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

NCT05021562 | Completed

• 2 other identifiers: Niraparib-4001jRCT2031210289
• Study Type: observational
• Target: 354
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Outcome Measures

Primary Outcomes (6)

• Number of Participants with Adverse Event of Myelosuppression

  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.

  1 year

• Number of Participants with Adverse Event of Hypertension

  Number of participants with AE of hypertension will be reported.

  1 year

• Number of Participants with Adverse Event of Posterior Reversible Encephalopathy Syndrome

  Number of participants with AE of posterior reversible encephalopathy syndrome will be reported.

  1 year

• Number of Participants with Adverse Event of Interstitial Lung Disease

  Number of participants with AE of interstitial lung disease will be reported.

  1 year

• Number of Participants with Adverse Event of Secondary Malignant Tumors

  Number of participants with AE of secondary malignant tumors will be reported.

  1 year

• Number of Participants with Adverse Event of Thromboembolism

  Number of participants with AE of thromboembolism will be reported.

  1 year

Secondary Outcomes (2)

• 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

• Number of Participants who Experienced Exacerbation Assessed by Investigator during the Study

  1 year

Study Arms (1)

Niraparib 200-300 milligrams (mg)

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.

Drug: Niraparib

Interventions

Niraparib DRUG

Niraparib capsules

Niraparib 200-300 milligrams (mg)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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), or recurrent ovarian cancer with platinum-sensitive homologous recombination repair defects.

You may qualify if:

• 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.

You may not qualify if:

• Has a history of hypersensitivity to any of the ingredients of this drug.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Takeda Selected Site

Tokyo, Japan

Location

Related Links

• Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
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MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

niraparib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: August 25, 2021
• Study Start: September 13, 2021
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

JP (1)