Real-World Treatment Study of Koselugo (Selumetinib)
1 other identifier
observational
200
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2024
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2024
CompletedFirst Posted
Study publicly available on registry
April 11, 2024
CompletedStudy Start
First participant enrolled
June 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 30, 2031
April 30, 2026
April 1, 2026
7.3 years
April 8, 2024
April 29, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (1)
Descriptive analysis with the physician qualitative assessments by overall disease status of NF-1 and status of clinically significant PNs, respectively. - Improving - Progression - Stable
1 year
Eligibility Criteria
Patients treated with Koselugo (Selumetinib) under the approved label in South Korea.
You may qualify if:
- Patients treated with Koselugo (Selumetinib) under the approved label in South Korea
- Provision of signed and dated written informed consent by the patient or legally acceptable representative
You may not qualify if:
- Patients treated with Koselugo (Selumetinib) under the approved label in South Korea
- Provision of signed and dated written informed consent by the patient or legally acceptable representative
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (12)
Research Site
Busan, South Korea
Research Site
Chungcheongbuk-do, South Korea
Research Site
Daejeon, South Korea
Research Site
Gyeonggi-do, South Korea
Research Site
Incheon, South Korea
Research Site
Jeonnam, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Seoul, South Korea
Research Site
Wŏnju, South Korea
Research Site
Yangsan, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
AstraZeneca Clinical Study Information Center
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2024
First Posted
April 11, 2024
Study Start
June 15, 2024
Primary Completion (Estimated)
September 30, 2031
Study Completion (Estimated)
September 30, 2031
Last Updated
April 30, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.