Back to resultsAn Open Label, Single Centre Mass Balance C14 Study in Patients With Acute Myeloid Leukaemia (AML)
Primary Purpose
Acute Myeloid Leukaemia
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
AZD1152
C14 AZD1152
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukaemia focused on measuring Acute Myeloid Leukaemia (AML), AML, AZD1152, Pharmacokinetics
Eligibility 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)
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
AZD1152
C14 AZD1152
Arm Description
100 mg Lyophile 5 mL Diluent
AZD1152 radiolabelled IV solution. 1.05 mg/ml will be presented as a 15 ml fill in a 20 ml vial.
Outcomes
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
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.
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])
Electrocardiogram (ECG) parameters
Clinical chemistry, haematology (including clotting parameters) and urinalysis; physical examination
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01019161
Brief Title
An Open Label, Single Centre Mass Balance C14 Study in Patients With Acute Myeloid Leukaemia (AML)
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 Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukaemia
Keywords
Acute Myeloid Leukaemia (AML), AML, AZD1152, Pharmacokinetics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AZD1152
Arm Type
Experimental
Arm Description
100 mg Lyophile 5 mL Diluent
Arm Title
C14 AZD1152
Arm Type
Experimental
Arm Description
AZD1152 radiolabelled IV solution. 1.05 mg/ml will be presented as a 15 ml fill in a 20 ml vial.
Intervention Type
Drug
Intervention Name(s)
AZD1152
Intervention Description
100mg Lyophile, 5mL Diluent IV infusion
Intervention Type
Drug
Intervention Name(s)
C14 AZD1152
Intervention Description
radiolabelled IV solution, 1.05 mg/ml presented as 15 ml fill in 20ml vial infusion
Primary Outcome Measure Information:
Title
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
Title
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 Measure Information:
Title
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
Title
Electrocardiogram (ECG) parameters
Time Frame
Screening, PD Day 1, Day 4
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mike Dennis, MD
Organizational Affiliation
The Christie Hospital, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
An Open Label, Single Centre Mass Balance C14 Study in Patients With Acute Myeloid Leukaemia (AML)
We'll reach out to this number within 24 hrs