Phase I/II, Open-label, Multi-center, Two Part Dose-escalation, Safety, Pharmacokinetics (PK) and Efficacy Study of AZD4877 in Patients With Acute Myelogenous Leukemia (AML)

Stopped early · Phase 1

Conditions studied: Acute Myelogenous Leukemia

In brief

The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a daily times 3 schedule in acute myelogenous leukemia (AML). For enrollment information see the Central Contact information below

Key facts

Study ID

NCT00486265

Run by

AstraZeneca

People needed

47

Starts

2007-07-01

Expected to finish

2009-07-01

Last updated by the study team

2010-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Part A: Relapsed or refractory leukemia for which no standard therapies are anticipated to result in a durable remission
• Part B: AML who have had no more than two prior relapses or failed to achieve remission after at least one induction treatment.
• Patients with prior allogeneic transplants who remain clinically stable for ≥2 weeks or more off immunosuppressive therapy

You may not qualify if…

• Promyelocytic acute myelogenous leukemia
• Prior allogeneic transplant requiring immunosuppressive therapy or treating physician does not consider patient to be a candidate for allogeneic transplantation.
• Liver injury

Where it is running

• Research Site — Chicago, Illinois, United States
• Research Site — Houston, Texas, United States
• Research Site — San Antonio, Texas, United States
• Research Site — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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