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
It is intended that patients receive a minimum of two cycles of therapy in the absence of
unacceptable toxicity or significant disease progression.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I: Determine the MTD and PK properties of CP-4055 single agent.
Francis J Giles, MD
Institute for Drug Development (IDD), Cancer Therapy and Research Center, San Antonio, Texas, USA
United States: Food and Drug Administration
|MD Anderson Cancer Center||Houston, Texas 77030-4096|
|Cleveland Clinic Taussig Cancer Center||Cleveland, Ohio 44195|
|Mew York Medical College, Division of Oncology||Valhalla, New York 10595|
|Duke University Medical Center (DUMC)||Durham, North Carolina 27710|
|Institute for Drug Development (IDD), Cancer Therapy and Research Center, 7979 Wurzbach Rd.||San Antonio, Texas 78229|