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A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea
Sponsor: Novartis Pharmaceuticals
Summary
This is an open label, prospective, multicenter, non-comparative study to assess the safety and effectiveness of Tabrecta® (Capmatinib) in real world setting. Also, this study is to fulfill the regulatory requirements as part of the RMP (Risk Management Plan) for Tabrecta® (Capmatinib), as requested by Korea Health Authority, MFDS (Ministry of Food and Drug Safety).
Official title: A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea; Open Label, Prospective, Multicenter, Post Approval Surveillance
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
OBSERVATIONAL
Enrollment
250
Start Date
2023-06-12
Completion Date
2026-10-31
Last Updated
2025-01-14
Healthy Volunteers
No
Conditions
Interventions
Capmatinib
There is no treatment allocation. Capmatinib will be prescribed by the physician as per locally approved label. Treatment duration depends on the decision of treating physician. No drug will be dispensed from Novartis
Locations (12)
Novartis Investigative Site
Daegu, Dalseo Gu, South Korea
Novartis Investigative Site
Suwon, Gyeonggi-do, South Korea
Novartis Investigative Site
Seoul, Korea, South Korea
Novartis Investigative Site
Seoul, Seocho Gu, South Korea
Novartis Investigative Site
Busan, South Korea
Novartis Investigative Site
Daejeon, South Korea
Novartis Investigative Site
Incheon, South Korea
Novartis Investigative Site
Jeollanam, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea