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Investigational New Drugs
Published in: Investigational New Drugs 4/2010

01-08-2010 | PHASE I STUDIES

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

Authors: Anne M. Traynor, Michael S. Gordon, Dona Alberti, David S. Mendelson, Mark S. Munsey, George Wilding, Richard E. Gammans, William L. Read

Published in: Investigational New Drugs | Issue 4/2010

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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.
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Metadata
Title
A dose escalation, safety, and tolerability study of MN-029 in patients with advanced solid tumors
Authors
Anne M. Traynor
Michael S. Gordon
Dona Alberti
David S. Mendelson
Mark S. Munsey
George Wilding
Richard E. Gammans
William L. Read
Publication date
01-08-2010
Publisher
Springer US
Published in
Investigational New Drugs / Issue 4/2010
Print ISSN: 0167-6997
Electronic ISSN: 1573-0646
DOI
https://doi.org/10.1007/s10637-009-9264-2

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