This is a Phase 1 study to evaluate the tolerability, safety, pharmacokinetics and preliminary efficacy of single agent Veliparib in Japanese subjects with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Subjects will be given veliparib twice daily on Days 1-28 every 28 days orally.
Site Reference ID/Investigator# 128056
Hidaka-shi, Japan
Site Reference ID/Investigator# 129976
Hyōgo, Japan
Site Reference ID/Investigator# 128057
Tokyo, Japan
Dose-limiting toxicities of veliparib
Time frame: During the first cycle (28 days) of veliparib administration
Change in participant physical exam measurements
Blood pressure, pulse and body temperature
Time frame: Approximately 1 year
Change in participant clinical lab results
Hematology, Chemistry and Urinalysis
Time frame: Approximately 1 year
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 1 year
Preliminary tumor response
According to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1
Time frame: Participants will be followed for the duration of an expected average of 8 months.
Maximum observed plasma concentration (Cmax)
Maximum observed concentration, occurring at Tmax
Time frame: For 24 hours following veliparib dosing.
The time to Cmax (peak time, Tmax)
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)
Time frame: For 24 hours following veliparib dosing.
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