Status:
COMPLETED
Treatment Registry of Alectinib in Anaplastic Lymphoma Kinase (ALK)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer in Korea
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
19+ years
Brief Summary
Alectinib was approved by the Ministry of Food and Drug Safety (MFDS) in Korea in Oct 2016. The purpose of this registry is to investigate and confirm the type and incidence of newly identified advers...
Eligibility Criteria
Inclusion
- \- Subjects who are administered alectinib at physician's discretion and fall into the approved indication in Korea.
Exclusion
- Hypersensitivity to alectinib or any ingredient of alectinib;
- Pregnant or lactating women;
- Pediatric subjects (age \</=18 years);
- Due to the presence of lactose, subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take alectinib.
Key Trial Info
Start Date :
November 9 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 28 2021
Estimated Enrollment :
355 Patients enrolled
Trial Details
Trial ID
NCT03271554
Start Date
November 9 2017
End Date
May 28 2021
Last Update
November 18 2022
Active Locations (37)
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1
Inje University Busan Paik Hospital
Busan, South Korea, 47392
2
Dong-A University Hospital
Busan, South Korea, 49201
3
Pusan National University Hospital
Busan, South Korea, 49241
4
Kosin University Gospel Hospital
Busan, South Korea, 49267