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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
see arm description
see arm description
see arm description
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
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.
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Site Reference ID/Investigator# 68043
Madison, Wisconsin, United States
Site Reference ID/Investigator# 67882
East Melbourne, Australia