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news.MethylGene has started dosing of the first patient in a Phase I clinical trial of MGCD265 in patients with solid tumor cancers.
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In this dose-escalating Phase I trial (trial 102), MGCD265 is administered orally to patients at an initial starting dose of 24mg/m2 daily on an intermittent basis (every other week) for a 28-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.
The trial is expected to enroll 20 to 60 patients and will be conducted at the Karmanos Cancer Institute in Michigan and at the MD Anderson Cancer Center in Houston. MethylGene expects to initiate a second MGCD265 Phase I clinical trial with an alternative dosing schedule in the same patient population during the second quarter of 2008.
MGCD265 is an oral, small molecule, multi-targeted kinase inhibitor that targets c-Met, VEGFR1, VEGFR2, VEGFR3, Tie-2 and Ron receptor tyrosine kinases. These kinases appear to play key roles in tumor development, tumor survival, and the inappropriate formation of blood vessels (angiogenesis) that nourish the tumor.
Donald Corcoran, president and CEO of MethylGene, said: “Because MGCD265 is multi-targeted, we are attempting to inhibit cancer with one inhibitor via several key and separate mechanisms.”