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

NCT05734911 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 199

Last updated 2023-02-21

No results posted yet for this study

Summary

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.

Conditions

  • Ovarian Neoplasms

Interventions

DRUG

Niraparib

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.

Sponsors & Collaborators

  • Zhongda Hospital

    lead OTHER

Principal Investigators

  • Yang Shen, MD · Zhongda Hospital

Eligibility

Min Age
26 Years
Max Age
78 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2022-12-31
Completion
2023-02-07
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05734911 on ClinicalTrials.gov