UVEA-Brig
Research type
Research Study
Full title
Use Via Expanded Access to Brigatinib
IRAS ID
239774
Contact name
Sanjay Popat
Contact email
Sponsor organisation
Takeda Pharmaceuticals International AG
Duration of Study in the UK
1 years, 9 months, 2 days
Research summary
Brigatinib is a new medicine that is currently undergoing marketing approval for treatment of a type of lung cancer. Whilst it has been in the process of being marketed the drug has been prescribed to some patients on a named patient basis by their oncologist, via an expanded access programme.
Up to this point, the capture of data on the use and effectiveness of brigatinib has not been optimal so this study has been designed to supplement these data. It is designed to provide a more comprehensive assessment of the treatments used prior to brigatinib, the use and effectiveness of brigatinib, and the treatments potentially used after brigatinib, all within the context of the expanded access programme.
This study is a retrospective chart review, patients will not be asked to come for any study visits. The hospital staff will collect existing data relating to the patients' lung cancer type and stage, the treatment they received (brigatinib and other treatments) and the outcome of the treatment, from their medical record and enter it into study specific forms.
The study will last 18 months, for each patient there will be an ‘Initial’ retrospective data collection, and for some patients there will be a ‘Refresh’ retrospective data collection after the initial collection, to ensure 12-18 months of follow-up data is collected.REC name
London - Riverside Research Ethics Committee
REC reference
18/LO/0215
Date of REC Opinion
1 Feb 2018
REC opinion
Favourable Opinion