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

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.

• Authors: Anne M Traynor, Michael S Gordon, Dona Alberti, David S Mendelson, Mark S Munsey, George Wilding, Richard E Gammans, William L Read
• Journal: Investigational new drugs (Invest New Drugs) Vol. 28 Issue 4 Pg. 509-15 (Aug 2010) ISSN: 1573-0646 [Electronic] United States
• PMID: 19434370 (Publication Type: Clinical Trial, Phase I, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents
• Benzimidazoles
• Tubulin Modulators
• denibulin

Topics

• Adult
• Aged
• Antineoplastic Agents (administration & dosage, adverse effects)
• Benzimidazoles (administration & dosage, adverse effects)
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Drug Resistance, Neoplasm (drug effects)
• Female
• Humans
• Male
• Maximum Tolerated Dose
• Middle Aged
• Neoplasms (drug therapy)
• Tubulin Modulators (administration & dosage, adverse effects)