Status: Finalised First registered on: 02/12/2014
Last updated on: 18/07/2018
1. Study identification
EU PAS Register NumberEUPAS8097
Official titleA multinational active safety surveillance study of crizotinib in Europe
Study title acronym
Study typeActive surveillance
Brief description of the studyCrizotinib (XALKORI®), an orally administered selective ATP competitive small molecule inhibitor of the anaplastic lymphoma kinase (ALK), has been approved multinational, including in Europe, for the treatment of patients with previously treated locally advanced ALK-positive non small cell lung cancer (NSCLC). This non interventional Post-Authorization Safety Study (PASS) examines the safety and effectiveness of crizotinib among ALK-positive NSCLC patients using existing healthcare databases in Denmark, Sweden, Finland, the Netherlands and the United States. The primary objective of this study is to estimate the incidence of adverse events that were observed in crizotinib clinical trials including 1) hepatotoxicity, 2) pneumonitis/ interstitial lung disease, 3) QT interval prolongation, 4) bradycardia, and 5) vision disorder. Less frequently observed adverse events, i.e. renal cysts, edema, leukopenia, neuropathy, and photosensitivity as well as patient survival will also be examined. To contextualize the incidence of the adverse event in crizotinib treated patients, the incidence of these adverse events in patients prescribed three other orally administered tyrosine kinase inhibitors, ceritinib, erlotinib and gefitinib, will be estimated. The international classification of diseases (ICD) diagnostic codes and procedural codes will be used to capture the safety endpoints in the healthcare databases. Additionally, a validation sub study among all crizotinib patients and the same number of ceritinib, erlotinib or gefitinib patients will evaluate the accuracy of the ICD-based endpoint classifications. The validation study will compare ICD-based classification of primary endpoints to endpoints adjudicated by a panel of experts using data abstracted from patient medical records.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsAarhus University Dept. of Clinical Epidemiology
Department/Research groupDepartment of Clinical Epidemiology
Organisation/affiliationAarhus University / Aarhus University Hospital
Website/Homepagewww.kea.au.dk
Details of (Primary) lead investigator
Title Professor
Last name Sørensen
First name Henrik Toft
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?5

Centre for Pharmacoepidemiology (CPE)
IQVIA
PHARMO Institute
Aarhus University Dept. of Clinical Epidemiology
Countries in which this study is being conducted
International study

Denmark
Finland
Netherlands
Sweden
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed19/03/201409/07/2014
Start date of data collection30/12/201430/12/2014
Start date of data analysis
Date of interim report, if expected30/06/201630/06/2016
Date of final study report30/06/201812/06/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesPfizer Inc100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Huang
First name Kui
Address line 1235 East 42nd St
Address line 2 
Address line 3 
CityNew York 
Postcode10017 
CountryUnited States
Phone number (incl. country code)01212-7331309 
Alternative phone number 
Fax number (incl. country code) 
Email address kui.a.huang@pfizer.com
Public Enquiries
Title Dr 
Last name Huang 
First name Kui 
Address line 161-21 Saunders St 
Address line 2 
Address line 3 
CityRego Park 
Postcode11374 
CountryUnited States 
Phone number (incl. country code)01-212-7331309 
Alternative phone number 
Fax number (incl. country code) 
Email address kui.a.huang@pfizer.com 
Top