This trial is being sponsored by the National Cancer Institute (NCI) under a clinical trials agreement with CuraGen for PXD101, a small molecule histone deacetylase (HDAC) inhibitor.
The phase I trial is an open-label, dose-escalation study being led by Dr Thehang Luu at the Department of Medical Oncology at City of Hope in Duarte, CA. The study aims to establish the maximum tolerated dose (MTD) and safety profile of PXD101 in combination with cis-retinoic acid for patients with advanced solid tumors, which are refractory to standard therapies or for which no standard treatment exists.
Up to 24 patients will be enrolled in the study and each will receive PXD101 and cis-retinoic acid in continuous three week cycles until disease progression.
Following determination of the MTD, the study will enroll approximately ten additional patients with tumors available for biopsy in order to carry out planned molecular studies, including evaluation of apoptosis in tumor biopsies, changes in gene expression, and demonstration of upregulation of retinoic acid receptors (RAR) and retinoid X receptors (RXR) following treatment with PXD101 and cis-retinoic acid.
“This trial will evaluate the safety and potential activity, as well as the genetic changes that take place in cancer cells, following treatment with PXD101 and cis-retinoic acid,” stated Dr Luu, principal investigator.