Ignite Creation Date:
2024-05-06 @ 7:33 AM
Last Modification Date:
2024-10-26 @ 11:49 AM
Study NCT ID:
NCT02554591
Status:
TERMINATED
Last Update Posted:
2018-03-05
First Post:
2015-09-08
Brief Title:
Genomic Landscape of Ceritinib
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
Retrospective Analysis of Genomic Landscape of ALK Positive NSCLC Prior to Ceritinib and at Disease Progression Following Ceritinib
Status:
TERMINATED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Changes in treatment plans affecting drug therapy choices
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators propose to conduct a retrospective study of single agent ceritinib in patients with previously untreated anaplastic lymphoma kinase ALK rearranged adenocarcinoma of the lung with the sole purpose of characterizing the genomic landscape before ceritinib and at the time of disease progression
Detailed Description:
Further improvements in therapy can only be achieved with a better understanding of the genomic landscape of ALK rearranged non-small cell lung cancer NSCLC specifically at the time of disease progression following treatment with ALK inhibitors Recently secondary ALK mutations L1196M and G1269A have been described in patients with acquired resistance to crizotinib A small subset of ALK positive lung cancer patients who progressed after treatment with ceritinib had tumors available for molecular analysis Secondary mutations found included G1202R F1174C and F1174V While this is interesting an unbiased genomic study exome or whole genome sequencing using massively parallel sequencing at the time of disease progression is critical to fully understand the clonal evolution and the molecular mechanisms underpinning treatment resistance To the best of the investigators knowledge such a study has not yet been reported
The investigators believe the time is ripe now to comprehensively characterize genomic alterations using massively parallel sequencing technology of ALK driven adenocarcinoma of the lung to fully understand the clonal heterogeneity before therapy and fully understand the clonal evolution and the molecular mechanisms underpinning treatment resistance A better understanding of genomic alterations through an unbiased comprehensive approach likely would lead to rationally designed therapy to augment response to ALK inhibitors
The investigators believe the time is ripe now to comprehensively characterize genomic alterations using massively parallel sequencing technology of ALK driven adenocarcinoma of the lung to fully understand the clonal heterogeneity before therapy and fully understand the clonal evolution and the molecular mechanisms underpinning treatment resistance A better understanding of genomic alterations through an unbiased comprehensive approach likely would lead to rationally designed therapy to augment response to ALK inhibitors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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