The trial is evaluating PXD101, a small molecule histone deacetylase (HDAC) inhibitor, in combination with Millennium Pharmaceutical’s oncology drug Velcade.
This trial is being sponsored by the National Cancer Institute (NCI) under a clinical trials agreement with CuraGen for PXD101 and under a cooperative R&D agreement (CRADA) with Millennium Pharmaceuticals for Velcade.
The study aims to establish the maximum tolerated dose and safety profile of PXD101 in combination with Velcade for patients with advanced solid tumors or lymphomas, which are refractory to standard therapies or for which no standard treatment exists.
Up to 36 patients will be enrolled in the dose escalation portion of the study and receive PXD101 and Velcade in a three week cycle. Following determination of the maximum tolerated dose, the study will enroll approximately ten additional patients to further assess the biologic activity of PXD101 and Velcade against tumor cells, including inhibition of HDAC and the proteasome.
“Based on the reported preclinical findings for PXD101 and bortezomib (Velcade), these compounds appear to work through distinct pathways that are complementary to one another, and when combined, demonstrate synergistic activity against certain cancers in vitro,” stated Dr Gail Eckhardt, professor of medicine at the University of Colorado Health Sciences Center, and principle investigator.
The companies also recently initiated a phase Ib/II study of PXD101 plus Velcade for the specific treatment of multiple myeloma.