Ovarian Cancer
Conditions
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.
Interventions
DRUGNiraparib
Niraparib capsules
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 Hypertension | 1 year | Number of participants with AE of hypertension 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 Interstitial Lung Disease | 1 year | Number of participants with AE of interstitial lung disease 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Japan
Contacts
STUDY_DIRECTORStudy Director
Takeda
Outcome results
None listed