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Clinical Trials/NCT00502385
NCT00502385CompletedPhase 1

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

AstraZeneca0 sites54 target enrollmentStarted: April 2004Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
54
Primary Endpoint
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
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Outcomes

Primary Outcomes

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 Outcomes

  • Efficacy, PK

Investigators

Sponsor Class
Industry

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Phase I AZD2171 in Patients With Relapsed... | Clinical Trial