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)
Phase 1
60 Years
N/A
60 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukemia
Both
Acute Myeloid Leukemia
Trial Information
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)
Inclusion Criteria:
- 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
psychological reasons.
Exclusion Criteria:
- 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:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Safety Issue:
No
Principal Investigator
Paul Stockman
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United States: Food and Drug Administration
Study ID:
D1531C00018
NCT ID:
NCT00926731
Start Date:
June 2009
Completion Date:
May 2011
Related Keywords:
- Acute Myeloid Leukemia
- Acute Myeloid Leukaemia (AML)
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
Name | Location |
|---|---|
| Research Site | Akron, Ohio |
| Research Site | Abilene, Texas |
