A Study of Fluzoparib±Apatinib Versus Placebo Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on First-Line Platinum-Based Chemotherapy

Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Study ID
NCT04229615
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Fluzoparib; Apatinib — DRUG
    Drug: Fluzoparib Orally twice daily; Apatinib Orally once daily
  • Fluzoparib — DRUG
    Fluzoparib Orally twice daily
  • Placebo — DRUG
    Placebo

Study Details

This is a multicenter, randomized, blinded, 3-arm Phase 3 study to evaluate the efficacy and safety of Fluzoparib alone or with Apatinib versus Placebo, as maintenance treatment, in patients with Stage III or IV ovarian cancer. Patients must have completed first-line platinum based regimen with Complete Response (CR) or Partial Response (PR). The study contains a Safety Lead-in Phase in which the safety and tolerability of Fluzoparib+Apatinib will be assessed prior to the Phase 3 portion of the study.

Key Dates

Start date
Jun 2, 2020
Status verified
Apr 2022
Primary completion
Jun 30, 2023
Completion
Apr 1, 2024

Study Design

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

Arms

  • Experimental: Safety Lead-in, Doublet Arm
    Fluzoparib+Apatinib
  • Experimental: Single Arm
    Fluzoparib
  • Placebo Comparator: Placebo
    Placebo

Primary Outcome Measure

(Safety Lead-in) Incidence of ≥3 grade TRAEs [ Time Frame: up to 28 days after the last patient of the lead-in phase ]

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