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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00497991
Recruitment Status : Completed
First Posted : July 9, 2007
Last Update Posted : December 8, 2010
Information provided by:

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 Type : Interventional  (Clinical Trial)
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 2006
Primary Completion Date : October 2009
Study Completion Date : April 2010

Primary Outcome Measures :
  1. 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 ]
  2. 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 :
  1. To determine the pharmacokinetics, pharmacodynamics, efficacy, safety and tolerability [ Time Frame: Assessed at each visit ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00497991

United States, New York
Research Site
New York, New York, United States
United States, Texas
Research Site
Houston, Texas, United States
Research Site
Angers Cedex, France
Research Site
Grenoble Cedex, France
Research Site
Le Chesnay Cedex, France
Research Site
Bologna, Italy
Research Site
Roma, Italy
Research Site
Amsterdam, Netherlands
Research Site
Nijmegen, Netherlands
Research Site
Rotterdam, Netherlands
Sponsors and Collaborators
Study Director: Paul Stockman, MD AstraZeneca
Principal Investigator: Bob Lowenberg, MD, PhD Cancer Institute

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00497991     History of Changes
Other Study ID Numbers: D1531C00007
EUDRACT number 2005-004243-65
First Posted: July 9, 2007    Key Record Dates
Last Update Posted: December 8, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
phase I/II
Acute Myeloid Leukaemia

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type