Ignite Creation Date:
2024-05-06 @ 7:21 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02513667
Status:
TERMINATED
Last Update Posted:
2023-02-03
First Post:
2015-07-30
Brief Title:
Ceritinib in Combination With Stereotactic Ablative Radiation Metastatic Lung Adenocarcinoma
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Phase II Trial of Ceritinib in Combination With Stereotactic Ablative Radiation in ALK-rearranged Metastatic Lung Adenocarcinoma
Status:
TERMINATED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated after UTSW was informed by Novartis that further support for the study would not be provided
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to see if Ceritinib can target ALK in non-small cell lung cancer and slow down cancer growth and prevent it from spreading
Detailed Description:
This is an open-label two-cohort protocol designed to evaluate the activity of targeted therapy and SABR in ALK positive lung adenocarcinoma
Cohort A will evaluate the combination in ALK-inhibitor naïve patients Cohort B will evaluate the combination in patients who have received treatment with one prior ALK inhibitor
Ceritinib will be administered to the patient until disease progression by RECIST 11 unacceptable toxicity withdrawal of consent or discontinuation of the trial for any other reason including death
The primary focus of this protocol is identifying response in ALK lung cancer patients Patients with Ventana assay and Vysis FISH probe positive tumors will be treated Evidence of ALK gene rearrangement will also be considered eligible for the trial
Primary Objective
Cohort A Superiority of ceritinib SABR median PFS compared to historical control of 10 months expected to be 20 months
Endpoint
Cohort A Median PFS defined as time from initiation of ceritinib until disease progression by RECIST 11 unacceptable toxicity withdrawal of consent or discontinuation of the trial for any other reason including death
Primary
Cohort B Superiority of ceritinib SABR median PFS compared to historical control of 7 months
Endpoint
Cohort B Median PFS defined as time from initiation of ceritinib until disease progression by RECIST 11 unacceptable toxicity withdrawal of consent or discontinuation of the trial for any other reason including death
Secondary
Report Overall survival Overall survival
Report Time to 2nd SABR Time from start of systemic therapy to first day of second course of SABR
Report Time to 3rd SABR Time from start of therapy to first day of third course of SABR
Report proportion of patients CRPRstable disease at 6 and12 months Number of patients with CRPRstable disease for 6 and 12 months after initiation
Safety
-Demonstrate safety of ceritinib followed by SABR Describe toxicity and adverse events CTCAE v4 compared to historical controls
Cohort A will evaluate the combination in ALK-inhibitor naïve patients Cohort B will evaluate the combination in patients who have received treatment with one prior ALK inhibitor
Ceritinib will be administered to the patient until disease progression by RECIST 11 unacceptable toxicity withdrawal of consent or discontinuation of the trial for any other reason including death
The primary focus of this protocol is identifying response in ALK lung cancer patients Patients with Ventana assay and Vysis FISH probe positive tumors will be treated Evidence of ALK gene rearrangement will also be considered eligible for the trial
Primary Objective
Cohort A Superiority of ceritinib SABR median PFS compared to historical control of 10 months expected to be 20 months
Endpoint
Cohort A Median PFS defined as time from initiation of ceritinib until disease progression by RECIST 11 unacceptable toxicity withdrawal of consent or discontinuation of the trial for any other reason including death
Primary
Cohort B Superiority of ceritinib SABR median PFS compared to historical control of 7 months
Endpoint
Cohort B Median PFS defined as time from initiation of ceritinib until disease progression by RECIST 11 unacceptable toxicity withdrawal of consent or discontinuation of the trial for any other reason including death
Secondary
Report Overall survival Overall survival
Report Time to 2nd SABR Time from start of systemic therapy to first day of second course of SABR
Report Time to 3rd SABR Time from start of therapy to first day of third course of SABR
Report proportion of patients CRPRstable disease at 6 and12 months Number of patients with CRPRstable disease for 6 and 12 months after initiation
Safety
-Demonstrate safety of ceritinib followed by SABR Describe toxicity and adverse events CTCAE v4 compared to historical controls
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