Clinical trial · Observational
A Collaborative Trial of Niraparib to Evaluate Patients With Ovarian Cancer in the Expanded Access Program in Latin America
NCT05857397CI-TRIAL-00085856CONORactive not recruitingClinicalTrials.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)
Data from niraparib treatment is not available in real-world setting in Latin America. The present study aims to collect data from patients treated with niraparib within the Latin America Expanded Access Program (EAP) in clinical practice in Brazil and Argentina and who meet the eligibility criteria for this study, without additional intervention.
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 |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observational study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients treated within the EAPs with niraparib for ovarian cancer
- description
- This is an observational study; patients will not be exposed to clinical interventions different from those belonging to the standard of care.
- interventionNames
- Other: Observational study
Primary outcomes (1)
- measure
- Evaluate the safety profile
- timeFrame
- through study completion, an average of 36 months
- description
- To evaluate the safety profile, including dose modifications, of niraparib in patients with advanced ovarian cancer in response following first-line platinum-based chemotherapy treated in a real-world setting within the EAP.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with advanced OC in response following first line platinum-based chemotherapy who were treated with niraparib within the EAP in Argentina and Brazil; * Patients who have received at least one dose of niraparib in the EAP. Exclusion Criteria: * Patients without medical record available (lost, empty or irretrievable clinical information).
References
Publications (0)
Data not yet available
No reference posted for this study.