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Real-World Treatment Study of Koselugo (Selumetinib)

NCT ID: NCT06360406

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-15

Study Completion Date

2031-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Neurofibromatosis 1 Neurofibroma, Plexiform

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

3 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Busan, , South Korea

Site Status RECRUITING

Research Site

Chungcheongbuk-do, , South Korea

Site Status RECRUITING

Research Site

Daejeon, , South Korea

Site Status RECRUITING

Research Site

Gyeonggi-do, , South Korea

Site Status RECRUITING

Research Site

Incheon, , South Korea

Site Status RECRUITING

Research Site

Jeonnam, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status SUSPENDED

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status COMPLETED

Research Site

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Research Site

Wŏnju, , South Korea

Site Status RECRUITING

Research Site

Yangsan, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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AstraZeneca Clinical Study Information Center

Role: CONTACT

Phone: 1-877-240-9479

Email: [email protected]

Other Identifiers

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D1346R00009

Identifier Type: -

Identifier Source: org_study_id