A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea

Status Recruiting

Clinical Trial 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).

Clinical Trial Description

The study is a post approval surveillance so there will be no comparator arm/drug nor blinding process. Dose/regimen should follow locally approved label and it could be adjusted as per the decision from treating physician during treatment period, under their routine clinical practice. Treatment duration is deemed to the decision from treating physician under their routine clinical practice, since this study is a post approval surveillance and to look for safety profiles happening under real world practice. There will be no intervention from Novartis regarding dose/regimen and treatment duration. This study will be completed after data collection of the last subject during the follow up period. The follow up period is recommended for up to 24 weeks after enrollment or up to the time of discontinuation of study drug (in case of early discontinuation) as per linical judgement of treating physician. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05703516
Study type	Observational
Source	Novartis
Contact	Novartis Pharmaceuticals
Phone	+41613241111
Email	novartis.email@novartis.com
Status	Recruiting
Phase
Start date	June 12, 2023
Completion date	October 31, 2024

View Details

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