A Phase I/II Study of CP-4055 in Patients With Refractory/Relapsed Hematologic Malignancies

This is a multicentre clinical study conducted in the USA and in Europe. It is an open label, dose escalation study designed to characterize the safety, tolerability, pharmacokinetics (PK), and efficacy of CP-4055 as a single agent when administered as a 2 hours intravenous (IV) or a continuous IV (CIV) infusion administered daily for 5 days in a 21-day cycle, either alone or with idarubicin IV, in patients with refractory/relapsed hematologic malignancies who have either failed potentially curative therapy or are considered unsuitable for standard therapy. In a second phase of the study the efficacy of single agent CP-4055 in patients with AML may be assessed. It is intended that patients receive a minimum of two cycles of therapy in the absence of unacceptable toxicity or significant disease progression.