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

Phase 1

Completed

• Conditions: Acute Myeloid Leukaemia
• Interventions: Drug: AZD1152; Drug: C14 AZD1152

• Registration Number: NCT01019161
• Lead Sponsor: AstraZeneca

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-23
• Study First Submitted QC: 2009-11-23
• Study First Posted: 2009-11-25
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-19
• Last Update Posted: 2010-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AZD1152	AZD1152	100 mg Lyophile 5 mL Diluent
C14 AZD1152	C14 AZD1152	AZD1152 radiolabelled IV solution. 1.05 mg/ml will be presented as a 15 ml fill in a 20 ml vial.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇬🇧 Manchester, United Kingdom