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

Completed · Phase 1

Conditions studied: Locally Advanced Rectal Cancer

In brief

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).

Key facts

Study ID

NCT01589419

Run by

AbbVie (prior sponsor, Abbott)

People needed

32

Starts

2012-06-01

Expected to finish

2015-01-01

Last updated by the study team

2017-11-20

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Site Reference ID/Investigator# 99095 — Scottsdale, Arizona, United States
• Site Reference ID/Investigator# 68044 — Chicago, Illinois, United States
• Site Reference ID/Investigator# 112395 — Goshen, Indiana, United States
• Site Reference ID/Investigator# 68045 — Durham, North Carolina, United States
• Site Reference ID/Investigator# 68043 — Madison, Wisconsin, United States
• Site Reference ID/Investigator# 67882 — East Melbourne, Australia

Full record on ClinicalTrials.gov

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