This trial is the first follow-on study to Genta's phase III trial of Genasense plus dacarbazine that showed benefit across multiple clinical endpoints in patients with advanced melanoma who had not previously received chemotherapy.
The new study represents the rapid clinical translation of preclinical results that demonstrated marked anticancer synergy when Genasense was combined with Abraxis Oncology's Abraxane and Schering Plough's Temodar. Both of these chemotherapy agents have recently entered phase III clinical trials in patients with advanced melanoma.
The new pilot study will evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of the three-drug combination in chemotherapy-naive patients whom have normal levels of a key biomarker, serum lactate dehydrogenase. Several dosing schedules will be examined in order to develop a regimen that may optimize safety and efficacy for additional testing.