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Clinical Trial
. 2010 Aug;28(4):509-15.
doi: 10.1007/s10637-009-9264-2. Epub 2009 May 13.

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

Anne M Traynor  1 , Michael S Gordon, Dona Alberti, David S Mendelson, Mark S Munsey, George Wilding, Richard E Gammans, William L Read
Affiliations
Clinical Trial

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

Anne M Traynor et al. Invest New Drugs. 2010 Aug.

Abstract

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/m(2)/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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