The Clinical Trial to Evaluate the Pharmacokinetics, Safety and Tolerability of ZL-2306 (Niraparib) in Patients With Ovarian Cancer

Sponsor
Zai Lab (Shanghai) Co., Ltd.
Study ID
NCT03551171
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ZL-2306 (niraparib) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Dec 19, 2017
Status verified
May 2018
Primary completion
May 3, 2018
Completion
Jul 10, 2018

Study Design

Enrollment
42 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ZL-2306 (niraparib)
    Subjects will be randomised into 100mg, 200mg, 300mg dose group at the first day of the first cycle.

Primary Outcome Measure

Maximum plasma drug concentration (Cmax) [ Time Frame: From pre-dose to day 1 of the 2nd cycle (each cycle is 28 days) ]

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