Erica Brivio, Edoardo Pennesi, Marieke E Willemse, Alwin D R Huitema, Yilin Jiang, Harm D R van Tinteren, Vincent H J van der Velden, Berna H Beverloo, Monique L den Boer, Lukas A J Rammeloo, Chad Hudson, Nyla Heerema, Karey Kowalski, Huadong Zhao, Luke Kuttschreuter, Francisco J Bautista Sirvent, Andrew Bukowinski, Carmelo Rizzari, Jessica Pollard, Laura Murillo-Sanjuán, Matthew Kutny, Sara Zarnegar-Lumley, Michele Redell, Stacy Cooper, Yves Bertrand, Arnaud Petit, Julie Krystal, Markus Metzler, Donna Lancaster, Jean-Pierre Bourquin, Jayashree Motwani, Inge M van der Sluis, Franco Locatelli, Michael E Roth, Nobuko Hijiya, Christian M Zwaan
PURPOSE: Bosutinib is approved for adults with chronic myeloid leukemia (CML): 400 mg once daily in newly diagnosed (ND); 500 mg once daily in resistant/intolerant (R/I) patients. Bosutinib has a different tolerability profile than other tyrosine kinase inhibitors (TKIs) and potentially less impact on growth (preclinical data). The primary objective of this first-in-child trial was to determine the recommended phase II dose (RP2D) for pediatric R/I and ND patients. PATIENTS AND METHODS: In the phase I part of this international, open-label trial (ClinicalTrials...
November 30, 2023: Journal of Clinical Oncology