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

Ovarian Cancer Clinical Trial

Official title:

Zedula Special Drug Use Observational Study "Ovarian Cancer"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05021562
• Other study ID #: Niraparib-4001
• Secondary ID: jRCT2031210289
• Status: Recruiting
• Start date: September 13, 2021
• Est. completion date: March 31, 2026

Study information

• Verified date: October 2023
• Source: Takeda
• Contact: Takeda Contact
• Phone: +1-877-825-3327
• Email: medinfoUS[@]takeda.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Niraparib
Niraparib capsules

Locations

Country	Name	City	State
Japan	Takeda Selected Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of Participants with Adverse Event of Hypertension	Number of participants with AE of hypertension will be reported.	1 year
Primary	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
Primary	Number of Participants with Adverse Event of Interstitial Lung Disease	Number of participants with AE of interstitial lung disease will be reported.	1 year
Primary	Number of Participants with Adverse Event of Secondary Malignant Tumors	Number of participants with AE of secondary malignant tumors will be reported.	1 year
Primary	Number of Participants with Adverse Event of Thromboembolism	Number of participants with AE of thromboembolism will be reported.	1 year
Secondary	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.	1 year
Secondary	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

External Links

•   To obtain more information on the study, click here/on this link