Crizotinib Efficacy In Non-Small Cell Lung Cancer Patients With Anaplastic Lymphoma Kinase Translocation
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First Received Date ICMJE | June 28, 2012 | ||||||||
Last Updated Date | July 10, 2012 | ||||||||
Start Date ICMJE | June 2012 | ||||||||
Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Overall response rate in patients with positive ALK determined from different molecular analysis methods. [ Time Frame: It is defined as the time from day 1 of crizotinib to disease progression or patient's death. ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT01637597 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Outcome Measures ICMJE | |||||||||
Original Other Outcome Measures ICMJE | |||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Crizotinib Efficacy In Non-Small Cell Lung Cancer Patients With Anaplastic Lymphoma Kinase Translocation | ||||||||
Official Title ICMJE | An Exploratory Study Of Crizotinib Efficacy In Non-Small Cell Lung Cancer Patients With Anaplastic Lymphoma Kinase Translocation Determined By Different Molecular Diagnostic Methods | ||||||||
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. |
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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 study[1]. 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' signals[5]. 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 4.0. Patients will also be monitored for clinical and/or radiographic evidence of disease progression according to RECIST 1.1. 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 patient's death. OS was defined as the time from day 1 of crizotinib treatment to patient's death. During the treatment, patients will have safety measurements performed at specified time points. Disease response will be assessed during the study by radiographic (e.g., CT or MRI), and clinical (e.g., 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 1.1). The crizotinib treatment could be continued after RECIST-defined disease progression if clinical benefit is still noted by primary physician. |
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Study Type ICMJE | Observational | ||||||||
Study Design ICMJE | Time Perspective: Prospective | ||||||||
Biospecimen | Retention: Samples With DNA Description: Blood and tumor tissue are being collected during the course of this study, to assess the safety and tolerability and spectrum of side effects of the study drug. However, it is possible that after completion of all study-related analyses, some volume of samples may remain. These left-over samples could be a valuable resource for future research. Before any left-over samples can be used for any research other than that specified in the protocol, patient must sign an additional future use consent from indicating they give their permission for these samples to be used in future research. By signing the main consent form, patients are only giving their permission to use their samples for the study related procedures. |
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Sampling Method | Non-Probability Sample | ||||||||
Study Population | Patients with locally advanced or metastatic NSCLC who are eligible to apply for Extended Access Program of crizotinib must have ALK translocation detected by RT-PCR, IHC or FISH analyses methods. |
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Condition ICMJE | Non-small Cell Lung Cancer(NSCLC) | ||||||||
Intervention ICMJE | |||||||||
Study Group/Cohort (s) | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE | 42 | ||||||||
Estimated Completion Date | April 2014 | ||||||||
Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 20 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | Taiwan | ||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT01637597 | ||||||||
Other Study ID Numbers ICMJE | 201204080RIC | ||||||||
Has Data Monitoring Committee | No | ||||||||
Responsible Party | National Taiwan University Hospital | ||||||||
Study Sponsor ICMJE | National Taiwan University Hospital | ||||||||
Collaborators ICMJE | |||||||||
Investigators ICMJE |
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Information Provided By | National Taiwan University Hospital | ||||||||
Verification Date | June 2012 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |