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Clinical Trial Summary

This is a phase 1/1b, open-label, multicenter study of oral ixazomib (MLN9708)designed to assess the pharmacokinetics (PK) of single dose ixazomib in patients with normal renal function and in patients with severe renal impairment (RI) (according to Cockcroft-Gault estimates). Twenty-eight PK-evaluable patients will be enrolled in either 1 of the 2 arms of the study.

Arm 1: (N = 12): Normal renal function (creatinine clearance [CrCl] ≥ 90 mL/min)

Arm 2: (N = 16): Severe RI (CrCl < 30 mL/min) including at least 6 patients with ESRD, defined as renal failure requiring hemodialysis


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT01830816
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 1
Start date September 24, 2013
Completion date November 18, 2016

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