First-line Maintenance Treatment With Fluzoparib Plus Bevacizumab in Advanced BRCA Wild Type Ovarian Cancer

Sponsor
Sun Yat-sen University
Study ID
NCT06063070
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Fallopian-tube Cancer
  • High Grade Endometrioid Ovarian Cancer
  • High Grade Serous Adenocarcinoma of Ovary
  • Ovarian Cancer
  • Primary Peritoneal Cancer

Eligibility Criteria

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

Interventions

  • Fluzoparib Capsules — DRUG
    oral
  • Bevacizumab — DRUG
    Injectable solution

Study Details

This is an open-label, multi-center Phase II study of fluzoparib combined with bevacizumab for maintenance therapy after first-line platinum-containing chemotherapy in patients with BRCA wild-type advanced ovarian cancer. The primary objective is to evaluate median progression free survival of fluzoparib plus bevacizumab.

Key Dates

First listed
Oct 2, 2023
Start date
Oct 18, 2023
Status verified
Sep 2023
Primary completion
Jan 31, 2025
Completion
Oct 30, 2027

Study Design

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

Arms

  • Experimental: Fluzoparib + Bevacizumab
    Fluzoparib capsule: oral administration, 3 capsules/dose (150 mg/ dose), twice a day, in the morning and evening, before/after meals can be taken orally, it is recommended to take orally within 0.5h after breakfast and dinner, continuous administration. Every 3 weeks is a treatment cycle. Bevacizumab injection: intravenous, 15 mg/kg, every 3 weeks for a treatment cycle until disease progression or intolerable toxicity, up to a total of 15 months.

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: from the first drug administration up to 2 years ]

Central Contacts

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