Adult Solid Neoplasm Clinical Trial
Official title:
A Phase 1 Study of ABT-888 in Combination With Carboplatin and Paclitaxel in Advanced Solid Malignancies
This phase I trial is studying the side effects and best dose of veliparib when given together with carboplatin and paclitaxel in treating patients with advanced solid cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin and paclitaxel, 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 carboplatin and paclitaxel may help kill more tumor cells.
PRIMARY OBJECTIVES:
I. To determine the recommended dose for phase II studies of veliparib (ABT-888 ) that can
be administered in combination with carboplatin and paclitaxel in patients with advanced
solid malignancies. (Stratum I) II. To determine the recommended dose for phase II studies
of veliparib that can be administered in combination with carboplatin and paclitaxel in
patients with advanced solid malignancies that harbor a germline BRCA1/2 mutation. (Stratum
II) (added 04/07/09)
SECONDARY OBJECTIVES:
I. To define the dose-limiting toxicity and other toxicities associated with the use of this
combination.
II. To obtain preliminary evidence of antitumor activity in patients treated with this
combination.
III. To evaluate the pharmacokinetic parameters of veliparib, carboplatin, and paclitaxel
when administered as a combination.
IV. To conduct correlative science studies.
OUTLINE: This is a multicenter, dose-escalation study of veliparib. Patients are stratified
according to BRCA status (no [stratum I] vs yes [stratum II]).
Patients receive carboplatin intravenously (IV) over 30 minutes and paclitaxel IV over 3
hours on day 3 and veliparib orally (PO) twice daily on days 1-7 until the recommended phase
II dose is determined. Treatment repeats every 3 weeks for at least 6 courses in the absence
of disease progression or unacceptable toxicity.
Patients undergo peripheral blood mononuclear cell collection periodically for
pharmacokinetic and biomarker studies.
After completion of study treatment, patients are followed up for 4 weeks.
;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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