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

Last updated: December 10, 2024
Sponsor: Takeda
Overall Status: Completed

Phase

N/A

Condition

Ovarian Cysts

Treatment

N/A

Clinical Study ID

NCT04589039
Niraparib-5001
U1111-1257-0180
  • Ages > 19
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 partialresponse to first-line platinum-based chemotherapy.

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

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

Exclusion

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.

Study Design

Total Participants: 662
Study Start date:
March 16, 2020
Estimated Completion Date:
September 11, 2024

Study 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.

Connect with a study center

  • Inje University Haeundae Paik Hospital

    Busan, 48108
    Korea, Republic of

    Site Not Available

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