Clinical trial · Observational
A Study of Niraparib in Patients With Ovarian Cancer in Clinical Practice
Zedula Special Drug Use Observational Study "Ovarian Cancer"
- 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)
The main aim of this study is to check for side effects from treatment with niraparib. The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study. During the study, participants with ovarian cancer will take capsules of niraparib (Zedula) once a day according to their clinic's standard practice. The study doctors will check for side effects from niraparib for 1 year after treatment starts.
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 |
|---|---|---|---|
| Niraparib | Drug | Niraparib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Niraparib 200-300 milligrams (mg)
- description
- Arm description: Niraparib 200 mg, capsules, orally, once daily. For adult participants weighing 77 kilograms (kg) or more and with platelet count 150,000/mcrL or higher before the first dose of this drug, niraparib 300 mg, capsules, orally, once daily.
- interventionNames
- Drug: Niraparib
Primary outcomes (6)
- measure
- Number of Participants with Adverse Event of Myelosuppression
- timeFrame
- 1 year
- description
- An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product. It does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with AE of myelosuppression will be reported.
- measure
- Number of Participants with Adverse Event of Hypertension
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: An individual who corresponds to any of the following: * Ovarian cancer patients after initial chemotherapy (maintenance therapy) * Patients with platinum antineoplastic drug sensitive recurrent ovarian cancer (maintenance therapy) * Recurrent ovarian cancer with platinum-sensitive homologous recombination repair defects. Exclusion Criteria: Has a history of hypersensitivity to any of the ingredients of this drug.
References
Publications (0)
Data not yet available