Fluzoparib With or Without Apatinib in Platinum-sensitive Relapsed Ovarian Cancer Previously Treated With PARPi

Sponsor
Guangxi Medical University
Study ID
NCT06161272
Phase
PHASE2
Status
Unknown

Conditions

  • Fallopian Tube Cancer
  • High Grade Serous Adenocarcinoma of Ovary
  • Ovarian Cancer
  • Primary Peritoneal Carcinoma

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a randomized, multicenter, two-arm, noncomparative, phase II study of fluzoparib with or without apatinib for maintenance therapy in PARPi-pretreated platinum-sensitive recurrent ovarian cancer. The primary objective is to evaluate median progression free survival of fluzoparib with or without apatinib.

Key Dates

Start date
Dec 10, 2023
Status verified
Nov 2023
Primary completion
Mar 10, 2025
Completion
Jan 10, 2026

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm1：Fluzoparib
    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 4 weeks is a treatment cycle.
  • Experimental: Arm2：Fluzoparib + apatinib
    Fluzoparib capsule: oral administration, 2 capsules/dose (100 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 4 weeks is a treatment cycle. Apatinib: oral administration, 1 tablet/dose (375 mg/tablet), once a day, it is recommended to take orally within 0.5h after breakfast, continuous administration. Every 4 weeks is a treatment cycle.

Primary Outcome Measure

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

Central Contacts

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