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

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ClinicalTrials.gov Identifier: NCT02228421
Recruitment Status : Active, not recruiting
First Posted : August 29, 2014
Last Update Posted : October 6, 2016
Sponsor:
Collaborators:
Personalized Medicine Partnership for Cancer
Jewish General Hospital
Information provided by (Responsible Party):
PeriPharm

Brief Summary:

This is a phase IV multicenter trial to evaluate the 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.

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.


Condition or disease
Non-small Cell Lung Cancer Metastatic

Study Type : Observational
Actual Enrollment : 29 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Phase IV Multicenter Trial to Evaluate Real-world Pharmacoeconomics of Crizotinib and Its Companion Diagnostic Test in Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC) Patients
Study Start Date : February 2015
Estimated Primary Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Crizotinib




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) found positive for ALK mutation.
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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228421


Locations
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
CSSS de Rimouski-Neigette
Rimouski, Quebec, Canada, J5L 5T1
Sponsors and Collaborators
PeriPharm
Personalized Medicine Partnership for Cancer
Jewish General Hospital
Investigators
Principal Investigator: Jason Agulnik, MD Jewish General Hospital
Principal Investigator: Victor Cohen, MD Jewish General Hospital

Responsible Party: PeriPharm
ClinicalTrials.gov Identifier: NCT02228421     History of Changes
Other Study ID Numbers: PMPC-03
First Posted: August 29, 2014    Key Record Dates
Last Update Posted: October 6, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Crizotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action