Ovarian CancerNCT05021562
A Study of Niraparib in Patients With Ovarian Cancer in Clinical Practice
An observational study of Ovarian Cancer, run by Takeda at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Niraparib
- Type of treatment
- Pill or oral medicine
- How many people
- 354 participants
- Where
- 1 siteJapan
- Study dates
- 13 Sep 2021to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Has a history of hypersensitivity to any of the ingredients of this drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Zedula Special Drug Use Observational Study "Ovarian Cancer"
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
- Being tested
- Niraparib
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NiraparibDrug
Niraparib capsules
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Niraparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Number of Participants with Adverse Event of Hypertension
Number of participants with AE of hypertension will be reported.
Measured: 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.
Measured: 1 year
Number of Participants with Adverse Event of Interstitial Lung Disease
Number of participants with AE of interstitial lung disease will be reported.
Measured: 1 year
Number of Participants with Adverse Event of Secondary Malignant Tumors
Number of participants with AE of secondary malignant tumors will be reported.
Measured: 1 year
Number of Participants with Adverse Event of Thromboembolism
Number of participants with AE of thromboembolism will be reported.
Measured: 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
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.
Measured: 1 year
Number of Participants who Experienced Exacerbation Assessed by Investigator during the Study
Exacerbation is defined as death or worsened symptom or disease assessed by investigator through tumor assessments, tumor marker assessments, and clinical assessments.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start13 Sep 2021
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 354 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021562
- Sponsor's protocol ID
- Niraparib-4001
- Other IDs
- jRCT2031210289
- Status last verified
- Apr 2026
- First submitted
- 24 Aug 2021
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zedula Special Drug Use Observational Study "Ovarian Cancer"
- ClinicalTrials.gov ID
- NCT05021562
- Acronym / sponsor ID
- Niraparib-4001
- Conditions
- Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 354 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Niraparib 200-300 milligrams (mg) | – | Drug: NiraparibArm 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Has a history of hypersensitivity to any of the ingredients of this drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NiraparibNiraparib capsules | Drug | Niraparib 200-300 milligrams (mg) |
Primary outcome
Number of Participants with Adverse Event of Myelosuppression
Time frame: 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 Hypertension
Time frame: 1 year
Number of participants with AE of hypertension will be reported.
Number of Participants with Adverse Event of Posterior Reversible Encephalopathy Syndrome
Time frame: 1 year
Number of participants with AE of posterior reversible encephalopathy syndrome will be reported.
Number of Participants with Adverse Event of Interstitial Lung Disease
Time frame: 1 year
Number of participants with AE of interstitial lung disease will be reported.
Number of Participants with Adverse Event of Secondary Malignant Tumors
Time frame: 1 year
Number of participants with AE of secondary malignant tumors will be reported.
Number of Participants with Adverse Event of Thromboembolism
Time frame: 1 year
Number of participants with AE of thromboembolism will be reported.
2 secondary outcomes
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
Time frame: 1 year
Number of Participants who Experienced Exacerbation Assessed by Investigator during the Study
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- 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.Link provided by the sponsor.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Takeda at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Event of Myelosuppression (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.