The phase I study is an open-label, multi-center trial designed to establish the maximum tolerated dose (MTD) for oral PXD101 administered once or twice daily. Patients will be treated with oral PXD101 in a dose-escalation regimen and may continue to receive up to eight or more treatment cycles depending on disease response.
Primary objectives for the study include evaluation of the safety, tolerability and pharmacokinetics of oral PXD101. Secondary objectives include assessment of the pharmacokinetic profile of oral PXD101 administered once or twice daily at various dose levels and evaluation of anti-tumor activity.
The study is being conducted at sites both in the US and Europe, with preliminary results expected to be available by the end of 2007.
This news comes just days after the two companies announced the initiation of a phase I trial evaluating the safety and tolerability of PXD101 plus zacitidine in advanced hematologic malignancies.
The intravenous formulation of PXD101 is also being evaluated in a number of other indications, with phase II trials underway in multiple myeloma, T-cell lymphomas, and acute myelogenous leukemia.