Details

Autor(en) / Beteiligte

• Bono, Petri
• Massard, Christophe
• Peltola, Katriina J
• Azaro, Analía
• Italiano, Antoine
• Kristeleit, Rebecca S
• Curigliano, Giuseppe
• Lassen, Ulrik
• Arkenau, Hendrik-Tobias
• Hakulinen, Pasi
• Garratt, Chris
• Ikonen, Tarja
• Mustonen, Mika V J
• Rodon, Jordi A

Titel

Phase I/IIa, open-label, multicentre study to evaluate the optimal dosing and safety of ODM-203 in patients with advanced or metastatic solid tumours

Ist Teil von

• ESMO open, 2020-12, Vol.5 (6), p.e001081, Article e001081

Ort / Verlag

England: Elsevier Ltd

Erscheinungsjahr

2020

Quelle

EZB Electronic Journals Library

Beschreibungen/Notizen

• BackgroundGenetic alterations in fibroblast growth factor receptor (FGFR) and vascular endothelial growth factor receptor (VEGFR) signalling are observed in various tumours. We report a first-in-human phase I/IIa trial evaluating tolerability, pharmacokinetics and preliminary antitumour activity of ODM-203, a novel FGFR and VEGFR inhibitor.MethodsOpen-label, non-randomised, multicentre, phase I/IIa dose escalation and expansion study in patients with advanced or metastatic solid tumours.ResultsOverall, 84 patients received treatment; optimal tablet dose was found to be 400 mg/day with food. All patients experienced at least one adverse event; the majority (89.2%) were grade 1 or 2% and 70.4% were considered treatment related. The most commonly reported events were bilirubin increase-related events (75%) and diarrhoea (50%).Overall response rate was 9.2% and median progression-free survival was 16.1 and 12.4 weeks for patients with aberrant or non-aberrant FGFR tumours. Median time on treatment was 10.1 weeks for all patients and 14.5 weeks for patients who received 400 mg tablets.ConclusionThis study suggests ODM-203 400 mg/day results in sufficient plasma concentrations and acceptable tolerability in most patients. Preliminary signs of therapeutic activity of ODM-203 in patients with solid tumours was observed.Trial registration numberNCT02264418.