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A Study of Niraparib in Patients With Relapsed Ovarian Cancer

NCT04392102 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-08-29

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

ZL-2306(Niraparib）

The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count

Sponsors & Collaborators

  • Zai Lab (Shanghai) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Rutie Yin · West China Second University Hospital

  • Xiaohua Wu · Fudan University

  • Hong Zheng · Peking University Cancer Hospital & Institute

  • Ge Lou · Harbin Medical University

  • Lingying Wu · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  • Hongmin Pan · Sir Run Shaw Hospital, school of medicine, Zhejiang University

  • Zhongqiu Lin · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-04
Primary Completion
2021-04-08
Completion
2022-08-11

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04392102 on ClinicalTrials.gov