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)

AstraZeneca

Status and phase: Terminated; Phase 1

Conditions: Acute Myelogenous Leukemia

Treatments: Drug: AZD4877

Study type: Interventional

Funder types: Industry

Identifiers

NCT00486265

D2782C00007

Details and patient eligibility

About

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

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)