Safety, Tolerability and PK of AZD1152 in Patients With Relapsed Acute Myeloid Leukaemia (AML)

This study is currently recruiting participants.

Verified by AstraZeneca, August 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00530699

Purpose

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	Intervention	Phase
Acute Myeloid Leukaemia	Drug: AZD1152	Phase I

MedlinePlus related topics: Leukemia, Adult Acute Leukemia, Adult Chronic

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase I, Open Label, Multi-Centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD1152 in Japanese Patients With Acute Myeloid Leukaemia.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To assess the safety and tolerability of AZD1152 in patients with AML by assessment of AEs, vital signs, ECG parameters, clinical chemistry, haematology (including clotting parameters) and urinalysis [ Time Frame: assessed at each visit ]

Secondary Outcome Measures:

To examine the pharmacokinetics of AZD1152 [ Time Frame: assessed after dose administration ]

Estimated Enrollment:	30
Study Start Date:	November 2007
Estimated Study Completion Date:	June 2009

Intervention Details:

intravenous

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subjects must be in first, second or third relapse at least one month after completion of initial course of induction and consolidation therapy (may include autologous transplant but not allogenic stem cell transplantation)
Newly diagnosed Acute Myeloid Leukemia who are not considered suitable for other treatments.

Exclusion Criteria:

Previous myeloablative therapy with autologous or allogenic 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530699

Contacts

Contact: AstraZeneca Clinical Information Center	1/800-236-9933	information.center@astrazeneca.com
Contact: AstraZeneca Japan Pharmaceuticals	+81 (0)6 6453 7500

Locations

Japan
Research Site	Recruiting
FUKUOKA, Japan
Japan, AICHI
Research Site	Recruiting
NAGOYA, AICHI, Japan
Japan, FUKUI
Research Site	Recruiting
YOSHIDA-GUN, FUKUI, Japan
Japan, KANAGAWA
Research Site	Recruiting
ISEHARA, KANAGAWA, Japan
Research Site	Recruiting
YOKOHAMA, KANAGAWA, Japan
Japan, Mie
Research Site	Recruiting
Tsu, Mie, Japan
Japan, Tokyo
Research Site	Recruiting
Chuo, Tokyo, Japan

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Paul Stockman

AstraZeneca

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Japan Pharmaceuticals ( AstraZeneca )
Study ID Numbers:	D1531C00008
Study First Received:	September 13, 2007
Last Updated:	August 27, 2008
ClinicalTrials.gov Identifier:	NCT00530699
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:

Acute Myeloid Leukaemia
Phase 1
AZD1152

Study placed in the following topic categories:

Leukemia
Acute myelogenous leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Acute myelocytic leukemia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009