Ignite Creation Date:
2024-05-06 @ 4:00 AM
Last Modification Date:
2024-10-26 @ 11:42 AM
Study NCT ID:
NCT02424617
Status:
COMPLETED
Last Update Posted:
2022-08-18
First Post:
2015-04-09
Brief Title:
A Study of BGB324Bemcentinib in Combination With Erlotinib in Patients With Non-Small Cell Lung Cancer
Sponsor:
BerGenBio ASA
Organization:
BerGenBio ASA
Study Overview
Official Title:
A Multi-Center Open-Label Phase I2 Study of BGB324Bemcentinib in Combination With Erlotinib in Patients With Stage IIIb or Stage IV Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2022-08
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:
A Phase I2 multi-center open-label study of BGB324 bemcentinib in combination with erlotinib in participants with Stage IIIb or Stage IV non-small cell lung cancer Bemcentinib is a potent selective small molecule inhibitor of Axl a surface membrane protein kinase receptor which is connected with poor prognosis and acquired resistance to therapy
Detailed Description:
This is a multi-center multi-arm open-label Phase I2 study that will be conducted at up to 10 clinical sites in the US
Up to approximately 40 participants with histologically- or cytologically-confirmed Stage IIIb or Stage IV non-small cell lung cancer will receive bemcentinib BGB324 as a single agent Run-in Cohortmono therapy or in combination with erlotinib Arms A B C
Run-in Arm to establish the safety and tolerability of bemcentinibBGB324 administered as a single agent bemcentinib will be administered at a loading dose of 600 mg on Day 1 and Day 2 of Cycle 1 followed by 200 mg daily thereafter After 6 participants have been dosed and safety established Arm A dose escalation arm will be opened to confirm the bemcentinib dose to be used in combination with erlotinib
In Arm A the dose of bemcentinib BGB324 will be escalated in a standard 33 fashion until an maximum tolerated dose MTD of the combination bemcentinib erlotinib is established The dose of bemcentinib to be investigated in arm B and C will be confirmed upon recommendation of a Safety Review Committee
Arm B and C will open in parallel and will investigate bemcentinib in combination with erlotinib
Up to approximately 40 participants with histologically- or cytologically-confirmed Stage IIIb or Stage IV non-small cell lung cancer will receive bemcentinib BGB324 as a single agent Run-in Cohortmono therapy or in combination with erlotinib Arms A B C
Run-in Arm to establish the safety and tolerability of bemcentinibBGB324 administered as a single agent bemcentinib will be administered at a loading dose of 600 mg on Day 1 and Day 2 of Cycle 1 followed by 200 mg daily thereafter After 6 participants have been dosed and safety established Arm A dose escalation arm will be opened to confirm the bemcentinib dose to be used in combination with erlotinib
In Arm A the dose of bemcentinib BGB324 will be escalated in a standard 33 fashion until an maximum tolerated dose MTD of the combination bemcentinib erlotinib is established The dose of bemcentinib to be investigated in arm B and C will be confirmed upon recommendation of a Safety Review Committee
Arm B and C will open in parallel and will investigate bemcentinib in combination with erlotinib
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