NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031210289

Registered date:31/08/2021

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedOvarian Cancer
Date of first enrollment13/09/2021
Target sample size300
Countries of recruitment
Study typeObservational
Intervention(s)

Outcome(s)

Primary Outcome1.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. 2.Number of Participants with Adverse Event of Hypertension Time Frame: 1 year Number of participants with AE of hypertension will be reported. 3.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. 4.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. 5.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. 6.Number of Participants with Adverse Event of Thromboembolism Time Frame: 1 year Number of participants with AE of thromboembolism will be reported.
Secondary Outcome1.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 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. 2.Number of Participants who Experienced Exacerbation Assessed by Investigator during the Study Time Frame: 1 year Exacerbation is defined as death or worsened symptom or disease assessed by investigator through tumor assessments, tumor marker assessments, and clinical assessments.

Key inclusion & exclusion criteria

Age minimumNot applicable
Age maximumNot applicable
GenderFemale
Include criteriaAn 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.
Exclude criteriaHas a history of hypersensitivity to any of the ingredients of this drug.

Related Information

Contact

Public contact
Name Trial Information Contact for Clinical
Address 1-1, Doshomachi 4-chome, Chuo-ku, Osaka Osaka Japan 540-8645
Telephone +81-6-6204-2111
E-mail smb.Japanclinicalstudydisclosure@takeda.com
Affiliation Takeda Pharmaceutical Company Limited
Scientific contact
Name Trial Information Contact for Clinical
Address 1-1, Doshomachi 4-chome, Chuo-ku, Osaka Osaka Japan 540-8645
Telephone +81-6-6204-2111
E-mail smb.Japanclinicalstudydisclosure@takeda.com
Affiliation Takeda Pharmaceutical Company Limited