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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00502385
First received: July 13, 2007
Last updated: January 20, 2011
Last verified: January 2011
  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
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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

No publications provided

ClinicalTrials.gov 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
AML
de novo or secondary AML
AZD2171

Additional relevant MeSH terms:
Leukemia
Neoplasms by Histologic Type
Neoplasms
Cediranib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014