Overview

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