A Study for Post-Marketing Surveillance of Niraparib in the Treatment of Adult Participants for Approved Indications in South Korea

Ovarian Neoplasms Clinical Trial

Official title:

Post-Marketing Surveillance (Usage Results Study) of Niraparib in the Treatment of Adult Patients for Approved Indications in South Korea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04589039
• Other study ID #: Niraparib-5001
• Secondary ID: U1111-1257-0180
• Status: Recruiting
• Start date: March 16, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: November 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 purpose of this study is to estimate the cumulative incidence of all adverse events (AEs), including serious adverse events (SAEs), adverse event of special interest (AESI), among participants who have been administered niraparib as per the approved indications.

Description:

This is a long-term prospective, observational post-marketing surveillance study of niraparib in participants with ovarian cancer (including fallopian tube, or primary peritoneal cancer) who are in complete or partial response to first-line platinum-based chemotherapy or who had complete or partial response to 2 or more lines of platinum-based chemotherapy or who have been treated with 3 or more prior chemotherapy regimens with either: BRCA mutation irrespective of platinum sensitivity; or platinum-sensitive HRD positive. The study will assess the safety and effectiveness of niraparib for its approved indication with real-world setting in South Korea.

The study will enroll approximately 600 participants. The data will be collected prospectively at the study sites will be recorded into electronic case report forms (e-CRFs). All the participants will be assigned to a single observational cohort:

• Participants With Ovarian Cancer

The multi-center study will be conducted in South Korea. Data collection will be based on routinely scheduled and emergency visits during a 24-month surveillance period or until end of the study whichever occurs first after drug administration. The overall duration of the study will be approximately 6 years.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Monotherapy for the maintenance treatment of adult participants with ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.

2. Monotherapy for the maintenance treatment of adult participants with recurrent high-grade serous ovarian cancer (including fallopian tube, or primary peritoneal cancer) who are in a complete or partial response to 2 or more lines of platinum-based chemotherapy.

3. Monotherapy treatment of adult participants with recurrent ovarian, fallopian tube or primary peritoneal cancer who have been treated with three or more prior chemotherapy regimens with either a) BRCA mutation (irrespective of platinum sensitivity) or b) platinum-sensitive HRD positive.

Exclusion Criteria:

1. Treated with niraparib outside of the locally approved label in Korea.

2. Niraparib is contraindicated as per product label.

3. Participating in other clinical trials of cancer treatment.

Related Conditions & MeSH terms

• Ovarian Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Inje University Haeundae Paik Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with AEs, SAEs, and AESIs		Baseline up to 24 months
Secondary	Time-to-Treatment Discontinuation (TTD)	TTD is defined as the time interval from the date of initiation of treatment until discontinuation of treatment, or death due to any cause, whichever occurs first. Participants who have not discontinued treatment, or died, will be censored at the last known time that the participant was on treatment.	From the date of first dose administration until discontinuation or death due to any cause whichever occurs first (up to 24 months)
Secondary	Progression Free Survival (PFS)	PFS is defined as the time interval from the date of initiation of treatment until objectively documented disease progression, or death due to any cause, whichever occurs first. Participants who do not have disease progression, or have not died, will be censored at the last known time that the participant was progression-free. Progressive disease (PD) is defined as at least a 20 percent (%) increase in the sum of the longest diameter (LD) of lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. The determination of disease progression will be at the Investigators discretion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.	From the date of first dose administration until disease progression or death due to any cause whichever occurs first (up to 24 months)