Ignite Creation Date:
2024-05-06 @ 3:27 AM
Last Modification Date:
2024-10-26 @ 11:34 AM
Study NCT ID:
NCT02292550
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2014-11-12
Brief Title:
Study of Safety and Efficacy of LEE011 and Ceritinib in Patients With ALK-positive Non-small Cell Lung Cancer
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase IbII Study of the ALK Inhibitor Ceritinib in Combination With the CDK46 Inhibitor LEE011 in Patients With ALK-positive Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2019-07
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 was a Phase IbII study of the ALK inhibitor ceritinib in combination with the CDK46 inhibitor LEE011 in patients with ALK-positive non-small cell lung cancer
The purpose of the study was to determine the MTDRP2D of the LEE011 and ceritinib combination and evaluate whether the combination was safe and had beneficial effects in ALK-positive advanced non-small cell lung cancer patients
This trial did not progress to Phase II Trial population terminated before reaching Phase II
The purpose of the study was to determine the MTDRP2D of the LEE011 and ceritinib combination and evaluate whether the combination was safe and had beneficial effects in ALK-positive advanced non-small cell lung cancer patients
This trial did not progress to Phase II Trial population terminated before reaching Phase II
Detailed Description:
In Sep-2016 Novartis made a decision not to move into phase ll after the primary objective for this study was met Because the study never made it to phase ll the study phase has been changed from a phase lll to a phase l
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None