AVEO Pharmaceuticals has started patient recruitment in an open-label, multi-center Phase 1b clinical trial evaluating Tivozanib in combination with oral capecitabine (Xeloda) in patients with certain advanced solid tumors.
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AVEO Pharma claims that Tivozanib, an investigational new drug, is a highly potent and selective inhibitor of VEGF receptors 1, 2 and 3, exhibiting picomolar inhibitory activity against all three receptors.
The trial is designed to assess the safety, tolerability and maximum tolerated dose (MTD) of Tivozanib when given in combination with oral capecitabine, a chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers, in approximately 24 patients with advanced solid tumors at three US sites.
In the expansion cohort of the trial, up to 12 patients with locally advanced or metastatic breast or colorectal cancer are expected to be enrolled to further evaluate safety and activity of this combination in these tumor types.
Sarah Cannon Research Institute Drug Development director and chief medical officer Skip Burris said that combining investigational Tivozanib, which targets VEGF receptors 1, 2 and 3 and has demonstrated the potential for favorable safety and tolerability, with an oral chemotherapeutic drug like capecitabine, may offer a therapeutic advance and a convenient dosing regimen for patients with breast and colorectal cancers.
AVEO Pharma president and CEO Tuan Ha-Ngoc said that they believe this Phase 1b trial evaluating Tivozanib in combination with oral capecitabine in patients with colorectal and breast cancers may provide further evidence of Tivozanib’s utility as a valuable addition to widely used cancer treatment regimens, in addition to being an effective and tolerable monotherapy option.
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