A Phase I/II, Open Label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of AZD1152 in Patients With Acute Myeloid Leukaemia.
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Myeloid Leukemia
Both
Myeloid Leukemia
Trial Information
A Phase I/II, Open Label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of AZD1152 in Patients With Acute Myeloid Leukaemia.
Inclusion Criteria:
- Relapsed or refractory AML for which no standard therapies are anticipated to result
in durable remission
- Newly diagnosed AML who are not considered suitable for other treatments.
Exclusion Criteria:
- Previous myeloablative therapy allogeneic bone marrow or stem cell transplantation,
radiotherapy or chemotherapy within 4 weeks of first dose.
- Participation in any other trial with an investigational product within the previous
30 days
- Other active malignancy.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To assess the safety and tolerability of multiple ascending doses AZD1152 in patients with AML by assessment of AEs, vital signs, ECG parameters, clinical chemistry, haematology (including clotting parameters) and urinalysis.
Outcome Time Frame:
Assessed at each visit
Principal Investigator
Paul Stockman, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United States: Food and Drug Administration
Study ID:
D1531C00007
NCT ID:
NCT00497991
Start Date:
May 2006
Completion Date:
April 2010
Related Keywords:
- Myeloid Leukemia
- AML
- phase I/II
- AZD1152
- Acute Myeloid Leukaemia
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
Name | Location |
|---|---|
| Research Site | Albany, New York |
| Research Site | Abilene, Texas |
