Phase II Study to Evaluate Efficacy and Safety of RP101 in Combination With Gemcitabine
RP101
Randomized, Double Blind, Placebo Controlled, Phase 2 Study Evaluating the Efficacy & Safety of RP101 or Placebo in Combination With Gemcitabine Administered as First-Line Treatment to Subjects With Unresectable, Locally Advanced, or Metastatic Pancreatic Adenocarcinoma
1 other identifier
interventional
153
13 countries
55
Brief Summary
This will be a Phase II, multicenter, randomized, double blind, placebo controlled, study of six 28-day treatment cycles for patients with locally advanced, unresectable, or metastatic pancreatic cancer. The study will be conducted at approximately 55 sites in the North American, Europe, and South America. Approximately 153 subjects will be enrolled in a randomization (ratio 2:1).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 pancreatic-cancer
Started Sep 2007
Shorter than P25 for phase_2 pancreatic-cancer
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 25, 2007
CompletedFirst Posted
Study publicly available on registry
October 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedJune 8, 2011
October 1, 2009
1.9 years
October 25, 2007
June 6, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
18 months
Secondary Outcomes (4)
Progression Free Survival
14 months
Evaluate the CA 19-9 levels
12 months
Compare changes in ECOG
12 months
Evaluate Safety of RP101
18 months
Study Arms (2)
Arm 1
ACTIVE COMPARATORRP101 and Gemcitabine
Arm 2
PLACEBO COMPARATORPlacebo and Gemcitabine
Interventions
Eligibility Criteria
You may qualify if:
- Subjects must be 18 years of age or older
- 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
You may not qualify if:
- Prior history of other malignant tumors
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (55)
University of Arizona Medical Center, Arizona Cancer Center
Tucson, Arizona, 85724, United States
Tower Research Foundation at Tower Oncology
Beverly Hills, California, 90211, United States
University of California at San Francisco
San Francisco, California, 94110, United States
Integrated Community Oncology Network, LLC
Jacksonville, Florida, 32256, United States
Lakeland Regional Cancer Center
Lakeland, Florida, 33805, United States
Mid Dakota Clinic
Bismarck, North Dakota, 58501, United States
Gabrail Cancer Center
Canton, Ohio, 44718, United States
Signal Point Clinical Research Center, LLC
Middletown, Ohio, 45042, United States
Providence Portland Medical Center
Portland, Oregon, 97231, United States
St. Luke's Cancer Center
Bethlehem, Pennsylvania, 18015, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
South Texas Oncology and Hematology, PA
San Antonio, Texas, 78207, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
University of Washington
Seattle, Washington, 98109-1023, United States
Cancer Care Northwest
Spokane, Washington, 99202, United States
Medical College of Wisconsin, Froedtert Multi-Disciplinary Cancer Center
Milwaukee, Wisconsin, 53226, 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
Related Publications (1)
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.
PMID: 21833720DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Manuel Hidalgo, MD, PhD
Centro Integral de Oncologia
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 25, 2007
First Posted
October 26, 2007
Study Start
September 1, 2007
Primary Completion
August 1, 2009
Study Completion
October 1, 2009
Last Updated
June 8, 2011
Record last verified: 2009-10