RECORA- Regorafenib in patients with metastatic colorectal cancer (mCRC) after failure of standard therapy

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/23329
• EU PAS number:
  EUPAS4934
• Study ID:
  23329
• Official title and acronym:
  RECORA- Regorafenib in patients with metastatic colorectal cancer (mCRC) after failure of standard therapy
• DARWIN EU® study:
  No
• Study countries:
  Germany
• Study description:
  The purpose of the study is to investigate the safety and effectiveness of Stivarga in patients with metastatic colorectal carcinoma in routine use in Germany. The study is purely observational, only data from routine treatment are to be collected. The treatment and treatment conditions are solely at discretion of the treating physician.
• Study status:
  Finalised

Research institution and networks

Institutions

Bayer AG

Multiple centres: 100 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 22/07/2013

Study start date

Planned: 15/10/2013

Actual: 31/10/2013

Date of final study report

Planned: 31/03/2018

Actual: 09/03/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bayer AG

Study protocol

Initial protocol

SV1313_CSP_2013-07-22_signed

Updated protocol

16665_SV1313_CSP_3.0_2016-04-06_signed

Regulatory

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