Finding studies
Finding studies
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Lead
National Cancer Institute (NCI)
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
