Pancreatic Cancer Clinical Trial
— RP101Official title:
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
| Verified date | October 2009 |
| Source | SciClone Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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).
| Status | Terminated |
| Enrollment | 153 |
| Est. completion date | October 2009 |
| Est. primary completion date | August 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Health Services Research
| Country | Name | City | State |
|---|---|---|---|
| Argentina | 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 |
| Brazil | 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 | |
| Chile | Fundación Arturo López Pérez | Santiago | |
| Chile | Hospital Militar | Santiago de Chile | |
| France | Hôpital Gabriel Montpied | Clermont-Ferrand | |
| France | Centre Hospitalier Départemental | La Roche sur Yon Cedex 9 | |
| France | Centre Eugene Marquis, Service d'Oncologie Medicale | Rennes | |
| Germany | Universitätsklinikum Dresden, Med. Klinik I | Dresden | |
| Germany | Klinikum Region Hannover GmbH, Krankenhause Siloah | Hannover | |
| Germany | Klinikum rechts der Isar, Technische Universität München | München | |
| 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 | Petz Aladár Megyei Oktató Kórház Orvostovábbképzo Egyetem Oktató-Továbbképzo Kórháza, Onkoradiológia | Gyor | Budapest |
| Netherlands | Maaslandziekenhuis | Sittard | |
| Peru | Hospital Nacional Guillermo Almenara Irigoyen | La Victoria | |
| Peru | Hospital Nacional Edgardo Rebagliati Martins | Lima | |
| Peru | Instituto Oncocenter | San Borja | |
| Poland | Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewódzki | Jelenia Góra | |
| Poland | I Katedra Chirurgii Ogólnej i Klinika Chirurgii Gastroenterologicznej | Kraków | |
| Poland | Wojewódzki Szpital Specjalistyczny im Kopernika w Lodzi | Lódz | |
| Poland | Centrum Medyczne MRUKMED | Rzeszów | |
| Romania | Institutul Clinic Fundeni | Bucuresti | |
| Romania | Institutul Oncologic 'Prof. Dr. A. Trestioreanu' | Bucuresti | |
| Romania | Spitalul Clinic de Urgenta Floreasca | Bucuresti | |
| Romania | Spitalul Clinic Universitar de Urgenta | Bucuresti | |
| Spain | Hospital Universitario Arnau de Vilanova, Servicio de Oncologia | Lérida | |
| 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 | |
| United Kingdom | Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust | Leicester | England |
| United Kingdom | Mount Vernon Hospital | Middlesex | England |
| United States | St. Luke's Cancer Center | Bethlehem | Pennsylvania |
| United States | Tower Research Foundation at Tower Oncology | Beverly Hills | California |
| United States | Mid Dakota Clinic | Bismarck | North Dakota |
| United States | Gabrail Cancer Center | Canton | Ohio |
| United States | Baylor College of Medicine | Houston | Texas |
| United States | Integrated Community Oncology Network, LLC | Jacksonville | Florida |
| United States | Lakeland Regional Cancer Center | Lakeland | Florida |
| United States | Signal Point Clinical Research Center, LLC | Middletown | Ohio |
| United States | Medical College of Wisconsin, Froedtert Multi-Disciplinary Cancer Center | Milwaukee | Wisconsin |
| United States | Providence Portland Medical Center | Portland | Oregon |
| United States | Utah Cancer Specialists | Salt Lake City | Utah |
| United States | South Texas Oncology and Hematology, PA | San Antonio | Texas |
| United States | University of California at San Francisco | San Francisco | California |
| United States | University of Washington | Seattle | Washington |
| United States | Cancer Care Northwest | Spokane | Washington |
| United States | University of Arizona Medical Center, Arizona Cancer Center | Tucson | Arizona |
| Lead Sponsor | Collaborator |
|---|---|
| SciClone Pharmaceuticals |
United States, Argentina, Brazil, Chile, France, Germany, Hungary, Netherlands, Peru, Poland, Romania, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall Survival | 18 months | No | |
| Secondary | Progression Free Survival | 14 months | No | |
| Secondary | Evaluate the CA 19-9 levels | 12 months | No | |
| Secondary | Compare changes in ECOG | 12 months | No | |
| Secondary | Evaluate Safety of RP101 | 18 months | No |
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