A Phase 1 Study of ABT-888 in Combination With Carboplatin and Paclitaxel in Advanced Solid Malignancies
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)
I. To define the dose-limiting toxicity and other toxicities associated with the use of this
II. To obtain preliminary evidence of antitumor activity in patients treated with this
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
Recommended phase II dose (RP2D) for each stratum
The RP2D for each cohort will be defined by the study separately. Standard up & down dose-escalation scheme to determine the RP2D will be use, and toxicities will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Up to 4 weeks
University of Pittsburgh
United States: Food and Drug Administration
|University of Pittsburgh Cancer Institute||Pittsburgh, Pennsylvania 15213|
|City of Hope Medical Center||Duarte, California 91010|
|City of Hope||Duarte, California 91010|
|University of Pittsburgh||Pittsburgh, Pennsylvania 15261|
|Emory University||Atlanta, Georgia 30322|
|UC Davis Comprehensive Cancer Center||Sacramento, California 95817|
|University of Southern California||Los Angeles, California 90033|
|Penn State Milton S Hershey Medical Center||Hershey, Pennsylvania 17033|