Study on the use of Koselugo for treating Neurofibromatosis 1
Real-World Treatment Study of Koselugo (Selumetinib)
This study is testing how well Koselugo works and how safe it is for people with Neurofibromatosis 1 in everyday treatment settings in South Korea.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 3 Years to 99 Years |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | Selumetinib |
| Locations | 12 sites (Busan and 11 other locations) |
| Trial ID | NCT06360406 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and effectiveness of Koselugo (Selumetinib) in patients with Neurofibromatosis 1, specifically focusing on those treated in routine clinical practice settings in South Korea. It is part of a post-approval commitment by the Korean health authority to gather real-world data on the drug's performance. The study will assess known safety profiles and identify any previously unknown adverse reactions while providing insights into the treatment outcomes for the Korean patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with Neurofibromatosis 1 who are receiving Koselugo treatment as per the approved label in South Korea.
Not a fit: Patients who are not being treated with Koselugo or those outside the approved treatment criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of Koselugo's safety and effectiveness, leading to improved treatment strategies for patients with Neurofibromatosis 1.
How similar studies have performed: While this study is focused on real-world data collection, similar studies assessing the effectiveness of targeted therapies have shown promising results in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Busan and 11 other locations
- 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)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.