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Real-World Treatment Study of Koselugo (Selumetinib)

RECRUITINGSponsored by AstraZeneca
Actively Recruiting
SponsorAstraZeneca
Started2024-06-15
Est. completion2031-09-30
Eligibility
Age3 Years – 99 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06360406

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

Age: 3 Years – 99 YearsHealthy volunteers accepted
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

Conditions3

CancerNeurofibroma, PlexiformNeurofibromatosis 1

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