NCT00405743

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Clavis Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Hematologic Malignancies
• AML

Interventions

Type	Name	Description
DRUG	CP-4055	CP-4055 Continuous IV infusion
DRUG	CP-4055	CP4055 2 and 4 hour IV infusion

Timeline

• Start date: 2006-05-01
• Primary completion: 2009-05-01
• Completion: 2010-05-01
• First posted: 2006-11-30
• Last updated: 2013-09-18

Locations

16 sites across 6 countries: United States, France, Germany, Italy, Norway, United Kingdom