A Study to Survey Adults in South Korea With Cancer Who Receive PADCEV Injection

Официальное название

Use-result Surveillance for PADCEV Injection 20 mg and 30 mg (Enfortumab Vedotin) in South Korea

Обзор

Enfortumab vedotin (or PADCEV Injection) is a treatment for cancer in the bladder lining (urothelial cancer). PADCEV Injection is now available to treat this cancer. People in this study will be adults in South Korea with locally advanced or metastatic urothelial cancer. Metastatic means the cancer has spread to other parts of the body. During their care, the person's doctor will have prescribed PADCEV Injection and other medicines to treat their cancer. People in the study will be treated according to their clinic's standard practice. This study is about collecting information only. This study will survey people who know they are receiving PADCEV Injection. The aims of the study are to check outcomes of treatment with PADCEV and record any medical problems during the study. Once a doctor has prescribed PADCEV Injection, a person in the study will be observed for up to 48 weeks (about 1 year) after their first dose. During this time, a person's medical records will be reviewed to check for any medical problems and to follow the condition of their cancer. If a person in the study stops taking PADCEV Injection sooner than 48 weeks, records will be reviewed until 30 days (1 month) after each person's last dose of PADCEV Injection or until they start a different medicine for their cancer.

Вмешательства

• Препарат Enfortumab Vedotin
  Intravenous

Первичные конечные точки

• Number of patients with an Adverse Event [Срок оценки: Up to 48 weeks after the first administration of PADCEV]
• Number of patients with an adverse drug reaction (ADR) [Срок оценки: Up to 48 weeks after the first administration of PADCEV]
• Number of patients with a serious AE (SAE) [Срок оценки: Up to 48 weeks after the first administration of PADCEV]
• Number of patients with a serious ADR (SADR) [Срок оценки: Up to 48 weeks after the first administration of PADCEV]
• Number of patients with an unexpected AE (UAE) [Срок оценки: Up to 48 weeks after the first administration of PADCEV]
• Number of patients with an unexpected ADR (UADR) [Срок оценки: Up to 48 weeks after the first administration of PADCEV]
• Number of patients with an important risk [Срок оценки: Up to 48 weeks after the first administration of PADCEV]

Вторичные конечные точки (2)

• Overall survival [Срок оценки: Up to 48 weeks after the first administration of PADCEV]
• Progression free survival [Срок оценки: Up to 48 weeks after the first administration of PADCEV]

Критерии участия

Критерии включения

• Patients who receive treatment with PADCEV Injection, according to the approved local label.

Критерии исключения

• Patients with any contraindication for PADCEV Injection, according to the approved local label.
• Patients who receive or are going to receive any investigational medicine during the observation period.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 18 центров

• Site KR82001 — Goyang-si
• Site KR82012 — Suwon
• Site KR82008 — Suwon
• Site KR82007 — Jeollanam-do
• Site KR82013 — Jeonju
• Site KR82015 — Busan
• Site KR82010 — Busan
• Site KR82009 — Busan
• … и ещё 10 центров

Идентификаторы

NCT: NCT06011954 · 7465-PV-0001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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