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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01019161
Recruitment Status : Completed
First Posted : November 25, 2009
Last Update Posted : October 20, 2010
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukaemia Drug: AZD1152 Drug: C14 AZD1152 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : November 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Arm Intervention/treatment
Experimental: AZD1152
100 mg Lyophile 5 mL Diluent
Drug: AZD1152
100mg Lyophile, 5mL Diluent IV infusion
Experimental: C14 AZD1152
AZD1152 radiolabelled IV solution. 1.05 mg/ml will be presented as a 15 ml fill in a 20 ml vial.
Drug: C14 AZD1152
radiolabelled IV solution, 1.05 mg/ml presented as 15 ml fill in 20ml vial infusion

Primary Outcome Measures :
  1. 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 [ Time Frame: Day1-10 ]
  2. The derived plasma and urinary pharmacokinetic parameters for AZD1152 and AZD1152 hQPA The percentage of the [14C] AZD1152 dose recovered in urine, faeces and vomit (if presented), and the percentage of radioactive dose recovered overall. [ Time Frame: Day1-10 ]

Secondary Outcome Measures :
  1. Adverse events (AEs), serious adverse events (SAEs) and deaths, Discontinuations for tolerability reasons, vital signs (temperature, blood pressure [BP], pulse rate and respiratory rate [RR]) [ Time Frame: AEs, SAEs, deaths, discontinuations ongoing to completion and vitals over 22 days - Screening, PD Day 1, Days 3, 6, 9, 14, 22 ]
  2. Electrocardiogram (ECG) parameters [ Time Frame: Screening, PD Day 1, Day 4 ]
  3. Clinical chemistry, haematology (including clotting parameters) and urinalysis; physical examination [ Time Frame: Chemistry/Heamatology - Screening, PD Day 1, Days 3, 6, 9, 14, 22Urinalysis - Screening, PD Day 1 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01019161

United Kingdom
Research Site
Manchester, United Kingdom
Sponsors and Collaborators
Principal Investigator: Mike Dennis, MD The Christie Hospital, UK

Responsible Party: MSD, AstraZeneca Identifier: NCT01019161     History of Changes
Other Study ID Numbers: D1531C00012
First Posted: November 25, 2009    Key Record Dates
Last Update Posted: October 20, 2010
Last Verified: October 2010

Keywords provided by AstraZeneca:
Acute Myeloid Leukaemia (AML)

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type