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

NCT01019161 | Completed Phase 1

• 1 other identifier: D1531C00012
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Myeloid Leukaemia

Keywords

Acute Myeloid Leukaemia (AML); AML; AZD1152; Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• 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

  Day1-10

• 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.

  Day1-10

Secondary Outcomes (3)

• 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])

  AEs, SAEs, deaths, discontinuations ongoing to completion and vitals over 22 days - Screening, PD Day 1, Days 3, 6, 9, 14, 22

• Electrocardiogram (ECG) parameters

  Screening, PD Day 1, Day 4

• Clinical chemistry, haematology (including clotting parameters) and urinalysis; physical examination

  Chemistry/Heamatology - Screening, PD Day 1, Days 3, 6, 9, 14, 22Urinalysis - Screening, PD Day 1

Study Arms (2)

AZD1152

EXPERIMENTAL

100 mg Lyophile 5 mL Diluent

Drug: AZD1152

C14 AZD1152

EXPERIMENTAL

AZD1152 radiolabelled IV solution. 1.05 mg/ml will be presented as a 15 ml fill in a 20 ml vial.

Drug: C14 AZD1152

Interventions

AZD1152 DRUG

100mg Lyophile, 5mL Diluent IV infusion

AZD1152

C14 AZD1152 DRUG

radiolabelled IV solution, 1.05 mg/ml presented as 15 ml fill in 20ml vial infusion

C14 AZD1152

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

2-((3-((4-((5-(2-((3-fluorophenyl)amino)-2-oxoethyl)-1H-pyrazol-3-yl)amino)quinazolin-7-yl)oxy)propyl)(ethyl)amino)ethyl dihydrogen phosphate

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Mike Dennis, MD

  The Christie Hospital, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 23, 2009
• First Posted: November 25, 2009
• Study Start: November 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 20, 2010

Record last verified: 2010-10

Locations

GB (1)