EpiCept Corporation has reported that the National Cancer Institute (NCI) has initiated a Phase II trial of crolibulin (EPC2407) in patients with anaplastic thyroid cancer (ATC).
The trial is designed to evaluate the efficacy and safety of crolibulin in combination with cisplatin in patients with ATC, and will enroll up to 70 patients.
The Phase II trial comprises two stages, in which, the primary objective of the first stage will be to assess the safety and tolerability of cisplatin and crolibulin.
The study will evaluate the toxicities of crolibulin in combination with cisplatin, evaluate dose-limiting toxicities (DLTs) and determine the maximum tolerated dose (MTD) for the combination.
The primary objective of the second stage of the trial will be to compare the combination of crolibulin and cisplatin versus cisplatin alone in adult ATC patients by evaluating the duration of progression-free survival (PFS).
An important secondary objective will be to compare the response rates evaluated by RECIST (response evaluation criteria in solid tumours).
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Crolibulin is a vascular disruption and apoptosis inducing agent, which demonstrated potent anti-tumour activity in both preclinical and early clinical studies.