A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT04517357
Phase
PHASE2
Status
Completed

Conditions

  • Relapsed Ovarian Cancer

Eligibility Criteria

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

Interventions

Study Details

This is a multicenter, randomized, open-label, 2-arm Phase 2 study to evaluate the efficacy and safety of Fluzoparib with Apatinib versus Fluzoparib alone, as treatment, in relapsed ovarian cancer patients. The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 2 portion of the study.

Key Dates

Start date
Oct 16, 2020
Status verified
Feb 2025
Primary completion
Nov 30, 2023
Completion
Nov 1, 2024

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Lead-in or Parallel， Fluzoparib+Apatinib
    Participants will receive Fluzoparib-Apatinib combination until progression
  • Active Comparator: Fluzoparib monotherapy
    Participants will receive Fluzoparib monotherapy until progression
  • Other: Exploratory cohort: Fluzoparib+Apatinib
    Participants who has previously received PARP inhibitor, will receive Fluzoparib-Apatinib combination until progression

Primary Outcome Measure

(Safety Lead-in) dose limited toxicity (DLT) of Fluzoparib+Apatinib in the first cycle [ Time Frame: up to 28 days ]