Phase 1/1b Pharmacokinetics Study of Oral Ixazomib (MLN9708) in Relapsed/Refractory Multiple Myeloma and Advanced Solid Tumors Patients With Normal Renal Function or Severe Renal Impairment

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