MLN8237 to Treat Children With Relapsed/Refractory Solid Tumors

Phase 1 Completed 54 enrolled Children's Oncology Group National Cancer Institute (NCI) · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

RATIONALE: MLN8237 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase I/II trial is studying the side effects and best dose of MLN8237 and to see how well it works in treating young patients with relapsed or refractory solid tumors

Timeline

Start: 2008-09
Primary completion: 2011-12
Completion: 2011-12

Publications

Zhou X, Mould DR, Yuan Y, Fox E, Greengard E, Faller DV, Venkatakrishnan K. Population Pharmacokinetics and Exposure-Safety Relationships of Alisertib in Children and Adolescents With Advanced Malignancies. J Clin Pharmacol. 2022 Feb;62(2):206-219. doi: 10.1002/jcph.1958. Epub 2022 Jan 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alisertib	Small molecule	45 mg/m2	Oral
Subject	Alisertib	Small molecule	100 mg/m2	Oral

MLN8237 to Treat Children With Relapsed/Refractory Solid Tumors

Summary

Timeline

Publications

Drugs

Indications