Clinical trial · Observational
Real-world Study of Niraparib Maintenance Treatment in Patients With Newly Diagnosed Ovarian Cancer
An Observational, Non-interventional Study of Niraparib Maintenance Treatment in Patients With Ovarian Cancer After Frontline Platinum-based Chemotherapy
NCT04986371CI-TRIAL-00053030RENI-1unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, single-arm, multi-center、non-interventional real-world study, which evaluate treatment pattern, safety and efficacy of Niraparib as first-line maintenance treatment for Chinese patient with newly diagnosed ovarian cancer , fallopian tube cancer, and primary peritoneal cancer in real world clinical practice.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Niraparib | Drug | Niraparib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Starting dose of Niraparib
- timeFrame
- up to 3 years
- description
- Record the starting dose of Niraparib in real clinical practice
- measure
- Percentage of patients who have taken dose adjustment and the reason of dose adjustment
- timeFrame
- up to 3 years
- description
- Record the percentage of patients who have taken dose adjustment and the reason of dose adjustment
- measure
- Percentage of patients who have taken dose discontinuation and the reason of dose discontinuation
- timeFrame
- up to 3 years
- description
- Record the percentage of patients who have taken dose discontinuation and the reason of dose discontinuation
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 18 years or older * Histologically confirmed epithelial ovarian cancer, carcinoma of fallopian tube or primary peritoneal carcinoma * Having received one line of platinum-based chemotherapy, and clinically CR or PR to this line of chemotherapy * Understand the protocol, and Written informed consent before any study-related procedure Exclusion Criteria: * Participating in other clinical trials at the same time * Having sever or uncontrolled diseases that will influence the study, according to the judgement of investigators * Having other malignant tumors (other than breast cancer with BRCA mutation) * Pregnancy or breast feeding, or planning a pregnancy during the study * Unable to visit on time * Patients who are allergic to the study drug or drug components
References
Publications (0)
Data not yet available
No reference posted for this study.