Fluzoparib is an oral potent, selective poly-ADP ribose polymerase-1 (PARP-1) and PARP-2 inhibitor; Apatinib is an oral selective vascular endothelial growth factor receptor (VEGFR) inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best dose of fluzoparib in combination with apatinib and to see how well these two drugs work together in the treatment of patients with recurrent ovarian cancer or triple negative breast cancer. The safety and efficacy of fluzoparib in combination with apatinib will be explored. Both dose escalation and dose expansion parts are included in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
98
Fluzoparib either at 40,60,80mg twice daily,capsule oral.
Apatinib at 250mg once daily, tablet oral
Beijing Cancer Hosptial
Beijing, Beijing Municipality, China
The type and incidence of adverse events [safety and tolerability]
Adverse events defined according to Common Terminology for Adverse Events (CTCAE) v4.03
Time frame: From screening up to 28 days after end of treatment
Objective Response Rate (ORR)
\[Complete response + Partial response (CR+PR)\] based on RECIST 1.1
Time frame: 24 months (approx) from the start of treatment
Disease Control Rate (DOR)
\[Complete response + Partial response + Stable disease (CR+PR+SD)\] based on RECIST 1.1
Time frame: 24 months (approx) from the start of treatment
Time to Progression (TTP)
The time from start of the treatment until radiographic disease progression or CA-125 progression specific for ovarian cancer patients
Time frame: From date of enrollment until the date of first objective progression or CA-125 progression (only for ovarian cancer patients), assessed up to 36 months
Overall Survival (OS)
Time from start of fluzoparib treatment until death due to any cause
Time frame: From Cycle 1, Day 1 until death or up to 48 months (approx)
Cmax
Maximum Plasma Concentration
Time frame: From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment
T1/2 (Half-life)
The time required for the plasma concentration of a drug to be reduced by 50%
Time frame: From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment
Area under curve (AUC)
Area under the plasma concentration-time curve
Time frame: Within the first 5 weeks from start of fluzoparib treatment
V/F
Volume of distribution
Time frame: From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment
CL/F
Plasma Clearance
Time frame: From the start of fluzoparib treatment alone to Cycle 2, Day 1 of combined treatment
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