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

AbbVie

Status and phase

Completed

Phase 1

Conditions

Locally Advanced Rectal Cancer

Treatments

Radiation: radiation

Drug: capecitabine

Drug: veliparib

Study type

Interventional

Funder types

Industry

Identifiers

NCT01589419

M12-950

Details and patient eligibility

About

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).

Enrollment

32 patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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