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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01019161
First received: November 23, 2009
Last updated: October 19, 2010
Last verified: October 2010
History of Changes
  Purpose

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 Intervention Phase
Acute Myeloid Leukaemia
 Drug: AZD1152
Drug: C14 AZD1152
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Electrocardiogram (ECG) parameters [ Time Frame: Screening, PD Day 1, Day 4 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: November 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01019161

Locations
United Kingdom
Research Site
Manchester, United Kingdom
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Mike Dennis, MD The Christie Hospital, UK
  More Information

No publications provided

Responsible Party: MSD, AstraZeneca
ClinicalTrials.gov Identifier: NCT01019161     History of Changes
Other Study ID Numbers: D1531C00012
Study First Received: November 23, 2009
Last Updated: October 19, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Keywords provided by AstraZeneca:
Acute Myeloid Leukaemia (AML)
AML
AZD1152
Pharmacokinetics

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

ClinicalTrials.gov processed this record on May 23, 2013