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

Официальное название

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

Обзор

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.

Подробное описание

The purpose of this study is to understand the safety of Tukysa (Tucatinib hemiethanolate) once it is out in the Korean market. Tukysa will be given to participants aged 18 or over in Republic of Korea.

Surveillance Design Patients with the approved indication who are treated with TUKYSA within the local label will be enrolled.

Adverse Events (AEs) will be collected in the usual practice during administration and for 28 days following cessation of TUKYSA, and ORR will be evaluated through radiographic imaging in the usual practice. The total follow-up period will not exceed 1 year.

Safety

Through the evaluation the safety profile of TUKYSA including important identified risks, Important potential risks, missing information, which are defined about TUKYSA in table2, will be examined. Drug safety is evaluated through the following items:

Efficacy Drug efficacy will be evaluated through the BOR. The ORR which is defined as the proportion of the subjects in the analysis population who have best response as CR or PR will be presented.

Surveillance for long-term use The follow-up period for each patient will vary according to tumor response, treatment of TUKYSA and others. Any patients who are treated with TUKYSA for more than or equal to 180 days including dose interruption will be evaluated for surveillance for long-term use.

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: From Day 1 through Day 7 after administration. Administration and for 28 days following. The total follow-up period will not exceed 1 year.]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06873191 · C4251017

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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