A Study of Niraparib in Patients With Ovarian Cancer in Clinical Practice

Active, not recruiting

• Conditions: Ovarian Cancer
• Interventions: Drug: Niraparib

• Registration Number: NCT05021562
• Lead Sponsor: Takeda

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-24
• Study First Submitted QC: 2021-08-24
• Study First Posted: 2021-08-25
• Study Start: 2021-09-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-03-25
• Primary Completion: 2026-03-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 354

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Niraparib 200-300 milligrams (mg)	Niraparib	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Event of Myelosuppression	1 year	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.
Number of Participants with Adverse Event of Posterior Reversible Encephalopathy Syndrome	1 year	Number of participants with AE of posterior reversible encephalopathy syndrome will be reported.
Number of Participants with Adverse Event of Hypertension	1 year	Number of participants with AE of hypertension will be reported.
Number of Participants with Adverse Event of Secondary Malignant Tumors	1 year	Number of participants with AE of secondary malignant tumors will be reported.
Number of Participants with Adverse Event of Thromboembolism	1 year	Number of participants with AE of thromboembolism will be reported.
Number of Participants with Adverse Event of Interstitial Lung Disease	1 year	Number of participants with AE of interstitial lung disease will be reported.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Achieve or Maintain Any Best Overall Response Category in Population of Recurrent Ovarian Cancer Participants with Platinum-Sensitive Homologous Recombination Repair Defects	1 year	Percentage of participants who achieve or maintain any best overall response category best overall response in population of recurrent ovarian cancer participants with platinum-sensitive homologous recombination repair defects will be reported. Best overall response will be assessed with reference to the excerpts from Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Best overall response is defined as the level of best response in assessment with complete response (CR), partial response (PR), progressive disease (PD), stable disease (SD) and not evaluable (NE) during the observational period.
Number of Participants who Experienced Exacerbation Assessed by Investigator during the Study	1 year	Exacerbation is defined as death or worsened symptom or disease assessed by investigator through tumor assessments, tumor marker assessments, and clinical assessments.

Trial Locations

Locations (1)

Takeda Selected Site; 🇯🇵 Tokyo, Japan