A Phase I, Open-label, Multi-centre, Multiple Ascending Dose Study to Assess the Safety and Tolerability of AZD1152 in Combination With Low Dose Cytosine Arabinoside (LDAC) in Patients With Acute Myeloid Leukaemia (AML)
- Newly diagnosed patient.
- Provision of written informed consent.
- De Novo (primary) or Secondary AML.
- Not eligible for intensive induction chemotherapy because of medical, social or
- Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia (APL).
- Patients with blast crisis of chronic myeloid leukaemia.
- Persistent, chronic, clinically significant toxicities from any prior anti- cancer
therapy greater than CTCAE Grade 1 (except alopecia).
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology and Urinalysis
Outcome Time Frame:
Information on these will be collected from the time of informed consent is signed, throughout the study.
United States: Food and Drug Administration
- Acute Myeloid Leukemia
- Acute Myeloid Leukaemia (AML)
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
|Research Site||Akron, Ohio |
|Research Site||Abilene, Texas |