Effectiveness and Safety of Niraparib as First-line Maintenance Therapy for Ovarian Cancer: a Real-world Study

Sponsor
Zhongda Hospital
Study ID
NCT05734911
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
26 Years - 78 Years
Healthy Volunteers
Not accepted

Interventions

  • Niraparib — DRUG
    We did not set a fixed starting dose and strict medication standard,compared with a randomized controlled trial.In our study,enrolled patients received different oral doses of niraparib until disease progression, severe toxicity occurred, or death in reality. We were interested in the dose adjustment and duration of niraparib in real world.

Study Details

In order to explore the real situation of niraparib in clinical application more comprehensively and deeply, we conducted the first multicenter, real-world study in China. This large observational study used real-world data to assess the effectiveness and safety of niraparib as maintenance therapy in patients with advanced ovarian cancer (AOC) in China and investigated clinical factors associated with prolonged benefits of niraparib so as to achieve the maximum clinical benefit of patients.

Key Dates

Start date
Jan 1, 2019
Status verified
Feb 2023
Primary completion
Dec 31, 2022
Completion
Feb 7, 2023

Study Design

Enrollment
199 participants (actual)

Arms

  • Arm: patients with ovarian cancer (OC) received niraparib as first-line (1st-L) maintenance therapy
    This multi-center, observational, retrospective study collected real-world medical record data of patients with advanced ovarian cancer treated with niraparib as first-line maintenance therapy from fourteen hospitals in China. In reality, these patients received different oral doses of niraparib until disease progression, severe toxicity occurred, or death. A total of 199 patients were included in a centralized database ultimately with a median age of 57.0 years (range, 51.0-63.5 years).

Primary Outcome Measure

progression-free survival(PFS) [ Time Frame: up to 29 months ]

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