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Email:
nbongiorno@ccbdmd.com |
| | | Ralph Vincent Boccia | Principal Investigator |
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Glen Burnie |
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| | | Chesapeake Oncology Hematology Associates at Tate Cancer Center |
| | | Kathleen Cascino, RN |
Ph: 410-761-9896 |
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Email:
kcascino@bwmc.umms.org |
| | | Kim Gummer |
Ph: 410-761-9896 |
| | | Jack J Hong, MD | Principal Investigator |
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| South Carolina |
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Charleston |
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| | | | Charleston Cancer Center |
| | | Michele DeCandio, RN |
Ph: 843-576-1006 |
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Email:
michele@charlestoncancer.com |
| | | Charles Graham, MD | Principal Investigator |
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Columbia |
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| | | South Carolina Oncology Associates, PA |
| | | Kate Corcoran |
Ph: 803-461-3000 |
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Email:
kdowney@sconcology.net |
| | | Rudolph L Wise, MD | Principal Investigator |
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Hilton Head Island |
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| | | South Carolina Cancer Specialists |
| | | Becky McCunn |
Ph: 843-689-2895 |
| | | Gary W. Thomas, MD | Principal Investigator |
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| Texas |
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Galveston |
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| | | | University of Texas Medical Branch |
| | | Linda Valencia-Stephens, RN |
Ph: 409-772-1164 |
| | | Avi B Markowitz, MD | Principal Investigator |
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| Virginia |
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Abingdon |
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| | | | Cancer Outreach Associates - Abingdon |
| | | Karen Taylor, RN |
Ph: 276-676-1863 |
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Email:
ktaylor@canceroutreach.com |
| | | Forrest Swan, MD | Principal Investigator |
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Richmond |
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| | | Virginia Cancer Institute - West End |
| | | Vicki Tolbert, RN |
Ph: 804-288-7159 |
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Email:
vtolbert@vacancer.com |
| | | Pablo M Gonzalez, MD | Principal Investigator |
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| Washington |
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Tacoma |
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| | | | MultiCare Regional Cancer Center at Tacoma General Hospital |
| | | Diane Miller, RN |
Ph: 253-403-5265 |
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Email:
Diane.Miller@multicare.org |
| | | Richard Shine, PharmD | Principal Investigator |
| | | Northwest Medical Specialties, PLLC - Tacoma |
| | | Teri Christiansen, RN |
Ph: 253-428-8752 |
| | | Thomas Baker, MD | Principal Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00378131
Information obtained from ClinicalTrials.gov on May 27, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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