Study of MLN4924 in Adult Patients With Nonhematologic Malignancies

Summary

This study is an open-label, multicenter, Phase 1, dose escalation study of MLN4924 in adult patients with nonhematologic malignancies. This study will be the first to administer MLN4924 in humans. The patient population will consist of adults with any form of nonhematologic malignancy for which standard, curative, life prolonging, or palliative treatment does not exist or is no longer effective.

Timeline

Start

2008-04

Primary completion

2012-02

Completion

2012-12

Publications

• Fu DJ, Wu YJ, Chen C, Zhang C, Su ZQ, Wang T. Pevonedistat targeting NEDDylation activating enzyme for human diseases: Underlying mechanisms, clinical studies, and future directions. Pharmacol Res. 2026 Mar;225:108134. doi: 10.1016/j.phrs.2026.108134. Epub 2026 Feb 11.
• Faessel HM, Mould DR, Zhou X, Faller DV, Sedarati F, Venkatakrishnan K. Population pharmacokinetics of pevonedistat alone or in combination with standard of care in patients with solid tumours or haematological malignancies. Br J Clin Pharmacol. 2019 Nov;85(11):2568-2579. doi: 10.1111/bcp.14078. Epub 2019 Sep 4.
• Swords RT, Watts J, Erba HP, Altman JK, Maris M, Anwer F, Hua Z, Stein H, Faessel H, Sedarati F, Dezube BJ, Giles FJ, Medeiros BC, DeAngelo DJ. Expanded safety analysis of pevonedistat, a first-in-class NEDD8-activating enzyme inhibitor, in patients with acute myeloid leukemia and myelodysplastic syndromes. Blood Cancer J. 2017 Feb 3;7(2):e520. doi: 10.1038/bcj.2017.1. No abstract available.

Drugs

Indications