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PARP Inhibitor Oral Maintenance in Low-Risk Ovarian Cancer

NCT05187208 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2022-01-26

No results posted yet for this study

Summary

This study is the phase IV, open-label, clinical trial to determine the efficacy of niraparib maintenance therapy in BRCA1/2 wild-type, advanced-stage, low-risk, primary ovarian cancer patients.

Conditions

  • Epithelial Ovarian Cancer
  • Ovarian Cancer
  • Ovarian Cancer Stage III
  • Ovarian Cancer Stage IV

Interventions

DRUG

Niraparib

Niraparib 200mg or 300mg (once daily \[QD\])\* \*The recommended starting dosage of niraparib is 200mg QD. For patients who weigh ≥77 kg and have baseline platelet count ≥150,000/μL, the recommended starting dosage is 300 mg QD.

Sponsors & Collaborators

  • Yonsei University

    collaborator OTHER

  • Asan Medical Center

    collaborator OTHER

  • Samsung Medical Center

    collaborator OTHER

  • Takeda

    collaborator INDUSTRY

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Jae-Weon Jae-Weon, MD, PhD · Seoul National University Hpospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2025-12-31
Completion
2025-12-31

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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 NCT05187208 on ClinicalTrials.gov