RecruitingNot Applicable

Real-World Treatment Study of Koselugo (Selumetinib)

South Korea200 participantsStarted 2024-06-15

Plain-language 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.

Who can participate

Age range3 Years – 99 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Adverse events (AEs) rate

Timeframe: 1 year

Physeal dysplasia occurance rate

Timeframe: 1 year

Trial details

NCT IDNCT06360406

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2031-09-30

Contact for this trial

AstraZeneca Clinical Study Information Center

1-877-240-9479 information.center@astrazeneca.com

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