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)

• Status: Terminated
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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