A Phase 4 interventional study of Niraparib in Epithelial Ovarian Cancer, Ovarian Cancer and Ovarian Cancer Stage III, sponsored by Seoul National University Hospital. Not yet recruiting. Open to female participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-01-26.
Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Treatment
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.
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.
This study's planned enrollment of 102 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participant is eligible to participate if she is not pregnant (see Appendix 2), not breastfeeding, and at least one of the following conditions applies:
Exclusion Criteria:
Participant has a known additional malignancy that is progressing or has required active treatment within the past 2 years.
Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. breast carcinoma, cervical cancer in situ, endometrial carcinoma) that have undergone potentially curative therapy are not excluded.
Note: Participants with synchronous primary endometrial cancer or a past history of primary endometrial cancer that met the following conditions are not excluded: Stage not greater than IA: no more than superficial myometrial invasion.
BRCA1/2 wild-type, advanced-stage, low-risk, primary ovarian cancer patients (high-grade serous or high-grade endoemtrioid)
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.
Progression-free survival (12 month PFS rate)
To determine the clinical effectiveness of the study treatment assessed using progression free survival (12 months) according to RECIST v1.1 criteria (Investigator determined)
Time frame: 12 months
Progression-free survival
Time frame: 36 months
Overall survival (OS)
Time frame: 36 months
Time to second objective disease progression (PFS2)
Time frame: 36 months
Time to second subsequent treatment (TSST)
Time frame: 36 months
12 month PFS rate by homologous recombination deficiency (HRD) status
Time frame: 12 months
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital