drugset / Trial / NCT01830816

Pharmacokinetics Study of Oral Ixazomib (MLN9708) in Relapsed/Refractory Multiple Myeloma and Advanced Solid Tumors Participants With Normal Renal Function or Severe Renal Impairment

NCT01830816

Phase 1 Completed 41 enrolled Millennium Pharmaceuticals, Inc.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to characterize the single-dose pharmacokinetic (PK) parameters of ixazomib (MLN9708) in cancer participants with either normal renal function or severe renal impairment (RI), including participants with end-stage renal disease (ESRD).

Timeline

Start
2013-09-16
Primary completion
2015-03-03
Completion
2016-11-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Ixazomib Unknown 2.3 mg Oral
Subject Ixazomib Unknown 3 mg Oral
Subject Ixazomib Unknown 4 mg Oral

Indications