Phase II Study to Evaluate Efficacy and Safety of RP101 in Combination With Gemcitabine

Phase 2

Terminated

• Conditions: Pancreatic Cancer
• Interventions: Drug: RP101; Drug: Gemcitabine (1000 mg/m2)

• Registration Number: NCT00550004
• Lead Sponsor: SciClone Pharmaceuticals

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-10-25
• Study First Submitted QC: 2007-10-25
• Study First Posted: 2007-10-26
• Primary Completion: 2009-08
• Status Verified: 2009-10
• Study Completion: 2009-10
• Last Update Submitted: 2011-06-06
• Last Update Posted: 2011-06-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	RP101	RP101 and Gemcitabine
Arm 1	Gemcitabine (1000 mg/m2)	RP101 and Gemcitabine
Arm 2	Gemcitabine (1000 mg/m2)	Placebo and Gemcitabine

Primary Outcome Measures

Name	Time	Method
Overall Survival	18 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (55)

Fundación Arturo López Pérez; 🇨🇱 Santiago, Chile

Centrum Medyczne MRUKMED; 🇵🇱 Rzeszów, Poland

Petz Aladár Megyei Oktató Kórház Orvostovábbképzo Egyetem Oktató-Továbbképzo Kórháza, Onkoradiológia; 🇭🇺 Gyor, Budapest, Hungary

Institutul Oncologic 'Prof. Dr. A. Trestioreanu'; 🇷🇴 Bucuresti, Romania

Spitalul Clinic Universitar de Urgenta; 🇷🇴 Bucuresti, Romania

Instituto Oncocenter; 🇵🇪 San Borja, Peru

Spitalul Clinic de Urgenta Floreasca; 🇷🇴 Bucuresti, Romania

Mount Vernon Hospital; 🇬🇧 Middlesex, England, United Kingdom

Hospital Nacional Guillermo Almenara Irigoyen; 🇵🇪 La Victoria, Peru

Institutul Clinic Fundeni; 🇷🇴 Bucuresti, Romania

Klinikum Region Hannover GmbH, Krankenhause Siloah; 🇩🇪 Hannover, Germany

Centro Integral Oncológico Clara Campal, Hospital de Madrid Norte-San Chinarro; 🇪🇸 Madrid, Spain

Klinikum rechts der Isar, Technische Universität München; 🇩🇪 München, Germany

Hospital Universitario Miguel Servet; 🇪🇸 Zaragoza, Spain

Instituto Nacional do Câncer; 🇧🇷 Rio de Janeiro, Brazil

Centre Hospitalier Départemental; 🇫🇷 La Roche sur Yon Cedex 9, France

Hospital Nacional Edgardo Rebagliati Martins; 🇵🇪 Lima, Peru

I Katedra Chirurgii Ogólnej i Klinika Chirurgii Gastroenterologicznej; 🇵🇱 Kraków, Poland

Instituto Valenciano de Oncología; 🇪🇸 Valencia, Spain

Hospital de Caridade de Ijuí; 🇧🇷 Ijuí, Brazil

Hospital Universitario Arnau de Vilanova, Servicio de Oncologia; 🇪🇸 Lérida, Spain

Hospital Militar; 🇨🇱 Santiago de Chile, Chile

Núcleo de Oncologia da Bahia; 🇧🇷 Salvador, Brazil

Maaslandziekenhuis; 🇳🇱 Sittard, Netherlands

Hôpital Gabriel Montpied; 🇫🇷 Clermont-Ferrand, France

Universitätsklinikum Dresden, Med. Klinik I; 🇩🇪 Dresden, Germany

Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Wojewódzki; 🇵🇱 Jelenia Góra, Poland

Hospital de Clínicas de Porto Alegre, Serviço de Oncologia; 🇧🇷 Porto Alegre, Brazil

Hospital 12 de Octubre, Oncology Service, Hospital Materno Infantil; 🇪🇸 Madrid, Spain

Centre Eugene Marquis, Service d'Oncologie Medicale; 🇫🇷 Rennes, France

Wojewódzki Szpital Specjalistyczny im Kopernika w Lodzi; 🇵🇱 Lódz, Poland

Hospital do Câncer-AC Camargo; 🇧🇷 São Paulo, Brazil

Mid Dakota Clinic; 🇺🇸 Bismarck, North Dakota, United States

University of Arizona Medical Center, Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States

University of California at San Francisco; 🇺🇸 San Francisco, California, United States

Lakeland Regional Cancer Center; 🇺🇸 Lakeland, Florida, United States

Integrated Community Oncology Network, LLC; 🇺🇸 Jacksonville, Florida, United States

Gabrail Cancer Center; 🇺🇸 Canton, Ohio, United States

Tower Research Foundation at Tower Oncology; 🇺🇸 Beverly Hills, California, United States

South Texas Oncology and Hematology, PA; 🇺🇸 San Antonio, Texas, United States

St. Luke's Cancer Center; 🇺🇸 Bethlehem, Pennsylvania, United States

Signal Point Clinical Research Center, LLC; 🇺🇸 Middletown, Ohio, United States

Providence Portland Medical Center; 🇺🇸 Portland, Oregon, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Utah Cancer Specialists; 🇺🇸 Salt Lake City, Utah, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

Hospital Italiano Regional del Sur; 🇦🇷 Bahía Blanca, Buenos Aires, Argentina

Medical College of Wisconsin, Froedtert Multi-Disciplinary Cancer Center; 🇺🇸 Milwaukee, Wisconsin, United States

Cancer Care Northwest; 🇺🇸 Spokane, Washington, United States

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

Fovárosi Önkormányzat Uzsoki utcai Kórháza; 🇭🇺 Budapest, Hungary

Fovárosi Önkormányzat Egyesített Szent István és Szent László Kórház-Rendelointézet; 🇭🇺 Budapest, Hungary

Debreceni Egyetem Orvos és Egészségtudományi Centrum, Onkológiai Tanszék; 🇭🇺 Debrecen, Hungary

Leicester Royal Infirmary, University Hospitals of Leicester NHS Trust; 🇬🇧 Leicester, England, United Kingdom