CuraGen Corp. and TopoTarget initiated a Phase I/II open-label, multi-center trial evaluating the efficacy and safety of intravenous belinostat (PXD101), an HDAC inhibitor, in combination with doxorubicin for the treatment of Soft Tissue Sarcomas (STS).

During the initial dose escalation part of the trial, as many as 24 patients with solid tumors for whom no standard therapy exists will be enrolled in order to define the maximal tolerated dose (MTD) of belinostat in combination with doxorubicin. Once MTD is established, the trial will advance into Phase II and enroll an additional 20 to 40 STS patients who have not received prior chemotherapy. Patients will receive their standard chemotherapy of doxorubicin every three weeks and belinostat will be added in a five-day intravenous regimen. Patients demonstrating complete or partial response will continue to receive treatment with the combination for up to eight cycles or until disease progression.

The primary objectives for the study are to determine the MTD and to assess the anti-tumor activity of belinostat and doxorubicin combination treatment as defined by RECIST criteria. Secondary objectives include the time to disease progression, overall survival, and duration of response. The pharmacokinetic profile and aspects of pharmacodynamic activity of belinostat will also be evaluated.