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Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)

Non-small Cell Lung Cancer Clinical Trial

Official title:
A Phase I/II Study of Ceritinib + Trametinib in Patients With Advanced ALK-Positive Non-Small Cell Lung Cancer (NSCLC)

Clinical Trial Summary

This is a phase I/II 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.

Clinical Trial Description

This was intended to be a phase I/II study of ceritinib and trametinib in Stage IIIB or IV ALK rearranged NSCLC. The phase I portion is a standard 3+3 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 (e.g., 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03087448
Study type Interventional
Source University of California, San Francisco
Contact
Status Terminated
Phase Phase 1
Start date September 9, 2017
Completion date April 30, 2022
View Details
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