Regorafenib rollover study

• Research type

  Research Study

• Full title

  A single arm, open-label, multicentre Phase 2 study of regorafenib in participants who have been treated in a previous Bayer-sponsored regorafenib study (monotherapy or combination treatment) that has reached the primary completion endpoint or the main data analysis, or has been stopped prematurely.

• IRAS ID

  258406

• Contact name

  Paul Nathan

• Contact email

  p.nathan@nhs.net

• Sponsor organisation

  Bayer AG

• Eudract number

  2018-003650-24

• Duration of Study in the UK

  4 years, 8 months, 9 days

• Research summary

  The primary purpose of the program is to enable participants, currently receiving regorafenib in a Bayer-sponsored clinical trial and assessed by the principal investigator (PI) to be benefiting, to continue regorafenib treatment after their respective study has reached the primary completion endpoint, or main data analysis, or has been stopped prematurely. It is also to allow the continued documentation of safety information.

  Lay summary of study results: Lay summary of results are available here:

  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3Du001.QwnS5iG-2B4nwcunWxC03fkNzUSRn0oHYd9v9Cv76xcZG1BP9YStADSFXMHjSLv9V6SD2snRjmOu4NTVC7ObdNWJneTbIK7I0LSuB-2FneBIXiXgv7II9JSYCMxv2qMzlFrsbHn5c410WX1hdRSTMrJ3v8yi4q0tEm1YAbuERWmFLWYNHh-2BJ1kCuSZwn1bSvjmsZokhJP25TnJ5QopGFpRuq4P6J-2FD11CPWNusRAKTF-2FBP4-3DN-Sk_a04dWCHmDh7gi4hRuvmsd-2FMEDkPNm6D0IRdq0o1v81dLIceOCONBjeFnFYzpCF2LLDq5VhfBkTkwqQ2ZBFF7c4VPBQW4p2t-2Fplv9y7ZM6bv-2Bps-2BzAdi12G3elDi-2FwkOTU99cLDazx-2FKO1b4TPQmRWp2FM9-2Bw81IxubvGaePsyzdFRUIQwQAabbZW2i48kAo37D8TesgggqDfMkEk0L9Jjw-3D-3D&data=05%7C02%7Cbrightonandsussex.rec%40hra.nhs.uk%7C1a1af88679e34d01ee1908dc3f866d0b%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638455093787358156%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=1CCRxfTGrcad1vK9mb0%2FmIF73riC5wBlRmSL8MstXSM%3D&reserved=0

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  19/LO/0123

• Date of REC Opinion

  20 Feb 2019

• REC opinion

  Favourable Opinion