Fluzoparib is an oral potent, selective PARP-1 and PARP-2 inhibitor. The objective of this study will be to investigate the safety and tolerability of Fluzoparib Capsule when given orally to Chinese patients with advanced solid malignancies. In addition, the pharmacokinetic profile, MTD (if possible) and efficacy of Fluzoparib will be investigated.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
79
Fluzoparib either at 10,20,40,80,120mg ....., capsule oral.
No.307 Hospital, Academy of Military Medical Sciences
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
The maximum-tolerated dose (MTD) will be defined as the maximum dose level at which no more than one subject out of three experiences has a dose-limiting toxicity (DLT) upon completing one treatment cycle.
Time frame: 4 weeks
Evaluation of pharmacokinetic parameter of Fluzoparib: Cmax
Time frame: 4 weeks
Evaluation of pharmacokinetic parameter of Fluzoparib: Tmax
Time frame: 4 weeks
Evaluation of pharmacokinetic parameter of Fluzoparib: t1/2
Time frame: 4 weeks
Evaluation of pharmacokinetic parameter of Fluzoparib: AUC
Time frame: 4 weeks
Preliminary antitumor activity for the regimen, objective response rate(ORR)
To evaluate ORR 8 weeks after the initiation of Fluzoparib
Time frame: 8 weeks
Number of participants with adverse events.
Number of Participants with treatment related Adverse Events as Assessed by CTCAE v4.0
Time frame: 8 weeks
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