Ignite Creation Date:
2024-05-06 @ 1:42 AM
Last Modification Date:
2024-10-26 @ 11:08 AM
Study NCT ID:
NCT01871805
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2013-05-28
Brief Title:
A Study of Alectinib CH5424802RO5424802 in Participants With Anaplastic Lymphoma Kinase ALK-Rearranged Non-Small Cell Lung Cancer NSCLC
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Phase III Study of the ALK Inhibitor CH5424802 RO5424802 in Patients With ALK-Rearranged Non-Small Cell Lung Cancer Previously Treated With Crizotinib
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This non-randomized open-label multicenter study will evaluate the safety and efficacy of alectinib in participants with ALK-rearranged non-small cell lung cancer who failed crizotinib treatment In Phase I cohorts of participants will receive escalating doses of alectinib orally twice daily In Phase II patients who failed crizotinib treatment will receive the recommended phase II dose
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None