Safety, Tolerability and PK of AZD1152 in Patients With Relapsed Acute Myeloid Leukaemia (AML)

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Acute Myeloid Leukaemia

Treatments: Drug: AZD1152

Study type: Interventional

Funder types: Industry

Identifiers

NCT00530699

D1531C00008

Details and patient eligibility

About

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 who are not considered to be suitable for standard chemotherapy.

Enrollment: 30 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with relapsed or refractory AML for which no standard therapies are anticipated to result in durable remission
• Newly diagnosed Acute Myeloid Leukemia who are not considered suitable for other treatments.

Exclusion criteria

• Administration of anticancer agents (other than hydroxyurea) within 2 weeks prior to first dose of study drug, and administration of hydroxyurea within 24 hours prior to first dose of study drug
• Participation in any other trial with an investigational product within the previous 30 days.
• Uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, cardiac arrhythmia or psychiatric illness/social situations

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)