Pharmacokinetics of Alisertib in Adults With Advanced Solid Tumors or Relapsed/Refractory Lymphoma With Varying Degrees of Hepatic Function

Phase 1 Completed 36 enrolled Millennium Pharmaceuticals, Inc.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the effect of moderate or severe hepatic impairment on the single-dose pharmacokinetics of alisertib in adult participants with cancer.

Timeline

Start: 2014-08-21
Primary completion: 2016-04-05
Completion: 2016-07-18

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alisertib	Small molecule	20 mg	Oral
Subject	Alisertib	Small molecule	30 mg	Oral
Subject	Alisertib	Small molecule	50 mg	Oral

Pharmacokinetics of Alisertib in Adults With Advanced Solid Tumors or Relapsed/Refractory Lymphoma With Varying Degrees of Hepatic Function

Summary

Timeline

Drugs

Indications