KIDES: safety and tolerability of ODM-203 in advanced solid tumours
Research type
Research Study
Full title
Safety and tolerability of single and repeated doses of ODM-203: an open-label, non-randomised, uncontrolled, dose escalation, multicentre, first-in-human study in subjects with advanced solid tumours.
IRAS ID
211158
Contact name
Rebecca Kristeleit
Contact email
Sponsor organisation
Orion Corporation Orion Pharma
Eudract number
2013-000658-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
The study drug to be investigated is ODM-203, which is being developed for solid tumours.
The study will be conducted in two parts: Part 1 (increasing dose-completed) and Part 2 (expansion- planned).
The main purpose of Part 1 of this study was to find a dose of ODM-203 that was well tolerated in the treatment of cancer. Part 2 of the study will investigate further the dose and different dosing schedules to look for the best option for the treatment of cancer and in which cancer types ODM-203 is an effective treatment.
Up to a maximum of 117 participants (male or female) diagnosed with different types of cancer will participate in this study. The study is planned to be run in several hospitals in Europe.
Participation in this study will last from 28 days to more than 6 months in the absence of any safety concerns and provided the disease does not progress further. During this time participants will be asked to come to the hospital for a minimum of 12 visits. There will be three periods in this study: screening, treatment and post treatment.
The study is being funded by Orion Corporation Orion Pharma.REC name
London - City & East Research Ethics Committee
REC reference
16/LO/1744
Date of REC Opinion
23 Nov 2016
REC opinion
Further Information Favourable Opinion