A Phase I Study of ABT-888 in Combination With Oxaliplatin and Capecitabine in Advanced Solid Tumors
I. To determine the dose limiting toxicities (DLTs) and the maximum tolerated dose (MTD) of
ABT-888 (veliparib) in combination with oxaliplatin and capecitabine in advanced solid
I. To evaluate the pharmacokinetics of ABT-888, oxaliplatin, and capecitabine when
II. To evaluate the safety and tolerability of the ABT-888 in combination with capecitabine
III. To assess for evidence of anti-tumor activity with this combination, per tumor
measurements using RECIST criteria, in these patients.
I. To assess the inhibition of poly(ADP-ribose) polymerase (PARP) in peripheral blood
mononuclear cells secondary to treatment with ABT-888.
II. To determine the pharmacokinetics of ABT-888 in combination with oxaliplatin and
capecitabine and the relation to treatment side effects.
OUTLINE: This is a dose-escalation study of veliparib.
Patients receive veliparib orally (PO) twice daily and capecitabine PO twice daily on 1-7
and 15-21, and oxaliplatin intravenously (IV) over 2 hours on days 1 and 15. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
Patients undergo blood and urine sample collection at baseline and periodically during study
for pharmacokinetic and poly (ADP-ribose) polymerase (PARP) inhibition studies.
After completion of study therapy, patients are followed up for 30 days.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum-tolerated (MTD) dose of veliparib in combination with oxaliplatin and capecitabine as assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
MTD defined as the dose level at which less than one-third of patients experience a dose-limiting toxicity (DLT).
University of Wisconsin Hospital and Clinics
United States: Food and Drug Administration
|University of Wisconsin Hospital and Clinics||Madison, Wisconsin 53792-0001|