A phase I study to assess the mass balance, excretion, and pharmacokinetics of [¹⁴C]-ixazomib, an oral proteasome inhibitor, in patients with advanced solid tumors.

ABSTRACT: This two-part, phase I study evaluated the mass balance, excretion, pharmacokinetics (PK), and safety of ixazomib in patients with advanced solid tumors. In Part A of the study, patients received a single 4.1 mg oral solution dose of [¹⁴C]-ixazomib containing ~500 nCi total radioactivity (TRA), followed by non-radiolabeled ixazomib (4 mg capsule) on days 14 and 21 of the 35-day PK cycle. Patients were confined to the clinic for the first 168 h post dose and returned for 24 h overnight clinic visits on days 14, 21, 28, and 35. Blood, urine, and fecal samples were collected during Part A to assess the mass balance (by accelerator mass spectrometry), excretion, and PK of ixazomib. During Part B of the study, patients received non-radiolabeled ixazomib (4 mg capsules) on days 1, 8,

SUBMITTER: Gupta N 

PROVIDER: S-EPMC5948259 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature