Spots Global Cancer Trial Database for PARP Inhibitor Oral Maintenance in Low-Risk Ovarian Cancer

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Trial Identification

Brief Title: PARP Inhibitor Oral Maintenance in Low-Risk Ovarian Cancer

Official Title: A Phase IV Open-label, Multicenter Study of Niraparib as Maintenance Therapy in BRCA Wild-type, Newly Diagnosed Advanced Ovarian Cancer Patients in Korea

Study ID: NCT05187208

Conditions

Epithelial Ovarian Cancer

Ovarian Cancer

Ovarian Cancer Stage III

Ovarian Cancer Stage IV

Interventions

Niraparib

Study Description

Brief 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.

Detailed Description: This study is a 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. The study will assess the effectiveness of progression-free survival (12 months PFS rate) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The subject will be treated up to three years or until disease progression as below: 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.