The phase Ib/II proof-of-concept trial will examine PXD101, a small molecule histone deacetylase (HDAC) inhibitor, in combination with Velcade (bortezomib) for the treatment of relapsed, refractory multiple myeloma, a deadly form of blood cancer. Preliminary results from this open-label, multi-center study are expected by mid-2007.
The goal of the phase Ib portion of this trial is to establish the maximum tolerated dose (MTD) of PXD101 in combination with Velcade, a Millennium Pharmaceuticals and Johnson & Johnson drug, in up to 30 patients who have failed at least two prior lines of therapy for multiple myeloma.
Following determination of the MTD, the study will enter phase II and enroll up to 15 additional patients with relapsed, refractory multiple myeloma who have failed at least one prior therapy. The phase II portion of the study will further evaluate the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of PXD101 in combination with Velcade. Patients will be enrolled at multiple sites in the US.