Niraparib is a potent and highly selective PARP-1/-2 inhibitor. The primary objective of this trial is to evaluate the pharmacokinetic (PK) properties of ZL-2306 (niraparib) and its metabolite M1 in patients from Mainland China with ovarian cancer, following a single and multiple oral administration of the study drug at the indicated dose (300mg, 200mg or 100mg), once a day.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
About 30 subjects will be enrolled to the study, and randomised into 300mg, 200mg and 100mg dose groups (about 10 subjects per group). All subjects will be randomised into indicated dose group (300mg, 200mg or 100mg) at the first day of the first cycle. A single administration of ZL-2306 (niraparib) will be given to the subjects at indicated dose.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Haerbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Hunan Cancer Hospital
Changsha, Hunan, China
Maximum plasma drug concentration (Cmax)
Time frame: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Time to reach Cmax (Tmax)
Time frame: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Terminal rate constant (λz)
Time frame: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Elimination half-life (t1/2)
Time frame: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Area under the plasma concentration-time curve from time zero to 24hrs (AUC (0-24))
Time frame: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Area under the plasma concentration-time curve from time zero to time of last measurable concentration (AUC(0-t)) and from zero to infinity (AUC0-∞)
Time frame: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Apparent total body clearance of the drug from plasma (CL/F)
Time frame: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Apparent volume of distribution (Vd/f)
Time frame: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Mean residence time (MRT)
Time frame: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Degree of fluctuation (DF)
Time frame: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
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Fudan University Shanghai Cnacer Center
Shanghai, Shanghai Municipality, China
The West China Second UniversityHospital of Sichuan University
Chengdu, Sichuan, China
Maximum plasma drug concentration at steady-state (Css max)
Time frame: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Time to reach Css max (Tss max)
Time frame: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Minimum plasma drug concentration at steady-state (Css min)
Time frame: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Area under the plasma concentration-time curve from time zero to the end of drug administration (AUCss)
Time frame: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Steady-state apparent total body clearance of drug from plasma (Clss/F)
Time frame: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Accumulation ratio following multiple drug administration (RAC)
Time frame: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
The plasma drug concentration before drug administration
Time frame: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days)
Number of participants with adverse events as assessed by CTCAE v4.0
Time frame: From the signing of ICF till the end of this study (30 days after the last administration of the study drug or the date to close the clinical trial database, whichever is earlier)