Veliparib in Combination With Gemcitabine and Intensity Modulated Radiation Therapy in Patients With Pancreatic Cancer

Gemcitabine will be administered by intravenous infusion of 1000 mg/m2 over 30 minutes on
days 1, 8, 15 of the cycle. Intensity modulated radiation therapy (IMRT) will be given to a
total dose of 36 Gy in 15 fractions (2.4 Gy per fraction, one fraction per day, 5 fractions
per week, Monday through Friday) beginning on day 1. Veliparib will be administered per a
dose escalation schema. The starting dose of veliparib is 20 mg BID based upon
safety/efficacy data available. Dose escalation will continue in 20 mg increments until the
maximum tolerated dose (MTD) is reached. Intra-patient dose escalation will not be allowed.

Inclusion Criteria:

- Patients with histopathological or cytological diagnosis of adenocarcinoma of the
pancreas, as well as those with high clinical suspicion of adenocarcinoma, which is
deemed locally advanced unresectable or borderline resectable as determined by a
pancreatic cancer surgeon and/or following evaluation by a GI oncology tumor board.

- Age 18 years or older

Exclusion Criteria:

- Patients who have had prior anti-cancer treatment for their disease

- Patients who are currently receiving any other investigational agents

- Metastatic disease

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to PARP [Poly (ADP-ribosome) polymerase] inhibitors or gemcitabine

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements