Real-World Treatment Study of Koselugo (Selumetinib)

Neurofibromatosis 1 Clinical Trial

Official title:

Real-World Treatment Study of Koselugo (Selumetinib)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06360406
• Other study ID #: D1346R00009
• Status: Not yet recruiting
• Start date: June 1, 2024
• Est. completion date: September 30, 2031

Study information

• Verified date: April 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: September 30, 2031
• Est. primary completion date: September 30, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Neurofibroma
• Neurofibroma, Plexiform
• Neurofibromatoses
• Neurofibromatosis 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events (AEs) rate	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	1 year
Primary	Physeal dysplasia occurance rate	To assess the safety of the study drug for patients prescribed with the study drug under the approved indication(s) in Korea	1 year
Secondary	Descriptive analysis with the physician qualitative assessments by overall disease status of NF-1 and status of clinically significant PNs, respectively. - Improving - Progression - Stable	To assess the effectiveness of the study drug for patients prescribed with the study drug under the approved indication(s) in Korea	1 year