Belinostat enters Ph II thymic carcinoma trial

Copenhagen, Denmark-based TopoTarget AS and USA-based CuraGen have initiated patient dosing in a Phase II open-label, multicenter clinical trial evaluating the efficacy and safety of intravenous belinostat, a small-molecule histone deacetylase inhibitor, for the treatment of patients with previously-treated thymoma and thymic carcinoma.

This trial is being sponsored by the US National Cancer Institute under a Clinical Trials Agreement with CuraGen for belinostat. Patients with either thymoma or thymic carcinoma who have received at least one prior platinum-containing chemotherapy regimen are eligible for enrollment. It utilizes a Simon 2-stage design and is expected to recruit up to 33 patients who will receive belinostat administered by intravenous infusion 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 by Response Evaluation Criteria in Solid Tumors guidelines. Secondary endpoints include evaluation of the time to response, duration of response, progression-free and overall survival, and the safety profile of belinostat.