In this trial, single agent SNS-595 has demonstrated disease control (defined as stable disease, partial response or complete response) in 31 of 35 patients evaluable for best response using Gog-Recist criteria. Of these 31 patients, one patient had a complete response, four patients had partial responses (two unconfirmed) and 26 patients had a best response of stable disease.
All patients enrolled in the trial have previously failed treatment with platinum-containing regimens, and fourteen of the 35 patients have also failed prior treatment with doxorubicin HCl liposome injection (Doxil). Both platinum-resistant and Doxil-resistant patients in the Phase II clinical trial have responded to SNS-595 therapy. Among 45 patients with sufficient follow-up to yield safety data, SNS-595 was generally well tolerated at a dose level of 48mg/m2 administered once every three weeks.