F-I-H study of ODM-207 in patients with advanced solid tumours
Research type
Research Study
Full title
Safety and pharmacokinetics of ODM-207 in patients with selected advanced solid tumours: an open-label, non-randomised, uncontrolled, multi-centre, first-in-human study with cohort expansion
IRAS ID
211863
Contact name
Johann de Bono
Contact email
Sponsor organisation
Orion Corporation Orion Pharma
Eudract number
2015-004826-32
Duration of Study in the UK
3 years, 5 months, 1 days
Research summary
This study is looking at patients with solid advanced tumours. Patients with a number of different cancer diagnoses will be enrolled (For example, ovarian carcinoma or melanoma). Furthermore, the patient’s cancer will be histologically or cytologically confirmed as advanced or metastatic (Cancers which have spread from its origin to somewhere else in the body).
Patients enrolled on the study will either be resistant to currently available treatment or will have no treatment available. The primary objectives for part 1 are to evaluate the safety and tolerability, define the maximum tolerated dose (MTD) and dose limiting toxicities (DLTs) if possible, and define the recommended doses and dosing schedules of ODM-207 for Part 2 of the study.
It is expected that 144 patients will participate in this study, which will be taking place in up to 20 sites In Europe.
REC name
London - Central Research Ethics Committee
REC reference
16/LO/1653
Date of REC Opinion
24 Oct 2016
REC opinion
Further Information Favourable Opinion