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A Phase I Open, Non-randomised, Single-centre Study to Assess the Metabolism, Excretion and Pharmacokinetics of AZD1152 and AZD1152 hQPA Following Intravenous Administration of [14C]-AZD1152 in Patients With Acute Myeloid Leukaemia (AML)


Phase 1
18 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukaemia

Thank you

Trial Information

A Phase I Open, Non-randomised, Single-centre Study to Assess the Metabolism, Excretion and Pharmacokinetics of AZD1152 and AZD1152 hQPA Following Intravenous Administration of [14C]-AZD1152 in Patients With Acute Myeloid Leukaemia (AML)


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)

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The concentration of total radioactivity, AZD1152 and AZD1152 hQPA in plasma and their ratios, the concentration of total radioactivity in blood and its blood/plasma concentration ratios

Outcome Time Frame:

Day1-10

Safety Issue:

No

Principal Investigator

Mike Dennis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The Christie Hospital, UK

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

D1531C00012

NCT ID:

NCT01019161

Start Date:

November 2009

Completion Date:

June 2010

Related Keywords:

  • Acute Myeloid Leukaemia
  • Acute Myeloid Leukaemia (AML)
  • AML
  • AZD1152
  • Pharmacokinetics
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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