The initial goal of this proof-of-concept phase Ib trial is to establish the maximum tolerated dose of PXD101 used in combination with carboplatin and/or paclitaxel, two drugs widely used in the treatment of ovarian and other cancers, in up to 30 patients with advanced solid tumors.
Following the determination of the maximum tolerated dose, the study will be expanded and enroll up to 15 additional ovarian cancer patients in need of relapse treatment, in order to further evaluate the safety and activity of PXD101 combined with carboplatin and/or paclitaxel. Preliminary results from this trial are expected in the fourth quarter of 2006.
“PXD101 has shown activity against human ovarian cancer cells in laboratory studies. Based upon these results, we are very interested in evaluating the role of this HDAC inhibitor, in combination with other active agents, for patients with refractory ovarian cancer,” stated Dr Johann De Bono, principal investigator and consultant medical oncologist at The Institute of Cancer Research and Royal Marsden Hospital, UK. “The ability to enhance the anti-tumor effect of the current treatment regimens by PXD101, without adding overlapping toxicities, could have a significant impact on the treatment of this disease,” he added.