Safety, Tolerability, PK and Efficacy of AZD1152 in Patients With Relapsed Acute Myeloid Leukemia

A Phase I/II, Open Label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of AZD1152 in Patients With Acute Myeloid Leukaemia.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00497991

Enrollment

Registered

2007-07-09

Start date

2006-05-31

Completion date

2010-04-30

Last updated

2010-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myeloid Leukemia

Keywords

AML, phase I/II, AZD1152, Acute Myeloid Leukaemia

Brief summary

The purpose of this study is to assess safety and tolerability of multiple ascending doses of AZD1152 and to assess effect of AZD1152 on the rate of complete remission in patients with relapsed acute myeloid leukaemia.

Interventions

DRUGAZD1152

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Relapsed or refractory AML for which no standard therapies are anticipated to result in durable remission * Newly diagnosed AML who are not considered suitable for other treatments.

Exclusion criteria

* Previous myeloablative therapy allogeneic bone marrow or stem cell transplantation, radiotherapy or chemotherapy within 4 weeks of first dose. * Participation in any other trial with an investigational product within the previous 30 days * Other active malignancy.

Design outcomes

Primary

Measure	Time frame
To assess the safety and tolerability of multiple ascending doses AZD1152 in patients with AML by assessment of AEs, vital signs, ECG parameters, clinical chemistry, haematology (including clotting parameters) and urinalysis.	Assessed at each visit
To determine the rate of complete remission from baseline changes in bone marrow and blood myeloblast counts and recovery of normal haemopoiesis	Change from baseline

Secondary

Measure	Time frame
To determine the pharmacokinetics, pharmacodynamics, efficacy, safety and tolerability	Assessed at each visit

Countries

France, Italy, Netherlands, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026