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Study to Evaluate Resistance Mechanisms and Real-world Pharmacoeconomics of Crizotinib in NSCLC Patients

NCT02041468 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 29

Last updated 2017-08-30

No results posted yet for this study

Summary

This is a phase IV multicenter trial to evaluate the mechanisms of resistance and pharmacoeconomic (PE) impact of crizotinib and its companion diagnostic test used in a real-life setting in advanced ALK-positive non-small cell lung cancer (NSCLC) patients.

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

  • Non-small Cell Lung Cancer Metastatic

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Quebec Clinical Research Organization in Cancer

    collaborator OTHER

  • PeriPharm

    collaborator OTHER

  • Personalized Medicine Partnership for Cancer

    collaborator OTHER

  • Jewish General Hospital

    lead OTHER

Principal Investigators

  • Jason Agulnik, MD · Jewish General Hospital

  • Victor Cohen, MD · Jewish General Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2018-03-31
Completion
2018-06-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02041468 on ClinicalTrials.gov