This is a Phase 1, open-label, multicenter, dose escalation study evaluating the tolerability, safety, pharmacokinetics and preliminary efficacy of veliparib in combination with carboplatin and weekly paclitaxel in Japanese subjects with ovarian cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Veliparib will be given orally, twice daily on Days 1-21, every 21 days.
Carboplatin will be administered on Day 1 of each cycle, intravenously.
Paclitaxel will be administered on Days 1, 8, 15 of each cycle, intravenously.
Site Reference ID/Investigator# 128815
Kurume-shi,Fukuoka, Japan
Site Reference ID/Investigator# 128997
Morioka, Japan
Site Reference ID/Investigator# 128058
Nagaizumi-cho, Japan
Number of participants with Dose-limiting toxicities
Time frame: During the first cycle (21 days) of veliparib administration
Number of participants with adverse events
Collect all adverse events at each visit and assess according to National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03
Time frame: Approximately 5 months
Preliminary tumor response
According to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
Time frame: Participants will be evaluated for 5 months.
Maximum observed plasma concentration (Cmax) of Veliparib
Maximum observed concentration, occurring at Tmax
Time frame: For 24 hours following veliparib dosing.
The time to Cmax (peak time, Tmax) of Veliparib
The time at which maximum plasma concentration (Cmax) is observed.
Time frame: For 24 hours following veliparib dosing.
The area under the plasma concentration-time curve (AUC) of Veliparib
Time frame: For 24 hours following veliparib dosing.
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