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

NCT ID: NCT01019161

Last Updated: 2010-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-06-30

Brief Summary

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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

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Conditions

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Acute Myeloid Leukaemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AZD1152

100 mg Lyophile 5 mL Diluent

Group Type EXPERIMENTAL

AZD1152

Intervention Type DRUG

100mg Lyophile, 5mL Diluent IV infusion

C14 AZD1152

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

Group Type EXPERIMENTAL

C14 AZD1152

Intervention Type DRUG

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

Interventions

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AZD1152

100mg Lyophile, 5mL Diluent IV infusion

Intervention Type DRUG

C14 AZD1152

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

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Mike Dennis, MD

Role: PRINCIPAL_INVESTIGATOR

The Christie Hospital, UK

Locations

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Research Site

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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D1531C00012

Identifier Type: -

Identifier Source: org_study_id