A Phase 1 Study of ONX 0801 in Advanced Solid Tumours - Version 1.0
Research type
Research Study
Full title
A Phase 1 Open-Label, Dose-Finding Study to Evaluate the Safety and Pharmacokinetics of ONX 0801, a Novel alpha-Folate Receptor-Mediated Thymidylate Synthase Inhibitor, in Patients with Advanced Solid Tumors
IRAS ID
25126
Contact name
Udai Banerji
Contact email
Sponsor organisation
Onyx Pharmaceuticals
Eudract number
2009-012933-31
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
This study is a first-in-man trial of ONX 0801 in patients with advanced solid tumours. The purposes of this study are to study different doses of the study drug to determine the maximum safe dose and to further understand the safety of the study drug; to understand what the body does to the study drug; to understand what the study drug does to the body and to measure any reduction in patients’ cancer tumor(s).
ONX 0801 is a novel alpha-folate receptor-mediated thymidylate synthase inhibitor. It acts by preventing a biochemical reaction within the cell stopping the cell growing. It combines a proven anti-cancer approach with specific targeting to receptors which are overexpressed on a number of tumours.
Up to 60 patients aged 18 and over with advanced solid tumours will be enrolled in the study in 2 hospitals within the UK (Royal Marsden, Sutton and Hammersmith, London). Additional sites may be added if necessary to meet enrolment targets. Patients will be given an infusion of ONX 0801 over 3 hours on Days 1, 8 and 15 of a three weekly (21 day) cycle and will undergo regular examinations, blood tests and scans to assess safety of the drug and the size of their tumour. Patient will be treated for up to a maximum of 12 months (as long as their cancer does not grow).REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
09/H0907/56
Date of REC Opinion
25 Aug 2009
REC opinion
Further Information Favourable Opinion