Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04589039
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 20, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda

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.

Condition or disease
Ovarian Neoplasms

Detailed 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance (Usage Results Study) of Niraparib in the Treatment of Adult Patients for Approved Indications in South Korea
Actual Study Start Date : March 16, 2020
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer
Drug Information available for: Niraparib

Group/Cohort
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.



Primary Outcome Measures :
  1. Percentage of Participants with AEs, SAEs, and AESIs [ Time Frame: Baseline up to 24 months ]

Secondary Outcome Measures :
  1. Time-to-Treatment Discontinuation (TTD) [ Time Frame: From the date of first dose administration until discontinuation or death due to any cause whichever occurs first (up to 24 months) ]
    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.

  2. Progression Free Survival (PFS) [ Time Frame: From the date of first dose administration until disease progression or death due to any cause whichever occurs first (up to 24 months) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04589039


Contacts
Layout table for location contacts
Contact: Takeda Contact 1-877-825-3327 medinfoUS@takeda.com

Locations
Layout table for location information
Korea, Republic of
Inje University Haeundae Paik Hospital Recruiting
Busan, Korea, Republic of, 48108
Sponsors and Collaborators
Takeda
Investigators
Layout table for investigator information
Study Director: Medical Director Takeda
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT04589039    
Other Study ID Numbers: Niraparib-5001
U1111-1257-0180 ( Registry Identifier: WHO )
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 20, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (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.
URL: https://vivli.org/ourmember/takeda/

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Drug Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders