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CuraGen, TopoTarget Initiate Phase I/II Clinical Trial of Belinostat 

August 28, 2007

CuraGen and TopoTarget announced the initiation of patient dosing in a Phase I/II clinical trial evaluating belinostat, a histone deacetylase inhibitor, in combination with the anthracycline idarubicin for the treatment of acute myeloid leukemia (AML).

The trial is being conducted at multiple sites in the EU. Patients under the age of 60 with relapsed or refractory AML, or patients over the age of 60 with newly diagnosed or previously treated AML, are eligible to enroll in the trial, CuraGen and TopoTarget said.

According to the companies, 24 to 40 patients will be enrolled into one of two treatment arms and receive intravenous treatment with a combination of belinostat (PXD101) and idarubicin. Patients will receive standard doses of idarubicin in combination with either belinostat administered intravenously once daily for five days, or a continuous infusion of belinostat over 24 to 48 hours.

Patients demonstrating complete or partial response will continue to receive treatment with belinostat until disease progression. The primary objectives for the study include safety, tolerability and efficacy for each treatment regimen, and secondary objectives include time to response, duration of response and survival, the companies added.