Safety, Tolerability, PK and Efficacy of AZD1152 in Patients With Relapsed Acute Myeloid Leukemia - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00497991

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 Phase II

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/Efficacy Study
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.

Further study details as provided by AstraZeneca:

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. [ Time Frame: 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 [ Time Frame: Change from baseline ]

Secondary Outcome Measures:

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

Estimated Enrollment:	70
Study Start Date:	May 2006
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00497991

Contacts

Contact: AstraZeneca Clinical Information Center	1-800-236-9933	information.center@astrazeneca.com
Contact: Outside US	001-866-992-9276

Locations

United States, New York
Research Site	Recruiting
New York, New York, United States
United States, Texas
Research Site	Recruiting
HOUSTON, Texas, United States
France
Research Site	Recruiting
ANGERS CEDEX, France
Research Site	Recruiting
GRENOBLE CEDEX, France
Research Site	Recruiting
LE CHESNAY CEDEX, France
Italy
Research Site	Recruiting
BOLOGNA, Italy
Research Site	Recruiting
ROMA, Italy
Netherlands
Research Site	Recruiting
AMSTERDAM, Netherlands
Research Site	Recruiting
NIJMEGEN, Netherlands
Research Site	Recruiting
ROTTERDAM, Netherlands

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Paul Stockman, MD	AstraZeneca
Principal Investigator:	Bob Lowenberg, MD, PhD	Cancer Institute

More Information

AstraZeneca Clinical Trial Information - Outside US This link exits the ClinicalTrials.gov site

Study ID Numbers:	D1531C00007, EUDRACT number 2005-004243-65
Study First Received:	July 5, 2007
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00497991
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

AML
phase I/II
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