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Trial record 1 of 1 for:    NCT02041468
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Study to Evaluate Resistance Mechanisms and Real-world Pharmacoeconomics of Crizotinib in NSCLC Patients

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ClinicalTrials.gov Identifier: NCT02041468
Recruitment Status : Unknown
Verified August 2017 by Dr. Jason Agulnik, Jewish General Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 22, 2014
Last Update Posted : August 30, 2017
Sponsor:
Collaborators:
Pfizer
Quebec Clinical Research Organization in Cancer
PeriPharm
Personalized Medicine Partnership for Cancer
Information provided by (Responsible Party):
Dr. Jason Agulnik, Jewish General Hospital

Tracking Information
First Submitted Date December 20, 2013
First Posted Date January 22, 2014
Last Update Posted Date August 30, 2017
Study Start Date January 2014
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 17, 2014)
The pharmacoeconomic impact of using personalized medicine for the treatment of ALK+ lung cancer. [ Time Frame: From the date of registration until date of death from any cause, assessed up to 60 months. ]
Pharmacoeconomic impact (cost-effectiveness and cost utility) will be evaluated by questionnaires completed by the patient and caregiver. These include quality of life, health resource utilization, work productivity and activity impairment, and health questionnaires
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 17, 2014)
  • Type of resistance mechanisms identified in crizotinib-resistant tumors [ Time Frame: At progression of disease, an expected average of 24 months. ]
    A biopsy will be taken from a metastatic lesion that has progressed despite treatment with crizotinib. Genomic material will be isolated and sequenced to identify causes of acquired resistance to crizotinib.
  • Change in blood-based biomarkers of response to crizotinib. [ Time Frame: From the date of registration until the date of treatment discontinuation, an expected average of 24 months. ]
    Plasma will be isolated from patients pre-treatment, at every disease assessment, at progression of disease, and at treatment discontinuation. This will be used to identify changes in blood-based biomarkers using proteomics analysis by mass spectrometry.
  • Number of participants with adverse events related to the biopsy procedure. [ Time Frame: Up to 4 years. ]
    Adverse events possibly, probably or definitely related to the biopsy procedure will be reported according to the The NCI's Common Toxicity Criteria version 4.0
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Study to Evaluate Resistance Mechanisms and Real-world Pharmacoeconomics of Crizotinib in NSCLC Patients
Official Title A Phase IV Multicenter Trial to Evaluate the Resistance Mechanisms and Real-world Pharmacoeconomics of Crizotinib and Its Companion Diagnostic Test in Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC) Patients
Brief 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.

Detailed Description

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.

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
The study will collect plasma, platelet-depleted plasma, tumor tissue (biopsy of a metastatic site that has acquired resistant to treatment) and primary archived tissue.
Sampling Method Non-Probability Sample
Study Population Patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) found positive for ALK mutation from participating hospitals in Quebec.
Condition Non-small Cell Lung Cancer Metastatic
Intervention Not Provided
Study Groups/Cohorts
  • Pharmacoeconomic main study
    Patients from Quebec and Ontario (first or second line treatment)
  • Biomarker sub-study
    Patients from Quebec only (first or second line treatment)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Actual Enrollment
 (submitted: April 1, 2016)
29
Original Estimated Enrollment
 (submitted: January 17, 2014)
90
Estimated Study Completion Date June 2018
Estimated Primary Completion Date March 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with histologically confirmed locally advanced or metastatic NSCLC
  • 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:

  • Acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease.
  • Unwilling to provide consent for genetic studies of the tumor, whole blood, or plasma specimens.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02041468
Other Study ID Numbers Q-CROC-05
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Dr. Jason Agulnik, Jewish General Hospital
Study Sponsor Jewish General Hospital
Collaborators
  • Pfizer
  • Quebec Clinical Research Organization in Cancer
  • PeriPharm
  • Personalized Medicine Partnership for Cancer
Investigators
Principal Investigator: Jason Agulnik, MD Jewish General Hospital
Principal Investigator: Victor Cohen, MD Jewish General Hospital
PRS Account Jewish General Hospital
Verification Date August 2017