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Phase I study of daily and weekly regimens of the...
Journal article

Phase I study of daily and weekly regimens of the orally administered MDM2 antagonist idasanutlin in patients with advanced tumors

Abstract

Aim The oral MDM2 antagonist idasanutlin inhibits the p53-MDM2 interaction, enabling p53 activation, tumor growth inhibition, and increased survival in xenograft models. Methods We conducted a Phase I study of idasanutlin (microprecipitate bulk powder formulation) to determine the maximum tolerated dose (MTD), safety, pharmacokinetics, pharmacodynamics, food effect, and clinical activity in patients with advanced malignancies. Schedules …

Authors

Italiano A; Miller WH; Blay J-Y; Gietema JA; Bang Y-J; Mileshkin LR; Hirte HW; Higgins B; Blotner S; Nichols GL

Journal

Investigational New Drugs, Vol. 39, No. 6, pp. 1587–1597

Publisher

Springer Nature

Publication Date

12 2021

DOI

10.1007/s10637-021-01141-2

ISSN

0167-6997