Ignite Creation Date:
2024-05-06 @ 12:41 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01637597
Status:
UNKNOWN
Last Update Posted:
2016-07-21
First Post:
2012-06-28
Brief Title:
Crizotinib Efficacy In Non-Small Cell Lung Cancer Patients With Anaplastic Lymphoma Kinase Translocation
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
An Exploratory Study Of Crizotinib Efficacy In Non-Small Cell Lung Cancer Patients With Anaplastic Lymphoma Kinase Translocation Determined By Different Molecular Diagnostic Methods
Status:
UNKNOWN
Status Verified Date:
2016-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
This is an exploratory study in patients with locally advanced or metastatic Non-small cell lung cancer Patients who are eligible to apply for Extended Access Program of crizotinib must have ALK translocation detected by RT-PCR IHC or FISH analyses methods
Detailed Description:
This is an exploratory non-randomized study in patients with locally advanced or metastatic NSCLC Patients who are eligible to apply for Extended Access Program of crizotinib must have ALK translocation detected by RT-PCR IHC or FISH analyses methods Patients who failed and progressed through at least one line of platinum containing chemotherapy and who are older than 70 years old with failure of chemotherapy will be eligible for this study We will screen EML4-ALK fusion gene by RT-PCR HotSart Taq Master Mix Kits Qiaqen from patients malignant pleural effusions and the detail was described in previous study1 We will also use IHC analyses 5A4 monoclonal antibody Novocastra to screen ALK protein expression in patients FFPE tumor sections We will further do FISH analysis by using commercial Vysis LSI ALK Dual Color Break Apart Rearrangement Probe 2p23 Abott Molecular Inc Des Plaines IL to detect ALK rearrangement in positive screening tumors Samples are deemed to be FISH-positive if more than 15 of 50 scored tumor cells had split ALK 5 and 3 probe signals or had isolated 3 signals5 Patients who have ALK rearrangement determined in any of 3 molecular analyses methods and apply for crizotinib will receive 250mg of crizotinib twice daily until disease progression unacceptable toxicities or the withdrawal of consent is noted
Patients will be monitored carefully for the development of adverse experiences Adverse experiences will be evaluated according to criteria outlined in the National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE version 40 Patients will also be monitored for clinical andor radiographic evidence of disease progression according to RECIST 11
The primary endpoint of the study is overall response rate in patients with positive ALK determined from different molecular analysis methods The secondary endpoint included overall response in specific subsets of patients progression-free survival PFS and overall survival OS at 1 year PFS is defined as the time from day 1 of crizotinib to disease progression or patients death OS was defined as the time from day 1 of crizotinib treatment to patients death
During the treatment patients will have safety measurements performed at specified time points Disease response will be assessed during the study by radiographic eg CT or MRI and clinical eg physical examination evaluations if applicable Overall tumor response will be assessed at the designated time points every 12 weeks using Response Evaluation Criteria in Solid Tumors RECIST Version 11 The crizotinib treatment could be continued after RECIST-defined disease progression if clinical benefit is still noted by primary physician
Patients will be monitored carefully for the development of adverse experiences Adverse experiences will be evaluated according to criteria outlined in the National Cancer Institute NCI Common Terminology Criteria for Adverse Events CTCAE version 40 Patients will also be monitored for clinical andor radiographic evidence of disease progression according to RECIST 11
The primary endpoint of the study is overall response rate in patients with positive ALK determined from different molecular analysis methods The secondary endpoint included overall response in specific subsets of patients progression-free survival PFS and overall survival OS at 1 year PFS is defined as the time from day 1 of crizotinib to disease progression or patients death OS was defined as the time from day 1 of crizotinib treatment to patients death
During the treatment patients will have safety measurements performed at specified time points Disease response will be assessed during the study by radiographic eg CT or MRI and clinical eg physical examination evaluations if applicable Overall tumor response will be assessed at the designated time points every 12 weeks using Response Evaluation Criteria in Solid Tumors RECIST Version 11 The crizotinib treatment could be continued after RECIST-defined disease progression if clinical benefit is still noted by primary physician
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