Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00405743
Status:
COMPLETED
Last Update Posted:
2013-09-18
First Post:
2006-11-29
Brief Title:
A Phase III Study of CP-4055 in Patients With RefractoryRelapsed Hematologic Malignancies
Sponsor:
Clavis Pharma
Organization:
Clavis Pharma
Study Overview
Official Title:
A Phase III Study of CP-4055 in Patients With RefractoryRelapsed Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with refractory or relapsed hematologic malignancies will receive CP-4055 intravenouslyIV on Day 1-5 every three weeks until complete response or disease worseningprogressing
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 refractoryrelapsed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None