Fluzoparib and Apatinib Versus Fluzoparib in Relapsed Ovarian Carcinoma Maintenance Treatment

Sponsor
Xiaohua Wu MD
Study ID
NCT05479487
Phase
PHASE2
Status
Unknown

Conditions

  • Relapsed Ovarian Cancer

Eligibility Criteria

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

Interventions

  • Fluzoparib+Apatinib — DRUG
    Fluzoparib 100mg bid+ Apatinib 375mg qd
  • Fluzoparib Monotherapy — DRUG
    Fluzoparib 150mg bid

Study Details

This study is a Phase II randomized, open label, controlled, multicenter study to access the effects and tolerability of fluzoparib combined with apatinib versus fluzoparib monotherapy for maintenance treatment in platinum-sensitive relapsed ovarian carcinoma (including patients previous treated with a PARP inhibitor).

Key Dates

First listed
Jul 29, 2022
Start date
Aug 1, 2022
Status verified
Jul 2022
Primary completion
Nov 1, 2023
Completion
Sep 1, 2026

Study Design

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

Arms

  • Experimental: Fluzoparib+Apatinib combination
  • Active Comparator: Fluzoparib Monotherapy

Primary Outcome Measure

Progression Free Survival (PFS) in previous PARP inhibitor treated relapsed ovarian cancer patients. [ Time Frame: Up to 2 years ]

Central Contacts