SGI-110 is a DNA-hypomethyating agent that is proven to restore silenced tumour suppressor gene expression in cancer cells by reversal of DNA methylation.
Astex chief medical officer Mohammad Azab said, "We are pleased to initiate this study which expands the investigational breadth of our development program for SGI-110 to include HCC in addition to the ongoing studies in myelodysplastic syndromes (MDS), acute myeloid leukemia (AML) and ovarian cancer," Azab added.
The open-label, single-arm, non-randomised study uses Simon’s 2-stage design.
Part A will enroll 15 patients in Stage 1 to assess the safety, disease control, and for methylation status of certain tumour suppressor genes beleived to be involved in HCC. If sucessful, Part B would enrol 31 extra patients in Stage 2.
Primary endpoint is the disease control rate at 16 weeks, defined as percentage of patients who achieve a best clinical response of complete or partial response, or stable disease at that time.
Secondary endpoints include the incidence and severity of adverse events, global DNA methylation levels, methylation status of selected tumour suppressor genes in tumour tissue, progression-free survival and overall survival.