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

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