This trial is being sponsored by the US National Cancer Institute (NCI) under an agreement with CuraGen and will be conducted at multiple sites in the US.
Up to 55 acute myelogenous leukemia (AML) patients will be enrolled in the phase II trial and will receive three week cycles of PXD101 administered by intravenous infusion. Patients demonstrating complete or partial response will continue to receive treatment with PXD101 until disease progression. The primary endpoint for the study is response rate, with secondary endpoints measuring overall survival and time to treatment failure.
The trial is an open-label study being led by Dr Kenneth Foon, director of clinical investigations at the University of Pittsburgh Cancer Institute, in collaboration with Dr Mark Kirschbaum, director of new drug development at City of Hope in Duarte, California.
“The research we have conducted on HDAC (histone deacetylase) inhibitors at City of Hope suggests that agents like PXD101 affect many of the critical pathways cancer cells use for survival,” stated Dr Kirschbaum. “Based on these intriguing results we have initiated patient treatment with PXD101 and look forward to evaluating the role of this HDAC inhibitor for the treatment of AML.”