Comparison of baseline patient characteristics in phase 1 and phase 2/3 clinical trials for anticancer treatments
We found no statistically significant difference in age, sex and PS between patients in phase 2/3 and corresponding phase 1 CTs for anticancer treatments. Therefore, patient selection in phase 1 trials appears crucial, considering its potential impact in later development phases.
Authors
- Adriano Gravina (ORCID: https://orcid.org/0000-0002-5675-8457)
- Massimo Di Maïo (ORCID: https://orcid.org/0000-0001-8906-3785)
- Sergio Facchini (ORCID: https://orcid.org/0000-0003-0684-6683)
- Laura Arenare (ORCID: https://orcid.org/0000-0001-7100-4517)
- Pier Paolo Olimpieri (ORCID: https://orcid.org/0000-0001-7934-9034)
- Andrea Caglio
- Maria Lucia Iacovino (ORCID: https://orcid.org/0000-0001-9957-6170)
- Clorinda Schettino
- Maria Carmela Piccirillo (ORCID: https://orcid.org/0000-0001-9519-4757)
- Simone Talucci
- Flavio Salerno
- Andrea Canciello
- Francesco Perrone (ORCID: https://orcid.org/0000-0002-9738-0526)
Institutions
- Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT)
- Menarini Group (Italy) (IT)
- Italian Medicines Agency (IT)
- A. O. Ordine Mauriziano di Torino (IT)
- Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" (IT)
Publication Details
- Journal
- Journal of Translational Medicine
- Published
- 2025-05-16
- DOI
- https://doi.org/10.1186/s12967-025-06509-z
- Primary Topic
- Cancer Genomics and Diagnostics
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Ministero della Salute
- National Cancer Institute