Investigational New Drugs

, Volume 28, Issue 4, pp 509–515

A dose escalation, safety, and tolerability study of MN-029 in patients with advanced solid tumors

  • Anne M. Traynor
  • Michael S. Gordon
  • Dona Alberti
  • David S. Mendelson
  • Mark S. Munsey
  • George Wilding
  • Richard E. Gammans
  • William L. Read
PHASE I STUDIES

DOI: 10.1007/s10637-009-9264-2

Cite this article as:
Traynor, A.M., Gordon, M.S., Alberti, D. et al. Invest New Drugs (2010) 28: 509. doi:10.1007/s10637-009-9264-2

Summary

Purpose: To assess the maximum-tolerated dose (MTD), dose-limiting toxicity (DLT), safety, and tolerability of MN-209, a novel vascular disrupting agent, in patients with advanced solid tumors. Study Design: MN-029 was administered weekly for three consecutive weeks out of four; two cycles were planned. Dose escalation proceeded by 100% per toxicity criteria. Intra-patient dose escalation was permitted. Results: Twenty patients received a total of 151 infusions of MN-029. No DLTs or grade 4 toxicities occurred. The most common adverse events were nausea, vomiting, arthralgias, and headache. One patient developed acute substernal chest pain 4 days after his first dose of MN-029 and was removed from the study. An MTD was not determined. The recommended phase II dose was identified as 180 mg/m2/week. One patient with advanced pancreatic cancer attained a partial response lasting 10 weeks. Conclusions: MN-029 was well tolerated in this schedule. Further development of this class of agents is warranted, especially in combination with other anti-cancer treatments.

Keywords

Phase IVascular disrupting agentAngiogenesisPathologic neovascularization

Copyright information

© Springer Science+Business Media, LLC 2009

Authors and Affiliations

  • Anne M. Traynor
    • 1
  • Michael S. Gordon
    • 2
  • Dona Alberti
    • 1
  • David S. Mendelson
    • 2
  • Mark S. Munsey
    • 3
  • George Wilding
    • 1
  • Richard E. Gammans
    • 3
  • William L. Read
    • 4
  1. 1.Paul P. Carbone Comprehensive Cancer CenterUniversity of WisconsinMadisonUSA
  2. 2.Premiere Oncology of ArizonaScottsdaleUSA
  3. 3.MediciNova, Inc.San DiegoUSA
  4. 4.Rebecca and John Moores Cancer CenterUniversity of California at San DiegoSan DiegoUSA