A First-In-Human Study of RO5503781 in Participants With Advanced Malignancies Except Leukemia

Phase 1 Completed 99 enrolled Hoffmann-La Roche

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This multicenter, open label, dose-escalating study will evaluate the safety, pharmacokinetics, pharmacodynamics, and efficacy of RO5503781, administered once daily (QD) or once weekly (QW) in participants with advanced malignancies except leukemia. Participants will receive multiple escalating oral doses in two different dosing schedules (Sch) until disease progression or unacceptable toxicity occurs.

Timeline

Start: 2011-11
Primary completion: 2014-07
Completion: 2014-07

Publications

Italiano A, Miller WH Jr, Blay JY, Gietema JA, Bang YJ, Mileshkin LR, Hirte HW, Higgins B, Blotner S, Nichols GL, Chen LC, Petry C, Yang QJ, Schmitt C, Jamois C, Siu LL. Phase I study of daily and weekly regimens of the orally administered MDM2 antagonist idasanutlin in patients with advanced tumors. Invest New Drugs. 2021 Dec;39(6):1587-1597. doi: 10.1007/s10637-021-01141-2. Epub 2021 Jun 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Idasanutlin	Small molecule	500 mg	Oral
Subject	Idasanutlin	Small molecule	1000 mg	Oral
Subject	Idasanutlin	Small molecule	3200 mg	Oral

A First-In-Human Study of RO5503781 in Participants With Advanced Malignancies Except Leukemia

Summary

Timeline

Publications

Drugs

Indications