A Post Approval Commitment Study on Tabrecta® (Capmatinib) in South Korea
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed 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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Capmatinib Participants will be treated with capmatinib as per locally approved label |
Other: 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
Other Names:
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Outcome Measures
Primary Outcome Measures
- Number of participants with adverse events (AEs) and serious adverse events (SAEs). [From date of first study dose to end of study, assessed up to approximately 28 weeks]
The number of participants with AEs and SAEs will be assessed
Secondary Outcome Measures
- Objective response rates (ORRs) assessed by investigator [Up to 24 weeks]
ORR is defined as the percentage of subjects with evidence of a confirmed complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 and as assessed by the investigator.
- Progression Free Survival (PFS) [Up to 24 weeks]
PFS defined as the time from first dose of study treatment until the first date of either objective disease progression or death due to any cause.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Signed informed consent must be obtained prior to participation in the study.
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Subject who are diagnosed as exon 14 skipping mutated NSCLC from tissue or plasma(ctDNA) sample analysis by treating physician (i.e. Any kind of diagnostic methods the institution currently has. Diagnostic modalities for research purpose would be also allowable.)
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Subject who plan to receive Tabrecta® (Capmatinib) as per locally approved label
Exclusion Criteria:
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Subject with contraindication according to the locally approved label
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Subject whose medical record is not accessible
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Subject who are not willing to provide informed consent
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CINC280AKR01