Study on the use of Koselugo for treating Neurofibromatosis 1
Official title: Real-World Treatment Study of Koselugo (Selumetinib)
Run by AstraZeneca · NCT06360406 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 3 Years to 99 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | Selumetinib |
| Locations | 12 sites (Busan and 11 other locations) |
| Status | Recruiting |
| Started | June 15, 2024 |
| Main results expected | September 30, 2031 |
| Study ends | September 30, 2031 |
| Registry record updated | August 25, 2026 |
| Trial ID | NCT06360406 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients who are not being treated with Koselugo or those outside the approved treatment criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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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
Show 6 more locations
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Research Site
Seoul, South Korea Recruiting -
Research Site
Wŏnju, South Korea Recruiting -
Research Site
Yangsan, South Korea Recruiting -
Research Site
Seoul, South Korea Suspended -
Research Site
Seoul, South Korea Completed -
Research Site
Seoul, South Korea Not yet recruiting
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Testing PAS-004 for adults with Neurofibromatosis Type 1 and plexiform neurofibromas
This study is testing a new medication called PAS-004 to see if it is safe and helps adults with Neurofibromatosis Type 1 and painful plexiform neurofibromas.
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Combination therapy to shrink plexiform neurofibromas in NF1 patients
This trial tests whether the drugs cabozantinib and selumetinib can be safely given together to see if they help shrink progressive or painful plexiform neurofibromas in adolescents and adults with NF1.
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Early selumetinib to try to prevent plexiform neurofibromas in young children with NF1
This trial will see if giving selumetinib to young children with NF1 who are at high risk can prevent or slow the development of plexiform neurofibromas.
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Real-world use of selumetinib for adult NF1 with inoperable plexiform neurofibromas
This registry-following study tests how well and safely selumetinib works in adults with NF1 who have symptomatic, inoperable PN.
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Combo therapy with selumetinib and trastuzumab deruxtecan for advanced pancreatic cancer
This phase 1/2 trial tests whether the combination of selumetinib and DS-8201a (trastuzumab deruxtecan) is safe and whether it can help people with unresectable or metastatic pancreatic ductal adenocarcinoma.
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Online program providing personalized NF1 care letters plus videos or peer navigator support for adults with low health literacy
This study will test whether giving adults with NF1 and low health literacy personalized care letters plus either short, plain-language videos or a call with a trained peer navigator helps them better understand NF1 symptoms and care before their primary care visit.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.