RecruitingNCT06360406

Real-World Treatment Study of Koselugo (Selumetinib)


Sponsor

AstraZeneca

Enrollment

200 participants

Start Date

Jun 15, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

As part of a post-approval commitment, the Korean health authority requests a study to characterize safety and effectiveness in patients treated with Koselugo (Selumetinib), an oral selective inhibitor of MAPK kinase (MEK) 1 and 2, by physicians in routine clinical practice settings. This study is designed to assess the known safety profile or identify previously unsuspected adverse reactions and evaluate the effectiveness of Koselugo under conditions of routine daily medical practice in Korea. This study will provide information on the Korean patient population that is treated with the study drug.


Eligibility

Min Age: 3 YearsMax Age: 99 Years

Inclusion Criteria2

  • Patients treated with Koselugo (Selumetinib) under the approved label in South Korea
  • Provision of signed and dated written informed consent by the patient or legally acceptable representative

Exclusion Criteria2

  • Patients treated with Koselugo (Selumetinib) under the approved label in South Korea
  • Provision of signed and dated written informed consent by the patient or legally acceptable representative

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Locations(12)

Research Site

Busan, South Korea

Research Site

Chungcheongbuk-do, South Korea

Research Site

Daejeon, South Korea

Research Site

Gyeonggi-do, South Korea

Research Site

Incheon, South Korea

Research Site

Jeonnam, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Seoul, South Korea

Research Site

Wŏnju, South Korea

Research Site

Yangsan, South Korea

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NCT06360406


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