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

AstraZeneca

Status and phase: Completed; Phase 1

Conditions: Myeloid Leukemia

Treatments: Drug: AZD1152

Study type: Interventional

Funder types: Industry

Identifiers

NCT00497991

EUDRACT number 2005-004243-65

D1531C00007

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.

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)