FDAnews
www.fdanews.com/articles/102441-curagen-topotarget-dose-first-patients-in-belinostat-trial

CuraGen, TopoTarget Dose First Patients in Belinostat Trial

December 19, 2007

CuraGen and Denmark’s TopoTarget have begun a Phase II trial evaluating the efficacy and safety of intravenous belinostat in patients with previously treated thymoma and thymic carcinoma.

The trial is sponsored by the National Cancer Institute under a clinical trials agreement with CuraGen.

The open-label, multicenter trial will enroll up to 33 patients who will receive belinostat administered by IV once daily for five days every three weeks. Patients will continue to receive treatment with belinostat until disease progression.

The primary objective of the study is to determine the objective response rate. Secondary endpoints include evaluation of the time to response, duration of response, progression-free and overall survival, CuraGen said.