AML Clinical Trial
Official title:
A Phase I/II Study of CP-4055 in Patients With Refractory/Relapsed Hematologic Malignancies
Patients with refractory or relapsed hematologic malignancies will receive CP-4055 intravenously(IV) on Day 1-5 every three weeks until complete response or disease worsening/progressing
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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