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

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie (prior sponsor, Abbott)
• Treatments: Capecitabine; Veliparib

Criteria

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