Phase 1 dose-escalation study of IV ixazomib, an investigational proteasome inhibitor, in patients with relapsed/refractory lymphoma

Blood Cancer J. 2014 Oct 17;4(10):e251. doi: 10.1038/bcj.2014.71.

Abstract

Ixazomib is an investigational proteasome inhibitor that has shown preclinical activity in lymphoma models. This phase 1 study assessed the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics, pharmacodynamics and preliminary activity of intravenous (IV) ixazomib in relapsed/refractory lymphoma patients who had received ⩾ 2 prior therapies. Thirty patients with a range of histologies received ixazomib 0.125-3.11 mg/m(2) on days 1, 8 and 15 of 28-day cycles. Patients received a median of two cycles (range 1-36). MTD was determined to be 2.34 mg/m(2). Most common drug-related adverse events (AEs) included fatigue (43%), diarrhea (33%), nausea, vomiting and thrombocytopenia (each 27%). Drug-related grade ⩾ 3 AEs included neutropenia (20%), thrombocytopenia (13%) and diarrhea (10%). Drug-related peripheral neuropathy occurred in four (13%) patients; no grade ⩾ 3 events were reported. Plasma exposure increased dose proportionally from 0.5-3.11 mg/m(2); terminal half-life was 4-12 days after multiple dosing. Of 26 evaluable patients, five achieved responses: 4/11 follicular lymphoma patients (one complete and three partial responses) and 1/4 peripheral T-cell lymphoma patients (partial response). Sustained responses were observed with ⩾ 32 cycles of treatment in two heavily pretreated follicular lymphoma patients. Results suggest weekly IV ixazomib is generally well tolerated and may be clinically active in relapsed/refractory lymphoma.

Publication types

  • Clinical Trial, Phase I
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Boron Compounds / administration & dosage*
  • Boron Compounds / adverse effects
  • Diarrhea / chemically induced
  • Diarrhea / epidemiology
  • Female
  • Glycine / administration & dosage
  • Glycine / adverse effects
  • Glycine / analogs & derivatives*
  • Humans
  • Lymphoma, Follicular / drug therapy*
  • Lymphoma, Follicular / epidemiology
  • Lymphoma, T-Cell, Peripheral / drug therapy*
  • Lymphoma, T-Cell, Peripheral / epidemiology
  • Male
  • Middle Aged
  • Neutropenia / chemically induced
  • Neutropenia / epidemiology
  • Peripheral Nervous System Diseases / chemically induced
  • Peripheral Nervous System Diseases / epidemiology
  • Proteasome Inhibitors / administration & dosage*
  • Proteasome Inhibitors / adverse effects
  • Thrombocytopenia / chemically induced
  • Thrombocytopenia / epidemiology

Substances

  • Boron Compounds
  • Proteasome Inhibitors
  • ixazomib
  • Glycine