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Niraparib and Bevacizumab Maintenance Therapy in Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With a PARP Inhibitor

NCT04734665 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2021-07-12

No results posted yet for this study

Summary

This study is phase II, open label, clinical trial to determine the efficacy of Niraparib re-treatment with Bevacizumab of assessment progression-free survival(6 months PFS rate) with platinum-sensitive recurrent ovarian cancer patients previously treated with a PARP inhibitor.

Conditions

  • Platinum-sensitive Recurrent Ovarian Cancer Patients Previously Treated With a PARP Inhibitor

Interventions

DRUG

Niraparib-Bevacizumab

Niraparib 200mg or 300mg (once daily\[QD\]) Bevacizumab 15mg/kg every 3 weeks (Q3W) \*The recommended starting dosage of niraparib is 200mg QD. For patients who weigh ≥77 kg and have baseline platelet count ≥150,000/μL, the recommended starting dosage is 300 mg QD.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY

  • Yonsei University

    lead OTHER

Principal Investigators

  • Jung Yun Lee · Severance Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-05
Primary Completion
2023-03-31
Completion
2024-03-31

Countries

  • South Korea

Study Locations

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Entities

Companies

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 NCT04734665 on ClinicalTrials.gov