Study to Evaluate Resistance Mechanisms and Real-world Pharmacoeconomics of Crizotinib in NSCLC Patients
NCT ID: NCT02041468
Last Updated: 2017-08-30
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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UNKNOWN
29 participants
OBSERVATIONAL
2014-01-31
2018-06-30
Brief Summary
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The study will address two anticipated issues surrounding personalized medicine and treatment with crizotinib:
* it will enable real-life Heath Economics and Outcome Research (HEOR)
* it will validate and/or identify new blood-based or tissue-based biomarkers of resistance to crizotinib.
At least 30 patients will be recruited in Quebec and Ontario for the PE study. Patients will be asked to complete quality-of-life questionnaires at regular intervals in a real-life setting of treatment with crizotinib.
Approximately 25 patients will be recruited to the biomarker sub-study in Quebec to understand resistance mechanisms of crizotinib. In these patients, a biopsy from any accessible metastatic lesion will be obtained when the patient is no longer responding to treatment, as well as blood sampling during regular treatment visits.
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Detailed Description
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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. Despite the benefits of crizotinib, some patients do not respond to treatment and most patients will eventually develop resistance. To date, it is unclear why some rare patients do not respond to treatment and the resistance mechanisms of crizotinib have not been fully elucidated.
The study will address two anticipated issues surrounding personalized medicine and treatment with crizotinib:
* it will enable real-life Heath Economics and Outcome Research (HEOR)
* it will validate and/or identify new blood-based or tissue-based biomarkers of resistance to crizotinib.
At least 30 patients will be recruited in Quebec and Ontario for the PE study. Patients will be asked to complete quality-of-life questionnaires at regular intervals in a real-life setting of treatment with crizotinib.
Approximately 25 patients will be recruited to the biomarker sub-study in Quebec to understand resistance mechanisms of crizotinib. In these patients, a biopsy from any accessible metastatic lesion will be obtained when the patient is no longer responding to treatment, as well as blood sampling during regular treatment visits.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pharmacoeconomic main study
Patients from Quebec and Ontario (first or second line treatment)
No interventions assigned to this group
Biomarker sub-study
Patients from Quebec only (first or second line treatment)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Presence of the ALK-fusion oncogene (ALK+) as determined using a validated testing platform
* Measurable disease according to RECIST v. 1.1
* Planned or ongoing 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
Exclusion Criteria
* Unwilling to provide consent for genetic studies of the tumor, whole blood, or plasma specimens.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Quebec Clinical Research Organization in Cancer
OTHER
PeriPharm
OTHER
Personalized Medicine Partnership for Cancer
OTHER
Jewish General Hospital
OTHER
Responsible Party
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Dr. Jason Agulnik
Principal Investigator
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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Ottawa Hospital
Ottawa, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
McGill University Health Center (JGH, St-Mary's, MGH, RVH)
Montreal, Quebec, Canada
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, Canada
Centre hospitalier de l'Université de Montréal
Montreal, Quebec, Canada
CSSS Rimouski
Rimouski, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec, Canada
Institut Universitaire de cardiologie et de pneumonologie
Québec, , Canada
Countries
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References
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Katayama R, Shaw AT, Khan TM, Mino-Kenudson M, Solomon BJ, Halmos B, Jessop NA, Wain JC, Yeo AT, Benes C, Drew L, Saeh JC, Crosby K, Sequist LV, Iafrate AJ, Engelman JA. Mechanisms of acquired crizotinib resistance in ALK-rearranged lung Cancers. Sci Transl Med. 2012 Feb 8;4(120):120ra17. doi: 10.1126/scitranslmed.3003316. Epub 2012 Jan 25.
Camidge DR, Doebele RC. Treating ALK-positive lung cancer--early successes and future challenges. Nat Rev Clin Oncol. 2012 Apr 3;9(5):268-77. doi: 10.1038/nrclinonc.2012.43.
Kwak EL, Bang YJ, Camidge DR, Shaw AT, Solomon B, Maki RG, Ou SH, Dezube BJ, Janne PA, Costa DB, Varella-Garcia M, Kim WH, Lynch TJ, Fidias P, Stubbs H, Engelman JA, Sequist LV, Tan W, Gandhi L, Mino-Kenudson M, Wei GC, Shreeve SM, Ratain MJ, Settleman J, Christensen JG, Haber DA, Wilner K, Salgia R, Shapiro GI, Clark JW, Iafrate AJ. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med. 2010 Oct 28;363(18):1693-703. doi: 10.1056/NEJMoa1006448.
Doebele RC, Pilling AB, Aisner DL, Kutateladze TG, Le AT, Weickhardt AJ, Kondo KL, Linderman DJ, Heasley LE, Franklin WA, Varella-Garcia M, Camidge DR. Mechanisms of resistance to crizotinib in patients with ALK gene rearranged non-small cell lung cancer. Clin Cancer Res. 2012 Mar 1;18(5):1472-82. doi: 10.1158/1078-0432.CCR-11-2906. Epub 2012 Jan 10.
Couetoux du Tertre M, Marques M, McNamara S, Gambaro K, Hoffert C, Tremblay L, Bouchard N, Diaconescu R, Blais N, Couture C, Pelsser V, Wang H, McIntosh L, Hindie V, Parent S, Cortes L, Breton YA, Pottiez G, Croteau P, Higenell V, Izzi L, Spatz A, Cohen V, Batist G, Agulnik J. Discovery of a putative blood-based protein signature associated with response to ALK tyrosine kinase inhibition. Clin Proteomics. 2020 Feb 7;17:5. doi: 10.1186/s12014-020-9269-6. eCollection 2020.
Other Identifiers
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Q-CROC-05
Identifier Type: -
Identifier Source: org_study_id
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