Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor; Apatinib is an oral selective VEGFR inhibitor. This open-label, dose finding phase I trial studies the tolerability and the best dose of Fluzoparib in combination with apatinib and paclitaxel and to see how well this three drugs work together in the treatment of patients with recurrent and metastatic gastric cancer who progress following first-line therapy. The safety and efficacy of fluzoparib in combination with apatinib and paclitaxel will be explored.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Fluzoparib either at 20,30,40mg twice daily,capsule oral.
Oral
Intravenous injection
The Affiliated Hospital of Military Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGDLT and safety: Adverse Events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, hematology, urinalysis.
DLT and safety defined by CTC version 4.0
Time frame: through study completion, an average of 6 months
Best of ORR
Time frame: through study completion, an average of 6 months
Overall Response Rate (ORR)
Time frame: through study completion, an average of 6 months
Disease Control Rate (DOR)
Time frame: through study completion, an average of 6 months
Time to Progression (TTP)
Time frame: From date of enrollment until the date of first objective progression, assessed up to 9 months
Progression Free Survival (PFS)
Time frame: From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, an average of 6 months
Maximum plasma concentration (Cmax)
Time frame: Up to 33 days
Terminal half life (t1/2)
Time frame: Up to 33 days
Area under the plasma concentration-time curve (AUC)
Time frame: Up to 33 days
Volume of distribution (V/F)
Time frame: Up to 33 days
Plasma Clearance (CL/F)
Time frame: Up to 33 days
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