BAY 1238097 / Bayer - LARVOL DELTA

First-in-human phase I study of the bromodomain and extraterminal motif inhibitor BAY 1238097: emerging pharmacokinetic/pharmacodynamic relationship and early termination due to unexpected toxicity. (PubMed, Eur J Cancer) - P1 | "The study was prematurely terminated because of the occurrence of DLTs at a dose below targeted drug exposure. Pharmacokinetic modelling indicated that an alternate dosing schedule whereby DLTs could be avoided while reaching efficacious exposure was not feasible. Registration number: NCT02369029."

Biomarker • Journal • P1 data • PK/PD data • Back Pain • Fatigue • Oncology • Pain