A Study of Niraparib in Patients With Relapsed Ovarian Cancer

Sponsor
Zai Lab (Shanghai) Co., Ltd.
Study ID
NCT04392102
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • ZL-2306(Niraparib） — DRUG
    The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count

Study Details

This is a Phase 2, open-label, single arm study to evaluate the safety and efficacy of niraparib in ovarian cancer patients who have received three or four previous chemotherapy regimens. Niraparib is an orally active PARP inhibitor. Niraparib will be administered once daily continuously during a 28-day cycle. Health-related quality of life will be measured by Eastern Cooperative Oncology Group performance status (ECOG). Safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), RECIST tumor assessments and safety laboratory values.

Key Dates

Start date
Aug 4, 2020
Status verified
Aug 2022
Primary completion
Apr 8, 2021
Completion
Aug 11, 2022

Study Design

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

Arms

  • Experimental: ZL-2306(Niraparib)
    The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count

Primary Outcome Measure

Objective Response Rate（ORR） [ Time Frame: Up to 3 years ]

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