A phase II study evaluating systemic sagopilone (ZK-EPO) treatment in patients with recurrent malignant gliomas

2083 Background: Sagopilone (ZK-EPO) is a fully synthetic epothilone that exhibits activity in MDR tumors, and has demonstrated antitumor activity in orthotopic human glioma models in vivo. This 2-arm, phase II study aims to evaluate the safety and efficacy of sagopilone in patients (pts) with pretreated, recurrent malignant glioma who have received 2 or ≥3 prior lines of therapy, respectively. Methods: Sagopilone (16 mg/m2) was administered iv for 3 h every 21 d. The primary end point was 6-month progression- free survival (PFS-6), and secondary end points were safety, toxicity, and response rate. MRI evaluations (McDonald criteria) were performed every 2 cycles and toxicity was evaluated using CTCAE 3.0. Clinical and electrophysiological tests were undertaken before the 1st and at the 3rd and 6th cycle. Data are presented from a protocoled independent analysis of ≥3-line arm. Results: A total of 15 pts with recurrent malignant gliomas (glioblastoma multiforme [n=11] or anaplastic astrocytoma [n=4]) who ...