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

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

Study timelines

Date when funding contract was signed

Actual: 15/09/2011

Study start date

Actual: 19/09/2012

Data analysis start date

Actual: 12/09/2013

Date of interim report, if expected

Planned: 05/05/2014

Actual: 30/06/2014

Date of final study report

Planned: 26/11/2015

Actual: 23/11/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Vectibix_20101120_Protocol_11Feb14

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)