Safety, Tolerability, PK and Efficacy of AZD1152 in Patients With Relapsed Acute Myeloid Leukemia
Phase 1
Completed
- Conditions
- Myeloid Leukemia
- Registration Number
- NCT00497991
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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. 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 Change from baseline
- Secondary Outcome Measures
Name Time Method To determine the pharmacokinetics, pharmacodynamics, efficacy, safety and tolerability Assessed at each visit
Trial Locations
- Locations (1)
Research Site
🇳🇱Rotterdam, Netherlands