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NCT06873191Not yet recruiting

A Study to Learn More About Tukysa Once it is Out in the Korean Market

Post-Approval Safety Monitoring Program to Assess the Safety and Efficacy Profile of TUKYSA in Usual Practice

Source: ClinicalTrials.gov · Last updated 17 Nov 2025

Brief summary (registry, in English)

The objectives of the re-examination system in Korea is to re-confirm the clinical usefulness of the product through collecting, reviewing, identifying and verifying the safety and efficacy information about the product in general practice in Korea. This surveillance is conducted for preparing application material for re-examination under the Pharmaceutical Affairs Laws, the Regulations on Safety of Pharmaceuticals, etc. and the Re-examination Regulation for New Drugs and Others.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
600 (estimated)
First submitted
6 Mar 2025
Start date
1 Jan 2027
Primary completion date
1 May 2029
Lead sponsor
Pfizer
NCT number
NCT06873191

What you commit to

  • Study type: Observational
  • Planned participants: 600
  • From 1 Jan 2027 to the primary completion date, 1 May 2029
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Criteria the registry did not label

  • Inclusion criterias.
  • Patient who is treated with TUKYSA according to the current TUKYSA label for the approved indication.
  • Patient who is treated with TUKYSA for the first time.
  • Patient who is aged 18 or over.
  • Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
    • Exclusion criterias.
    • 1\. Patients to whom TUKYSA is contraindicated as per the local labeling Note: The summary for any patients who are violated in the inclusion/exclusion criteria (i.e. protocol violation case) will be separately done if collected and described in the separate section of the report.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.