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
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:11/22/2017
Start Date:June 2012
End Date:January 2015

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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
We found this trial at
6
sites
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mi
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Scottsdale, AZ
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Chicago, IL
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Durham, NC
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East Melbourne,
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from
Goshen, IN
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from
Madison, WI
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