Ignite Creation Date:
2024-05-06 @ 3:23 AM
Last Modification Date:
2024-10-26 @ 11:32 AM
Study NCT ID:
NCT02271139
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2017-03-09
First Post:
2014-10-17
Brief Title:
Expanded Access Study of Alectinib for Participants With Anaplastic Lymphoma Kinase ALK-Rearranged Non-Small Cell Lung Cancer NSCLC After Disease Progression on or Intolerance to Prior ALK Tyrosine Kinase Inhibitor Therapy
Sponsor:
Genentech Inc
Organization:
Genentech Inc
Study Overview
Official Title:
An Open Label Multicenter Single-Arm Expanded Access Study of Alectinib for Patients With ALK-Rearranged Non-Small Cell Lung Cancer After Disease Progression on or Intolerance to Prior ALK Tyrosine Kinase Inhibitor Therapy
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label multicenter single-arm expanded access study designed to provide alectinib to participants with ALK-rearranged NSCLC after disease progression on or intolerance to prior ALK tyrosine kinase inhibitor TKI therapy Participants will receive alectinib until disease progression unacceptable toxicity withdrawal of consent patient or physician decision to discontinue treatment death alectinib becomes commercially available in the United States following approval of alectinib by the FDA or the Sponsor decides to close the trial whichever occurs first approximately 15 months
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