A Phase 1 interventional study of veliparib and capecitabine in Locally Advanced Rectal Cancer, sponsored by AbbVie (prior sponsor, Abbott). Completed at 6 sites in 2 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2017-11-20.
Sponsored by AbbVie (prior sponsor, Abbott) · Phase 1, Interventional, and Treatment
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).
1,762 studies on the registry are indexed under Rectal Neoplasms; 517 are open to participants now.
This study's enrollment of 32 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →AbbVie (prior sponsor, Abbott) is the lead sponsor of 215 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Veliparib on days 1-7, capecitabine and radiation on days 1-5
Drug: veliparib · Drug: capecitabine · Radiation: radiation
see arm description
Also known as: ABT-888
see arm description
Also known as: Xeloda
see arm description
Determine the maximum tolerated dose (MTD) and/or establish the recommended phase two dose (RPTD)
Time frame: From first study drug dose and at each weekly treatment visit until dose-limiting toxicities (DLT) observed or completion of dosing period (anticipated to be approximately 5 weeks).
Assess the safety (number of participants with adverse events and types of adverse events observed)
Time frame: From screening and ongoing at each weekly treatment visit through dosing period (anticipated to be approximately 5 weeks), prior to surgery and at the final visit.
Assess the tolerability (number of participants with adverse events and types of adverse events observed)
Time frame: From first study drug dose and ongoing at each weekly treatment visit, through completion of dosing period (anticipated to be approximately 5 weeks).
Assess the pharmacokinetic profile by area under the curve vs. dose of veliparib
Time frame: Multiple measurements over time points (0, .5, 1, 2, 3, 4, 6 hours post dose) Day 1, Day 2 and at the pre-dose time point on Day 5 and week 2 visit.
This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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AbbVie (prior sponsor, Abbott)