Clinical trial · Observational
Real-World Treatment Study of Koselugo (Selumetinib)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neurofibroma, Plexiform | Plexiform Neurofibroma | ONTOLOGY_EXACT | 0.98 |
| Neurofibromatosis 1 | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Adverse events (AEs) rate
- timeFrame
- 1 year
- description
- 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
- measure
- Physeal dysplasia occurance rate
- timeFrame
- 1 year
- description
- To assess the safety of the study drug for patients prescribed with the study drug under the approved indication(s) in Korea
Secondary outcomes (1)
- measure
- Descriptive analysis with the physician qualitative assessments by overall disease status of NF-1 and status of clinically significant PNs, respectively. - Improving - Progression - Stable
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available