Study identification

PURI

https://redirect.ema.europa.eu/resource/20214

EU PAS number

EUPAS5681

Study ID

20214

Official title and acronym

Medical Records Review to Describe the Patterns of KRAS Testing and Vectibix Use in Europe (20101120)

DARWIN EU® study

No

Study countries

Belgium
Czechia
Denmark
France
Germany
Italy
Netherlands
Spain
Sweden

Study description

This non-interventional cross-sectional medical record review study will assess the prevalence of KRAS testing and the impact of the KRAS test result on patterns of Vectibix use in patients with metastatic colorectal cancer (mCRC) treated with Vectibix in selected European countries over 3 rounds. As the optimal use of Vectibix also requires accurate KRAS mutation testing, this study will also assess data from the laboratory that performed the KRAS test. The study will also monitor changes in the pattern of Vectibix treatment between the different rounds of the study.

Study status

Finalised
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution

Contact details

Global Development Leader Amgen, Inc

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

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

More details on funding

Amgen
Study protocol
Initial protocol
English (312.98 KB - 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 1 (imposed as condition of marketing authorisation)