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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00497991

Collaborator

(none)

Enrollment

Locations

Duration (Months)

6.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myeloid Leukemia	Drug: AZD1152	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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.

Study Start Date :

May 1, 2006

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Apr 1, 2010

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

To determine the pharmacokinetics, pharmacodynamics, efficacy, safety and tolerability [Assessed at each visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Research Site	New York	New York	United States
2	Research Site	Houston	Texas	United States
3	Research Site	Angers Cedex		France
4	Research Site	Grenoble Cedex		France
5	Research Site	Le Chesnay Cedex		France
6	Research Site	Bologna		Italy
7	Research Site	Roma		Italy
8	Research Site	Amsterdam		Netherlands
9	Research Site	Nijmegen		Netherlands
10	Research Site	Rotterdam		Netherlands