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
First published:
21/02/2024
Institution
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

Contact details

Glodal Development Leader Amgen, Inc

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Data analysis start date

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 (569.55 KB - PDF)View document
Updated protocol
English (754.68 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable