A Dose Escalation and Expansion Study of ASP4132 to Subjects With Advanced Refractory Tumors and Lymphoma

Phase 1 Completed 39 enrolled Astellas Pharma Global Development, Inc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the safety and tolerability of ASP4132 and to determine the maximum tolerated dose and recommended phase 2 dose of ASP4132. The study will also determine the pharmacokinetics (PK) of ASP4132 and evaluate the preliminary antitumor activity.

Timeline

Start: 2015-03-23
Primary completion: 2018-04-27
Completion: 2018-04-27

Publications

Janku F, LoRusso P, Mansfield AS, Nanda R, Spira A, Wang T, Melhem-Bertrandt A, Sugg J, Ball HA. First-in-human evaluation of the novel mitochondrial complex I inhibitor ASP4132 for treatment of cancer. Invest New Drugs. 2021 Oct;39(5):1348-1356. doi: 10.1007/s10637-021-01112-7. Epub 2021 Apr 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ASP4132	Unknown	5 mg	Oral
Subject	ASP4132	Unknown	7.5 mg	Oral
Subject	ASP4132	Unknown	10 mg	Oral
Subject	ASP4132	Unknown	15 mg	Oral

A Dose Escalation and Expansion Study of ASP4132 to Subjects With Advanced Refractory Tumors and Lymphoma

Summary

Timeline

Publications

Drugs

Indications