Safety, Tolerability, PK and Efficacy of AZD1152 in Patients With Relapsed Acute Myeloid Leukemia

AstraZeneca65 enrolled

Overview

The purpose of this study is to assess safety and tolerability of multiple ascending doses of AZD1152 and to assess effect of AZD1152 on the rate of complete remission in patients with relapsed acute myeloid leukaemia.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myeloid Leukemia

Interventions

AZD1152DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Relapsed or refractory AML for which no standard therapies are anticipated to result in durable remission * Newly diagnosed AML who are not considered suitable for other treatments. Exclusion Criteria: * Previous myeloablative therapy allogeneic bone marrow or stem cell transplantation, radiotherapy or chemotherapy within 4 weeks of first dose. * Participation in any other trial with an investigational product within the previous 30 days * Other active malignancy.

Locations (10)

Research Site

New York, New York, United States

Research Site

Houston, Texas, United States

Research Site

Angers, France

Research Site

Grenoble, France

Outcomes

Primary Outcomes

To assess the safety and tolerability of multiple ascending doses AZD1152 in patients with AML by assessment of AEs, vital signs, ECG parameters, clinical chemistry, haematology (including clotting parameters) and urinalysis.

Time frame: Assessed at each visit

To determine the rate of complete remission from baseline changes in bone marrow and blood myeloblast counts and recovery of normal haemopoiesis

Time frame: Change from baseline

Secondary Outcomes

To determine the pharmacokinetics, pharmacodynamics, efficacy, safety and tolerability

Time frame: Assessed at each visit

Data from ClinicalTrials.gov

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