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NCT06360406 Clinical Trial

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
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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