Phase 1 study of ixazomib, an investigational proteasome inhibitor, in advanced non-hematologic malignancies.

ABSTRACT:

Purpose

Ixazomib is an investigational proteasome inhibitor with demonstrated antitumor activity in xenograft models of multiple myeloma (MM), lymphoma, and solid tumors. This open-label, phase 1 study investigated intravenous (IV) ixazomib, in adult patients with advanced non-hematologic malignancies.

Methods

Patients received IV ixazomib twice-weekly for up to twelve 21-day cycles. The 0.125 mg/m(2) starting dose was doubled (one patient/dose) until 1.0 mg/m(2) based on dose-limiting toxicities (DLTs) in cycle 1. This was followed by 3 + 3 dose-escalation and expansion at the maximum tolerated dose (MTD). Primary objectives included safety and MTD assessment. Secondary objectives included assessment of pharmacokinetics, pharmacodynamics, and disease response.

Results

SUBMITTER: Smith DC 

PROVIDER: S-EPMC4435632 | biostudies-literature | 2015 Jun

REPOSITORIES: biostudies-literature