Ignite Creation Date:
2024-05-06 @ 1:25 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01801111
Status:
COMPLETED
Last Update Posted:
2018-11-02
First Post:
2013-02-20
Brief Title:
A Study of Alectinib RO5424802 in Participants With Non-Small Cell Lung Cancer Who Have Anaplastic Lymphoma Kinase ALK Mutation and Failed Crizotinib Treatment
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-Label Non-Randomized Multicenter Phase III Trial of RO5424802 Given Orally to Non-Small Cell Lung Cancer Patients Who Have ALK Mutation and Who Have Failed Crizotinib Treatment
Status:
COMPLETED
Status Verified Date:
2018-10
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 open-label non-randomized multicenter Phase 12 study will evaluate the safety and efficacy of alectinib in participants with non-small cell lung cancer who have ALK mutation and failed crizotinib treatment In Part 1 cohorts of participants will receive escalating doses of alectinib orally twice daily In Part 2 participants will receive the recommended phase 2 dose RP2D of alectinib as determined in Part 1 Treatment will continue in Part 1 and Part 2 on the same dose until disease progression In Part 3 following disease progression participants without epidermal growth factor receptor EGFR mutation will be offered continued treatment with alectinib participants with EGFR mutations will be offered a combination of alectinib and erlotinib
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-004455-36 | EUDRACT_NUMBER | None | None |