Phase I AZD2171 in Patients With Relapsed or Refractory AML and Elderly Patients With DeNovo or Secondary AML

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: NCT00502385
Recruitment Status : Completed
First Posted : July 17, 2007
Last Update Posted : January 21, 2011
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Brief Summary:
The study will be conducted across multiple European centres to assess the safety and tolerability of multiple doses of AZD2171 in patients with AML.

Condition or disease Intervention/treatment Phase
Leukaemia Myelocytic Acute Drug: AZD2171 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2004

Primary Outcome Measures :
  1. The primary objective is to determine the safety and tolerability of multiple oral doses of AZD2171 in AML patients by assessment of AEs, BP&pulse, heart rate respiration rate, EKG, clinical chemistry

Secondary Outcome Measures :
  1. Efficacy, PK

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Provision of written informed consent
  • Male/female, 18 yrs or over
  • WHO performance status 0-2
  • Disease not responding to or relapsing after chemotherapy or elderly patients not suited to chemotherapy

Exclusion Criteria:

  • Acute myeloid leukaemia arising from previous chronic myeloid leukaemia or acute myeloid leukaemia of type FAB M3
  • Previous treatment against new blood vessel formation (anti-angiogenic)
  • Chest X-ray showing leukaemia in the lungs

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): NCT00502385

Sponsors and Collaborators
Study Director: Nick Botwood, BSc, MBBS, MRCP, MFPM AstraZeneca
Principal Investigator: Dieter Hoelzer, MD, PhD Frankfurt University Hospital Identifier: NCT00502385     History of Changes
Other Study ID Numbers: D8480C00002
First Posted: July 17, 2007    Key Record Dates
Last Update Posted: January 21, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Phase I
de novo or secondary AML

Additional relevant MeSH terms:
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action