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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: July 13, 2007
Last updated: January 20, 2011
Last verified: January 2011

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
Drug: AZD2171
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: NCT00502385

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

No publications provided Identifier: NCT00502385     History of Changes
Other Study ID Numbers: D8480C00002
Study First Received: July 13, 2007
Last Updated: January 20, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms processed this record on April 16, 2014