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).
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01589419
Ages eligible for Study
18 Years to 99 Years
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT01589419
United States (5)
Site Reference ID/Investigator# 99095
Scottsdale, Arizona, United States, 85258
Site Reference ID/Investigator# 68044
Chicago, Illinois, United States, 60611
Site Reference ID/Investigator# 112395
Goshen, Indiana, United States, 46526
Site Reference ID/Investigator# 68045
Durham, North Carolina, United States, 27710
Site Reference ID/Investigator# 68043
Madison, Wisconsin, United States, 53792
Site Reference ID/Investigator# 67882
East Melbourne, Australia, 3002
View full eligibility
Tris trial is registered with FDA with number: NCT01589419. The sponsor of the trial is AbbVie (prior sponsor, Abbott) and it is looking for 32 volunteers for the current phase.
Official trial title: 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)
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