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A dose escalation, safety, and tolerability study of MN-029 in patients with advanced solid tumors
Anne M Traynor1, Michael S Gordon, Dona Alberti
1Paul P. Carbone Comprehensive Cancer Center, University of Wisconsin, K6/568 CSC, #5669, 600 Highland Avenue, Madison, WI 53792, USA. amt@medicine.wisc.edu
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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