Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Leukaemia, Myelocytic, Acute
Both
Leukaemia, Myelocytic, Acute
Trial Information
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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
Principal Investigator
Nick Botwood, BSc, MBBS, MRCP, MFPM
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
D8480C00002
NCT ID:
NCT00502385
Start Date:
April 2004
Completion Date:
Related Keywords:
- Leukaemia
- Myelocytic
- Acute
- Phase I
- AML
- de novo or secondary AML
- AZD2171
- Leukemia
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