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

Stopped early · Phase 2

Conditions studied: Pancreatic Cancer

In brief

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).

Key facts

Study ID

NCT00550004

Run by

SciClone Pharmaceuticals

People needed

153

Starts

2007-09-01

Expected to finish

2009-10-01

Last updated by the study team

2011-06-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• University of Arizona Medical Center, Arizona Cancer Center — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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