An IQ consortium analysis of starting dose selection for oncology small molecule first-in-patient trials suggests an alternative NOAEL-based method can be safe while reducing time to the recommended phase 2 dose

The first-in-patient (FIP) starting dose for oncology agents should be reasonably safe and provide potential therapeutic benefit to the patient. For late-stage oncology patients, this dose is often based on the ICH S9 guidance, which was developed primarily based on experience with cytotoxic chemoth...

Descripción completa

Detalles Bibliográficos
Autores principales: Jessen, Bart A., Cornwell, Paul, Redmond, Sean, Visalli, Thomas, Lemper, Marie, Bunch, Todd, Hart, Timothy
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Berlin Heidelberg 2023
Materias:
Original Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10638197/
https://www.ncbi.nlm.nih.gov/pubmed/37505272
http://dx.doi.org/10.1007/s00280-023-04570-3

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10638197/
https://www.ncbi.nlm.nih.gov/pubmed/37505272
http://dx.doi.org/10.1007/s00280-023-04570-3

Ejemplares similares