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

NCT04589039 | Completed

• 2 other identifiers: Niraparib-5001U1111-1257-0180
• Study Type: observational
• Target: 662
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Neoplasms

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with AEs, SAEs, and AESIs

  Baseline up to 24 months

Secondary Outcomes (2)

• Time-to-Treatment Discontinuation (TTD)

  From the date of first dose administration until discontinuation or death due to any cause whichever occurs first (up to 24 months)

• Progression Free Survival (PFS)

  From the date of first dose administration until disease progression or death due to any cause whichever occurs first (up to 24 months)

Study Arms (1)

Participants with Ovarian Cancer

Participants diagnosed with ovarian cancer (including fallopian tube or primary peritoneal cancer) who have been prescribed with niraparib for the first time in a real-world setting, and who are in a complete or partial response to first-line platinum-based chemotherapy or who had complete or partial response to 2 or more line of platinum-based chemotherapy or who have been treated with 3 or more prior chemotherapy regimens with either breast cancer susceptibility gene (BRCA) mutation (irrespective of platinum sensitivity) or platinum-sensitive homologous recombination deficiency (HRD) positive will be observed prospectively over 24-month period, or until treatment discontinuation, or until end of study, which occurs first.

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants who have been prescribed niraparib for the first time in a real-world setting as a monotherapy treatment for participants with recurrent ovarian, fallopian tube or primary peritoneal cancer.

You may qualify if:

• 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.
• 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.
• 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.

You may not qualify if:

• Treated with niraparib outside of the locally approved label in Korea.
• Niraparib is contraindicated as per product label.
• Participating in other clinical trials of cancer treatment.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Inje University Haeundae Paik Hospital

Busan, 48108, South Korea

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 19, 2020
• Study Start: March 16, 2020
• Primary Completion: September 11, 2024
• Study Completion: September 11, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

KR (1)