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

Sponsor
Yonsei University
Study ID
NCT04734665
Phase
PHASE2
Status
Unknown

Conditions

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

Eligibility Criteria

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

Interventions

  • Niraparib-Bevacizumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jul 5, 2021
Status verified
Jul 2021
Primary completion
Mar 31, 2023
Completion
Mar 31, 2024

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: experimental
    Platinum-sensitive recurrent ovarian cancer patients previously treated with a PARP inhibitor, Non-mucinous

Primary Outcome Measure

progression-free survival(6 months PFS rate) [ Time Frame: 6 months ]

Central Contacts