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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00502385
First Posted: July 17, 2007
Last Update Posted: January 21, 2011
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.
Information provided by:
AstraZeneca
  Purpose
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 Intervention Phase
Leukaemia Myelocytic Acute Drug: AZD2171 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • Efficacy, PK

Estimated Enrollment: 54
Study Start Date: April 2004
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00502385


Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Nick Botwood, BSc, MBBS, MRCP, MFPM AstraZeneca
Principal Investigator: Dieter Hoelzer, MD, PhD Frankfurt University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00502385     History of Changes
Other Study ID Numbers: D8480C00002
First Submitted: July 13, 2007
First Posted: July 17, 2007
Last Update Posted: January 21, 2011
Last Verified: January 2011

Keywords provided by AstraZeneca:
Phase I
AML
de novo or secondary AML
AZD2171

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