Trials / Completed
CompletedNCT03271554
Treatment Registry of Alectinib in Anaplastic Lymphoma Kinase (ALK)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer in Korea
Treatment Registry of Alecensa in Korean Patients With Anaplastic Lymphoma Kinase (ALK)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 355 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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 adverse events and any other factors affecting safety and effectiveness of the new drug so that the regulatory authority can manage the marketing approval properly.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Alectinib | According to local labeling the recommended dose of alectinib is 600 mg given orally, twice daily with food (total daily dose of 1200 mg). |
Timeline
- Start date
- 2017-11-09
- Primary completion
- 2021-05-28
- Completion
- 2021-05-28
- First posted
- 2017-09-05
- Last updated
- 2022-11-18
Locations
37 sites across 1 country: South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03271554. Inclusion in this directory is not an endorsement.