Leukaemia, Myelocytic, Acute
Conditions
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
Study design
Eligibility
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
| Measure | Time 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
| Measure | Time frame |
|---|---|
| Efficacy, PK | — |