NCT00497991
Completed
Phase 1
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.
ConditionsMyeloid Leukemia
DrugsAZD1152
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Myeloid Leukemia
- Sponsor
- AstraZeneca
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
The purpose of this study is to assess safety and tolerability of multiple ascending doses of AZD1152 and to assess effect of AZD1152 on the rate of complete remission in patients with relapsed acute myeloid leukaemia.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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.
Time Frame: Assessed at each visit
To determine the rate of complete remission from baseline changes in bone marrow and blood myeloblast counts and recovery of normal haemopoiesis
Time Frame: Change from baseline
Secondary Outcomes
- To determine the pharmacokinetics, pharmacodynamics, efficacy, safety and tolerability(Assessed at each visit)
Study Sites (1)
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