Ignite Creation Date:
2024-05-06 @ 9:49 AM
Last Modification Date:
2024-10-26 @ 12:20 PM
Study NCT ID:
NCT03087448
Status:
TERMINATED
Last Update Posted:
2022-12-27
First Post:
2017-02-10
Brief Title:
Ceritinib Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer NSCLC
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
A Phase III Study of Ceritinib Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer NSCLC
Status:
TERMINATED
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase III study of ceritinib and trametinib in Stage IIIB or IV anaplastic lymphoma kinase ALK rearranged non-small cell lung cancer NSCLC The Phase I portion will investigate the safety and tolerability of the combination of ceritinib and trametinib in ALK or ROS-1 rearranged NSCLC The Phase II portion will investigate the clinical efficiency of the combination of ceritinib and trametinib in 3 single arm cohorts ALKi ALK inhibitor naïve patients post-crizotinib progressed disease PD patients and PD second line ALK tyrosine kinase inhibitor TKI patients
Detailed Description:
This was intended to be a phase III study of ceritinib and trametinib in Stage IIIB or IV ALK rearranged NSCLC
The phase I portion is a standard 33 dose escalation study starting at dose level 1 and will be open to any patient with ALK-rearranged or ROS-1 rearranged NSCLC
The study was terminated before Phase II was initiated The study did not open Phase II for enrollment into the planned cohorts
Cohort A ALKi Naïve
Cohort B Post-crizotinib PD
Cohort C PD second line ALK TKI eg alectinib ceritinib PF-06463922 or - AP21163
Only participants in Phase 1 were enrolled
Patients may continue treatment for up to 24 months from the time of study entry and will receive 12 months of follow-up following completion of the drugs
The phase I portion is a standard 33 dose escalation study starting at dose level 1 and will be open to any patient with ALK-rearranged or ROS-1 rearranged NSCLC
The study was terminated before Phase II was initiated The study did not open Phase II for enrollment into the planned cohorts
Cohort A ALKi Naïve
Cohort B Post-crizotinib PD
Cohort C PD second line ALK TKI eg alectinib ceritinib PF-06463922 or - AP21163
Only participants in Phase 1 were enrolled
Patients may continue treatment for up to 24 months from the time of study entry and will receive 12 months of follow-up following completion of the drugs
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2017-01318 | REGISTRY | NCI Clinical Trials Reporting Program CTRP | None |