A Clinical Study Conducted in Multiple Centers Evaluating Escalating Doses of Veliparib in Combination With Capecitabine and Radiation in Patients With Locally Advanced Rectal Cancer

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)

An open-label, Phase 1b, dose escalation study evaluating the safety and tolerability of the PARP inhibitor 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