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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE
Enrollment
153
190 mg oral tablet
30 minute intravenous infusion
Overall Survival
Time frame: 18 months
Progression Free Survival
Time frame: 14 months
Evaluate the CA 19-9 levels
Time frame: 12 months
Compare changes in ECOG
Time frame: 12 months
Evaluate Safety of RP101
Time frame: 18 months
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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
...and 45 more locations