This is a Phase 1 open-label, dose-escalation, safety and pharmacokinetic study of rucaparib administered twice daily (BID) to Japanese patients with a solid tumor who have failed previous standard treatment for their cancer. A recommended dose of rucaparib for Japanese patients will be determined in a dose-escalation portion and then further evaluated in a dose-expansion portion of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Rucaparib will be administered twice daily
Division of Medical Oncology, Hyogo Cancer Center
Akashi, Hyōgo, Japan
Department of Gynecologic Oncology, Saitama Medical Univeristy international Medical Center
Hidaka, Saitama, Japan
Department of Breast and Medical Oncology, National Cancer Center Hospital
Tsukiji, Tokyo, Japan
Number of participants with treatment-related Adverse Events (AEs) as assessed by CTCAE v4.03 as a measure of safety and tolerability
Time frame: From enrollment to completion of Part I (up to 12 months)
Number of participants with serious AEs as a measure of safety and tolerability
Time frame: From enrollment to completion of Part I (up to 12 months)
Number of participants with worsening laboratory values as a measure of safety and tolerability
Time frame: From enrollment to completion of Part I (up to 12 months)
Dose-limiting toxicities (DLTs) during Cycle 1 of treatment
Time frame: From enrollment to completion of Part I (up to 12 months)
Area under the plasma concentration versus time curve [AUC]
Time frame: From enrollment to completion of Part I (up to 12 months)
Peak Plasma Concentration [Cmax]
Time frame: From enrollment to completion of Part I (up to 12 months)
Total Plasma Clearance [CI/F]
Time frame: From enrollment to completion of Part I (up to 12 months)
Response to treatment according to RECIST Version 1.1
Time frame: From enrollment to primary completion of study (up to 3 years)
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