BAY 1238097
/ Bayer
- LARVOL DELTA
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February 04, 2019
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
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