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| ID | Type | Description | Link |
|---|---|---|---|
| jRCT2031210289 | Registry Identifier | jRCT |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Niraparib | Drug | Niraparib capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
An individual who corresponds to any of the following:
Exclusion Criteria:
Has a history of hypersensitivity to any of the ingredients of this drug.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Takeda Selected Site | Tokyo | Japan |
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| Label | URL |
|---|---|
| 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. | View source |
| 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. | View source |
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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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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.
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| ID | Term |
|---|---|
| C545685 | niraparib |
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| 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. | 1 year |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |