Pixantrone (BBR 2778) in Patients With Refractory Acute Myelogenous Leukemia (AML)
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|ClinicalTrials.gov Identifier: NCT00106600|
Recruitment Status : Completed
First Posted : March 29, 2005
Last Update Posted : August 22, 2007
|Condition or disease||Intervention/treatment||Phase|
|Acute Myelogenous Leukemia||Drug: Pixantrone IV infusion||Phase 1 Phase 2|
This is an open label, single center, phase I/II 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||119 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Pixantrone (BBR 2778) in Patients With Refractory Acute Myelogenous Leukemia (AML)|
|Study Start Date :||March 2005|
|Estimated Study Completion Date :||March 2007|
- Phase I: To determine the maximum tolerated dose (MTD) of Pixantrone (BBR 2778) in patients with refractory acute myelogenous leukemia (AML)
- Phase II: To evaluate the activity of pixantrone in this patient population in terms of objective responses
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00106600
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|