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

Phase 1

Completed

• Conditions: Leukaemia; Myelocytic; Acute

• Registration Number: NCT00502385
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2007-07-13
• Study First Submitted QC: 2007-07-13
• Study First Posted: 2007-07-17
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-20
• Last Update Posted: 2011-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Efficacy, PK