Real-World Treatment Study of Koselugo (Selumetinib)

Recruiting now

Conditions studied: Neurofibromatosis 1, Neurofibroma, Plexiform

In brief

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.

Key facts

Study ID

NCT06360406

Run by

AstraZeneca

People needed

200

Starts

2024-06-15

Expected to finish

2031-09-30

Last updated by the study team

2026-07-22

Who can join

Age: 3 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Research Site — Busan, South Korea (enrolling)
• Research Site — Chungcheongbuk-do, South Korea (enrolling)
• Research Site — Daejeon, South Korea (enrolling)
• Research Site — Gyeonggi-do, South Korea (enrolling)
• Research Site — Incheon, South Korea (enrolling)
• Research Site — Jeonnam, South Korea (enrolling)
• Research Site — Seoul, South Korea (enrolling)
• Research Site — Wŏnju, South Korea (enrolling)
• Research Site — Yangsan, South Korea (enrolling)
• Research Site — Seoul, South Korea
• Research Site — Seoul, South Korea
• Research Site — Seoul, South Korea

Full record on ClinicalTrials.gov

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