Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106600
Status:
COMPLETED
Last Update Posted:
2023-09-18
First Post:
2005-03-28
Brief Title:
Pixantrone BBR 2778 in Patients With Refractory Acute Myelogenous Leukemia AML
Sponsor:
CTI BioPharma
Organization:
CTI BioPharma
Study Overview
Official Title:
A Phase III Study of Pixantrone BBR 2778 in Patients With Refractory Acute Myelogenous Leukemia AML
Status:
COMPLETED
Status Verified Date:
2007-08
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:
The goal of this study is to find the safest dose of Pixantrone BBR 2778 that can be given to patients with Acute Myelogenous Leukemia AML After the safest dose is found up to an additional 86 patients will be enrolled During this part of the study the safety and effectiveness will be evaluated
Detailed Description:
This is an open label single center phase III study of pixantrone in patients with refractory AML Pixantrone will be administered for three consecutive days on days 1 2 and 3 of each 21-day cycle for up to two cycles
The study has 2 parts phase I and phase II In the phase I part of the study the maximum tolerated dose MTD for pixantrone as a single agent in patients with refractory AML will be determined In the phase II part of the study up to an additional 86 patients will be treated at the MTD to assess disease response
The study has 2 parts phase I and phase II In the phase I part of the study the maximum tolerated dose MTD for pixantrone as a single agent in patients with refractory AML will be determined In the phase II part of the study up to an additional 86 patients will be treated at the MTD to assess disease response
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