期刊
INVESTIGATIONAL NEW DRUGS
卷 28, 期 4, 页码 509-515出版社
SPRINGER
DOI: 10.1007/s10637-009-9264-2
关键词
Phase I; Vascular disrupting agent; Angiogenesis; Pathologic neovascularization
资金
- NCI NIH HHS [P30 CA014520-35, P30 CA014520-32, P30 CA014520-33S2, P30 CA014520-36, P30 CA014520-38, P30 CA014520-35S1, P30 CA014520, P30 CA014520-31S1, P30 CA014520-33S1, P30 CA014520-37S2, P30 CA014520-30, P30 CA014520-33, P30 CA014520-36S1, P30 CA014520-32S1, P30 CA014520-36S2, P30 CA014520-31, P30 CA014520-34, P30 CA014520-37S1, P30 CA014520-34S2, P30 CA014520-37, P30 CA014520-34S1] Funding Source: Medline
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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