Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase I Study of ABT-888 in Combination With Oxaliplatin and Capecitabine in Advanced Solid Tumors
This phase I trial is studying the side effects and the best dose of veliparib when given together with capecitabine and oxaliplatin in treating patients with advanced solid tumors. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving veliparib together with capecitabine and oxaliplatin may kill more tumor cells.
PRIMARY OBJECTIVES:
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
tumors.
SECONDARY OBJECTIVES:
I. To evaluate the pharmacokinetics of ABT-888, oxaliplatin, and capecitabine when
administered concomitantly.
II. To evaluate the safety and tolerability of the ABT-888 in combination with capecitabine
and oxaliplatin.
III. To assess for evidence of anti-tumor activity with this combination, per tumor
measurements using RECIST criteria, in these patients.
TERTIARY OBJECTIVES:
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.
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Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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