EpiCept announced that the National Cancer Institute (NCI) has initiated a Phase 2 trial with crolibulin (EPC2407) in combination with cisplatin for the treatment of anaplastic thyroid cancer (ATC). The trial consists of two stages and will enroll up to 70 patients. The primary objective of the first stage is to assess the safety and tolerability of cisplatin and crolibulin given in 21-day treatment cycles. The study will assess the toxicities of crolibulin co-administered with cisplatin, evaluate dose-limiting toxicities (DLTs) and determine the maximum tolerated dose (MTD) for the combination. The primary objective in the second stage of the trial will be to compare the combination of crolibulin and cisplatin against cisplatin alone in adult ATC patients by assessing the duration of progression-free survival (PFS). An important secondary objective is the comparison of the response rates evaluated by RECIST (Response Evaluation Criteria in Solid Tumors).
Crolibulin is a vascular disruption and apoptosis inducing agent that has demonstrated potent anti-tumor activity in both preclinical and early clinical studies.
For more information call (914) 606-3501 or visit www.epicept.com.