Darolutamide roll-over study
Research type
Research Study
Full title
An open-label, single arm, roll-over study to provide continued treatment with darolutamide in participants who were enrolled in previous Bayer-sponsored studies.
IRAS ID
280190
Contact name
Alison Birtle
Contact email
Sponsor organisation
Bayer AG
Eudract number
2019-003618-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor’s visits as often as they did in the previous study.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
20/LO/0790
Date of REC Opinion
24 Jun 2020
REC opinion
Further Information Favourable Opinion