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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00502385
Enrollment
54
Registered
2007-07-17
Start date
2004-04-30
Completion date
Unknown
Last updated
2011-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukaemia, Myelocytic, Acute

Keywords

Phase I, AML, de novo or secondary AML, AZD2171

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.

Interventions

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Efficacy, PK

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026