Study identification

PURI

https://redirect.ema.europa.eu/resource/44928

EU PAS number

EUPAS12963

Study ID

44928

Official title and acronym

A descriptive study of potential sight threatening event and severe visual loss following exposure to XALKORI (crizotinib)

DARWIN EU® study

No

Study countries

Albania
Argentina
Armenia
Aruba
Australia
Austria
Bahrain
Belarus
Belgium
Belize
Bosnia and Herzegovina
Bulgaria
Canada
Cayman Islands
Chile
China
Colombia
Costa Rica
Croatia
Cyprus
Denmark
Dominican Republic
Ecuador
Egypt
El Salvador
Estonia
Finland
France
Germany
Greece
Guatemala
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Ireland
Israel
Italy
Jamaica
Japan
Jordan
Kazakhstan
Korea, Republic of
Kuwait
Latvia
Lebanon
Liechtenstein
Lithuania
Luxembourg
Macau
Madagascar
Malaysia
Mexico
Montenegro
Morocco
Netherlands
New Zealand
Norway
Oman
Panama
Peru
Philippines
Poland
Portugal
Qatar
Romania
Russian Federation
Saudi Arabia
Singapore
Slovakia
Slovenia
Spain
Sweden
Switzerland
Taiwan
Thailand
Trinidad and Tobago
Tunisia
Türkiye
Ukraine
United Arab Emirates
United Kingdom
United States
United States Minor Outlying Islands
Uruguay
Uzbekistan
Venezuela, Bolivarian Republic of
Western Sahara
Yemen
Zambia
Zimbabwe
Åland Islands

Study description

Crizotinib is a selective small‑molecule inhibitor of the anaplastic lymphoma kinase (ALK) receptor tyrosine kinase (RTK) and its oncogenic variants (ie, ALK fusion events and selected ALK mutations). Crizotinib is also an inhibitor of the hepatocyte growth factor receptor (HGFR, c‑Met), ROS1, and Recepteur d’Origine Nantais (RON) RTKs. Crizotinib has received full or conditional approvals for the treatment of patients with ALK‑positive advanced non‑small cell lung cancer (NSCLC) in over 85 countries including the United States, the European Union, and Japan. This post‑marketing requirement by the US FDA is a post‑authorization safety study (PASS) designed to collect data on potential sight threatening event (PSTE) and severe visual loss (SVL) in patients being treated with crizotinib.

Study status

Finalised
Research institutions and networks

Institutions

Contact details

De Luise Cynthia

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Pfizer Inc
Study protocol
Initial protocol

A8081062_FINAL_PROTOCOL_CLEAN_16MAR 2016_register

English (1.98 MB - PDF)View document
Updated protocol

A8081062_Protocol_Amendment_1 28 April 2017_EU PAS

English (4.04 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)