Prospective Observational Cohort Study to Describe the Use of Vectibix® in Combination With Chemotherapy in Routine Clinical Practice for Patients With Wild-type KRAS Metastatic Colorectal Cancer (20120100)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20948
• EU PAS number:
  EUPAS3180
• Study ID:
  20948
• Official title and acronym:
  Prospective Observational Cohort Study to Describe the Use of Vectibix® in Combination With Chemotherapy in Routine Clinical Practice for Patients With Wild-type KRAS Metastatic Colorectal Cancer (20120100)
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany
• Study description:
  This is a multicenter, observational prospective cohort study in France and Germany. Treatment centres with a focus on treating subjects with mCRC will be prospectively defined for potential inclusion in the study. Eligible subjects will be enrolled and have retrospective data collected from Baseline up to the point of enrolment. All subsequent chemotherapy cycles and Vectibix® doses will be recorded prospectively. Each subject will have data collected until approximately 30 days after the end of Vectibix® treatment, death, withdrawal of consent, loss to follow-up or up to 12 months from the first dose of Vectibix®, whichever occurs first.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Vitanus GmbH Germany, Vinzenz von Paul Kliniken gGmbH Marienhospital Stuttgart Germany, Gemeinschaftspraxis Dr. Maintz, Groschek Hinske Germany, Onkologische Gemeinschaftspraxis Germany, Schwerpunktpraxis Hamatologie Onkologie Germany, Zentrum fur Onkologie und Urologie Rostock Germany, Onkologisches Zentrum Drs. Bauer and Kremers Germany, Dres. Kailhori/Langer/Nusch Germany, Schwerpunktpraxis Hamatologie und Onkologie German, Universitatsklinikum Magdeburg Germany

Study timelines

Date when funding contract was signed

Actual: 01/06/2012

Study start date

Planned: 10/12/2012

Actual: 10/12/2012

Data analysis start date

Planned: 21/04/2017

Actual: 12/04/2017

Date of final study report

Planned: 28/08/2017

Actual: 28/08/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Vectibix_20120100_Protocol_113012

Updated protocol

20120100 Protocol Amend 4 2015-04-09 English_2

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable