Phase II Study to Evaluate Efficacy and Safety of RP101 in Combination With Gemcitabine
NCT ID: NCT00550004
Last Updated: 2011-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
153 participants
INTERVENTIONAL
2007-09-30
2009-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
TRIPLE
Study Groups
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Arm 1
RP101 and Gemcitabine
RP101
190 mg oral tablet
Gemcitabine (1000 mg/m2)
30 minute intravenous infusion
Arm 2
Placebo and Gemcitabine
Gemcitabine (1000 mg/m2)
30 minute intravenous infusion
Interventions
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RP101
190 mg oral tablet
Gemcitabine (1000 mg/m2)
30 minute intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Not previously treated with chemotherapy for Pancreatic Cancer
* ECOG performance status of 0 or 1
* Life expectancy \> 3 months
* Documentation of all sites of pancreatic disease within 28 days prior to randomization
* Adequate hematological, renal, and hepatic function
* Not pregnant or nursing
* Fertile subjects must practice a medically approved method of contraception
Exclusion Criteria
* Participation in another investigational study within 4 weeks prior to treatment start
* Major surgery within 14 days prior to treatment start
* Radiation treatment within 28 days prior to treatment start
* Uncontrolled cardiac atrial or ventricular arrhythmias
* Gastrointestinal tract disease such resulting in an inability to take oral medication
* Known to be seropositive for HIV, HBV, or HCV
* Uncontrolled cancer pain
18 Years
ALL
No
Sponsors
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SciClone Pharmaceuticals
INDUSTRY
Responsible Party
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Sciclone Pharmaceuticals, Inc.
Principal Investigators
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Manuel Hidalgo, MD, PhD
Role: STUDY_CHAIR
Centro Integral de Oncologia
Locations
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University of Arizona Medical Center, Arizona Cancer Center
Tucson, Arizona, United States
Tower Research Foundation at Tower Oncology
Beverly Hills, California, United States
University of California at San Francisco
San Francisco, California, United States
Integrated Community Oncology Network, LLC
Jacksonville, Florida, United States
Lakeland Regional Cancer Center
Lakeland, Florida, United States
Mid Dakota Clinic
Bismarck, North Dakota, United States
Gabrail Cancer Center
Canton, Ohio, United States
Signal Point Clinical Research Center, LLC
Middletown, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
St. Luke's Cancer Center
Bethlehem, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
South Texas Oncology and Hematology, PA
San Antonio, Texas, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
University of Washington
Seattle, Washington, United States
Cancer Care Northwest
Spokane, Washington, United States
Medical College of Wisconsin, Froedtert Multi-Disciplinary Cancer Center
Milwaukee, Wisconsin, United States
Hospital Italiano Regional del Sur
Bahía Blanca, Buenos Aires, Argentina
Hospital Británico de Buenos Aires
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Hospital Zonal General de Agudos San Roque
La Plata, Buenos Aires, Argentina
Hospital de Caridade de Ijuí
Ijuí, , Brazil
Hospital de Clínicas de Porto Alegre, Serviço de Oncologia
Porto Alegre, , Brazil
Instituto Nacional do Câncer
Rio de Janeiro, , Brazil
Núcleo de Oncologia da Bahia
Salvador, , Brazil
Hospital do Câncer-AC Camargo
São Paulo, , Brazil
Fundación Arturo López Pérez
Santiago, , Chile
Hospital Militar
Santiago, , Chile
Hôpital Gabriel Montpied
Clermont-Ferrand, , France
Centre Hospitalier Départemental
La Roche-sur-Yon, , France
Centre Eugene Marquis, Service d'Oncologie Medicale
Rennes, , France
Universitätsklinikum Dresden, Med. Klinik I
Dresden, , Germany
Klinikum Region Hannover GmbH, Krankenhause Siloah
Hanover, , Germany
Klinikum rechts der Isar, Technische Universität München
München, , Germany
Petz Aladár Megyei Oktató Kórház Orvostovábbképzo Egyetem Oktató-Továbbképzo Kórháza, Onkoradiológia
Gyor, Budapest, Hungary
Fovárosi Önkormányzat Egyesített Szent István és Szent László Kórház-Rendelointézet
Budapest, , Hungary
Fovárosi Önkormányzat Uzsoki utcai Kórháza
Budapest, , Hungary
Debreceni Egyetem Orvos és Egészségtudományi Centrum, Onkológiai Tanszék
Debrecen, , Hungary
Maaslandziekenhuis
Sittard, , Netherlands
Hospital Nacional Guillermo Almenara Irigoyen
La Victoria, , Peru
Hospital Nacional Edgardo Rebagliati Martins
Lima, , Peru
Instituto Oncocenter
San Borja, , Peru
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewódzki
Jelenia Góra, , Poland
I Katedra Chirurgii Ogólnej i Klinika Chirurgii Gastroenterologicznej
Krakow, , Poland
Wojewódzki Szpital Specjalistyczny im Kopernika w Lodzi
Lódz, , Poland
Centrum Medyczne MRUKMED
Rzeszów, , Poland
Institutul Clinic Fundeni
Bucharest, , Romania
Institutul Oncologic 'Prof. Dr. A. Trestioreanu'
Bucharest, , Romania
Spitalul Clinic de Urgenta Floreasca
Bucharest, , Romania
Spitalul Clinic Universitar de Urgenta
Bucharest, , Romania
Hospital Universitario Arnau de Vilanova, Servicio de Oncologia
Lleida, , Spain
Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro
Madrid, , Spain
Hospital 12 de Octubre, Oncology Service, Hospital Materno Infantil
Madrid, , Spain
Instituto Valenciano de Oncología
Valencia, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust
Leicester, England, United Kingdom
Mount Vernon Hospital
Middlesex, England, United Kingdom
Countries
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References
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Heinrich JC, Tuukkanen A, Schroeder M, Fahrig T, Fahrig R. RP101 (brivudine) binds to heat shock protein HSP27 (HSPB1) and enhances survival in animals and pancreatic cancer patients. J Cancer Res Clin Oncol. 2011 Sep;137(9):1349-61. doi: 10.1007/s00432-011-1005-1. Epub 2011 Jul 22.
Related Links
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SciClone Website
Other Identifiers
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SCI-RP-Pan-P2-001
Identifier Type: -
Identifier Source: org_study_id
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