dc.contributor
Institut Català de la Salut
dc.contributor
[Bono P, Peltola KJ] Comprehensive Cancer Centre, Helsinki University Central Hospital, Helsinki, Finland. Faculty of Medicine, University of Helsinki, Helsinki, Finland. [Massard C] Cancer Centre, Drug Development Department, DITEP, Gustave Roussy, Villejuif, France. [Azaro A, Rodon JA] Servei d’Oncologia Mèdica, Vall d'Hebron Hospital Universitari, Barcelona, Spain. [Italiano A] Early Phase Trials Unit, Institut Bergonié, Bordeaux, France. Faculty of Medicine, University of Bordeaux, Talence, France. [Kristeleit RS] Research Department of Oncology, University College London Cancer Institute, London, UK
dc.contributor
Vall d'Hebron Barcelona Hospital Campus
dc.contributor.author
Bono, Petri
dc.contributor.author
Massard, Christophe
dc.contributor.author
Peltola, Katriina J
dc.contributor.author
Azaro Pedrazzoli, Analía Beatriz
dc.contributor.author
Kristeleit, Rebecca S
dc.contributor.author
Rodon Ahnert, Jordi
dc.contributor.author
Italiano, Antoine
dc.date.accessioned
2025-10-24T10:33:37Z
dc.date.available
2025-10-24T10:33:37Z
dc.date.issued
2021-10-20T08:11:25Z
dc.date.issued
2021-10-20T08:11:25Z
dc.identifier
Bono P, Massard C, Peltola KJ, Azaro A, Italiano A, Kristeleit RS, et al. 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. ESMO Open. 2020 Dec;5(6):e001081.
dc.identifier
https://hdl.handle.net/11351/6423
dc.identifier
10.1136/esmoopen-2020-001081
dc.identifier
000597167800002
dc.identifier.uri
https://hdl.handle.net/11351/6423
dc.description.abstract
Estudi d'escalada de dosis; Fase I; Tumors sòlids
dc.description.abstract
Estudio de escalada de dosis; Fase I; Tumores sólidos
dc.description.abstract
Dose escalation study; Phase I; Solid tumours
dc.description.abstract
Background
Genetic 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.
Methods
Open-label, non-randomised, multicentre, phase I/IIa dose escalation and expansion study in patients with advanced or metastatic solid tumours.
Results
Overall, 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.
Conclusion
This 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.
dc.description.abstract
The study was sponsored by Orion Corporation, Orion Pharma, Espoo, Finland.
dc.format
application/pdf
dc.format
application/pdf
dc.relation
ESMO Open;5(6)
dc.relation
https://doi.org/10.1136/esmoopen-2020-001081
dc.rights
Attribution-NonCommercial 4.0 International
dc.rights
http://creativecommons.org/licenses/by-nc/4.0/
dc.rights
info:eu-repo/semantics/openAccess
dc.subject
Càncer - Tractament
dc.subject
DISEASES::Neoplasms::Neoplastic Processes::Neoplasm Metastasis
dc.subject
DISEASES::Neoplasms
dc.subject
Other subheadings::Other subheadings::Other subheadings::/drug therapy
dc.subject
ENFERMEDADES::neoplasias::procesos neoplásicos::metástasis neoplásica
dc.subject
ENFERMEDADES::neoplasias
dc.subject
Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia
dc.title
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
dc.type
info:eu-repo/semantics/article
dc.type
info:eu-repo/semantics/publishedVersion
