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Clinical Trials in South Korea / NCT06360406
Recruiting Observational

Real-World Treatment Study of Koselugo (Selumetinib)

NCT06360406 · tracked via the Priya Life Science South Korea tracker
Sponsor
AstraZeneca
Phase
Observational
Started
2024-06-15
Last updated
2026-08-25

Condition(s) studied

Neurofibromatosis 1Neurofibroma, Plexiform

Study 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

Sex
ALL
Min age
3 Years
Max age
99 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Adverse events (AEs) rate — 1 year
    To assess the safety (Adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs) of the study drug for patients prescribed with the study drug under the approved indication(s) in Korea
  • Physeal dysplasia occurance rate — 1 year
    To assess the safety of the study drug for patients prescribed with the study drug under the approved indication(s) in Korea

Trial sites (12)

FacilityCityRegionStatus
Research Site Busan South Korea Recruiting
Research Site Chungcheongbuk-do South Korea Recruiting
Research Site Daejeon South Korea Recruiting
Research Site Gyeonggi-do South Korea Recruiting
Research Site Incheon South Korea Recruiting
Research Site Jeonnam South Korea Recruiting
Research Site Seoul South Korea Suspended
Research Site Seoul South Korea Recruiting
Research Site Seoul South Korea Completed
Research Site Seoul South Korea Not Yet Recruiting
Research Site Wŏnju South Korea Recruiting
Research Site Yangsan South Korea Recruiting

More AstraZeneca trials in South Korea

Savolitinib vs. Sunitinib in MET-driven PRCC. Active, not recruiting
A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus Recruiting
A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations Active, not recruiting
Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer Active, not recruiting
Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT Recruiting

Other trials for the same condition

PAS-004 in Adults Who Have Neurofibromatosis Type 1 With Plexiform Neurofibromas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06360406 on ClinicalTrials.gov ↗ ← All trials in South Korea