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

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

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).

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