Study to Evaluate Real-world Pharmacoeconomics of Crizotinib in NSCLC Patients
NCT ID: NCT02228421
Last Updated: 2020-03-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
29 participants
OBSERVATIONAL
2015-02-28
2020-03-31
Brief Summary
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NSCLC represent 80% of all new cases of lung cancer. One molecular subtype of NSCLC is the ALK-positive subtype. The anaplastic lymphoma kinase (ALK) is a transmembrane receptor tyrosine kinase. Activation of ALK occurs through the formation of gene fusions and in NSCLC, the gene fusion partner for ALK is primarily EML4. The resulting fusion protein is capable of activating the ALK kinase domain, leading to cell growth. The estimated prevalence for ALK rearrangements in NSCLC is 3-5%, and is more commonly found amongst patients with adenocarcinoma histology, in never smokers and in those who are known to be wild type for EGFR and KRAS.
Crizotinib is a potent inhibitor of ALK and is approved for the treatment of advanced ALK+ NSCLC patients. This is an example of personalized medicine, where patients are selected for treatment based upon a molecular assay, and are provided a specific therapy (crizotinib) for their disease. The pharmacoeconomic impact of using genetic information in early treatment decisions in NSCLC has not been determined.
The study will enable real-life Heath Economics and Outcome Research (HEOR).
Approximately 90 patients will be recruited. Patients will be asked to complete quality-of-life questionnaires at regular intervals in a real-life setting of treatment with crizotinib.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Presence of the ALK-fusion oncogene (ALK+) as determined using a validated testing platform
* Planned first or second-line treatment with crizotinib
* Signed and dated IRB-approved informed consent document
* Ability to read and understand English or French
* 18 years of age or older
18 Years
ALL
No
Sponsors
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Personalized Medicine Partnership for Cancer
OTHER
Jewish General Hospital
OTHER
PeriPharm
OTHER
Responsible Party
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Principal Investigators
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Jason Agulnik, MD
Role: PRINCIPAL_INVESTIGATOR
Jewish General Hospital
Victor Cohen, MD
Role: PRINCIPAL_INVESTIGATOR
Jewish General Hospital
Locations
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The Ottawa Hospital
Ottawa, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
CSSS de Rimouski-Neigette
Rimouski, Quebec, Canada
Countries
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Other Identifiers
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PMPC-03
Identifier Type: -
Identifier Source: org_study_id
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