An Open Label, Single Centre Mass Balance C14 Study in Patients With Acute Myeloid Leukaemia (AML)

AstraZeneca

Status and phase

Completed

Phase 1

Conditions

Acute Myeloid Leukaemia

Treatments

Drug: C14 AZD1152

Drug: AZD1152

Study type

Interventional

Funder types

Industry

Identifiers

D1531C00012

Details and patient eligibility

About

The purpose of the study is to assess how AZD1152 is absorbed or excreted in and out of the body in patients with Acute Myeloid Leukaemia (AML).

Enrollment

5 patients

Sex

All

Ages

18+ 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. Or, patients with newly diagnosed AML who are not considered to be suitable for standard induction and consolidation chemotherapy
Ability to stay in hospital for up to 9 days on the [14C] AZD1152 treatment cycle.
Subjects who have relapsed > 1 year following myeloablative therapy with allogeneic bone marrow or stem cell transplantation may be eligible if they have no or limited evidence of extensive graft-versus-host disease

Exclusion criteria

QTc interval ≥470 ms calculated from a single ECG reading or a mean of 3 ECG readings using Fridericia's or Bazett's correction
Administration of hydroxyurea to control peripheral blood counts is prohibited within 24 hours prior to first dose of study drug
Any chemotherapy or radiotherapy within 14 days prior to starting the study (not including palliative radiotherapy at focal sites)