This proof-of-concept trial will initially enroll up to 15 patients with advanced solid tumors to establish the maximum tolerated dose of PXD101 used in combination with 5-fluorouracil (5-FU), a drug widely used in the treatment of colorectal and other cancers.
Following determination of the maximum tolerated dose, the study will be expanded and enroll up to 20 additional patients with the disorder in order to further evaluate the safety and activity of PXD101 combined with 5-FU in this patient population.
In addition, the trial will assess the effect of PXD101 on thymidylate synthase (TS) expression in tumors. Patients will be enrolled at multiple sites in the US, with preliminary results expected in the fourth quarter of 2006.
“5-FU, in combination with other agents, is considered to be one of the first-line treatments for colorectal and other solid tumors. Demonstrating the ability of PXD101 to enhance the anticancer effects in combination with 5-FU could be of great benefit to patients,” stated Dr Daniel Von Hoff, FACP, senior investigator of the Translational Genomics Research Institute.