The primary endpoint for the study is the determination of objective disease response. Secondary endpoints include evaluation of safety and tolerability of PXD101, stable disease rates, duration of response, progression-free survival, as well as median and overall survival. PXD101 is a small molecule histone deacetylase (HDAC) inhibitor.
“This trial evaluating PXD101 monotherapy complements our ongoing phase Ib/II clinical trial, which is studying intravenous PXD101 in combination with paclitaxel and carboplatin for the treatment of advanced ovarian cancer,” stated Dr Timothy Shannon, executive vice president of R&D at CuraGen Corporation.
Correlative pharmacodynamic studies will also be conducted to evaluate the potential inhibition of HDACs in ovarian tumor cells from patients enrolled in this trial. Evaluation of the genes regulating proliferation and apoptosis, known as programmed cell death, as well as acetylation of histone and non-histone proteins, will be performed.
The trial is being sponsored by the National Cancer Institute under a clinical trials agreement with CuraGen for PXD101.