Canadian Retrospective Observational Study of MVASI in metastatic Colorectal Cancer (20180360)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/103370
• EU PAS number:
  EUPAS34590
• Study ID:
  103370
• Official title and acronym:
  Canadian Retrospective Observational Study of MVASI in metastatic Colorectal Cancer (20180360)
• DARWIN EU® study:
  No
• Study countries:
  Canada
• Study description:
  This retrospective observational chart review will describe the safety and effectiveness of treatment with MVASI in patients with metastatic Colorectal Cancer (mCRC) in Canada. The study will include adult patients, with confirmed histological or cytological adenocarcinoma of rectum or colon, stage 4, previously untreated, who receive MVASI as a part of their initial (first line) treatment for mCRC. The Data Collection will include data from the patient’s first dose of MVASI (the index date) until the date of the chart review. In addition, patients will have a look-back period including a 6-month look-back for patient demographics and baseline data, and a 5-year look back for prior adjuvant treatment and diagnosis of CRC
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 12 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 11/09/2018

Actual: 11/09/2018

Study start date

Planned: 20/03/2021

Actual: 16/03/2021

Data analysis start date

Planned: 10/11/2022

Actual: 10/11/2022

Date of interim report, if expected

Planned: 31/10/2021

Date of final study report

Planned: 14/04/2023

Actual: 06/04/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen Inc.

Study protocol

Initial protocol

EUPAS34590-35092

Regulatory

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