An Open-Label Phase 1b Study of the Safety and Tolerability of Veliparib in Combination With Capecitabine and Radiation in Subjects With Locally Advanced Rectal Cancer (LARC)

Inclusion Criteria:

- Subject must be ≥ 18 years of age

- All subjects must have newly diagnosed, histologically proven adenocarcinoma of the
rectum

- All subjects must have an abdominal/pelvis computed tomography (CT ) scan or magnetic
resonance imaging (MRI) confirming no evidence of distant metastases

- Distal border of tumor < 12 cm from anal verge

- Subjects must have an Eastern Cooperative Oncology Group (ECOG) Performance Score of
0 to 2

- No prior treatment for LARC however prior treatments for other cancers are acceptable
as long as they are considered curative

Exclusion Criteria:

- Subject is an unsuitable candidate for TME surgery

- Subject has received anticancer therapy

- Subject has received prior radiation therapy

- Subject has had major surgery within 28 days prior to the first dose of study drug

- History of gastric surgery, vagotomy, bowel resection or any surgical procedure that
might interfere with gastrointestinal motility, pH or absorption