In this dose-escalating Phase I trial using a modified 3+3 design, MGCD265 is administered orally to patients at an initial starting dose of 24mg/m2 daily on a continuous basis for a 21-day cycle.
The purpose of this trial is to evaluate the safety, pharmacokinetics, pharmacodynamics, and the maximum tolerated dose of MGCD265 in patients with advanced metastatic or unresectable solid tumors that are refractory to standard therapy.
Clinical sites for this trial include the Dana-Farber Cancer Institute in Boston, the BC Cancer Agency in Vancouver and Duke University Medical Center in Durham.
MGCD265 is an oral, small molecule, multi-targeted kinase inhibitor that targets c-Met, VEGFR1, VEGFR2, VEGFR3, Tie-2 and Ron receptor tyrosine kinases.
Donald Corcoran, president and CEO of MethylGene, said: “We continue to make progress with our pipeline, which now includes two potential anticancer agents currently in clinical trials. In addition to our multi-targeted c-Met kinase inhibitor, MGCD265, our histone deacetylase inhibitor, MGCD0103, is also in clinical trials.”