A Phase I, Open Label, Multi-Centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD1152 in Japanese Patients With Acute Myeloid Leukaemia
Phase 1
- Conditions
- Acute Myeloid Leukaemia
- Registration Number
- JPRN-jRCT2080220498
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
Ages Eligible for Study: 20 Years and older
Genders Eligible for Study: Both
Inclusion Criteria:
- Subjects must be in first, second or third relapse at least one month after completion of initial course of induction and consolidation therapy (may include autologous transplant but not allogenic stem cell transplantation)
- Newly diagnosed Acute Myeloid Luekimia who are not considered suitable for other treatments.
Exclusion Criteria
- Previous myeloablative therapy with autologous or allogenic 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
- Not specified
- Primary Outcome Measures
Name Time Method Safety Primary Outcome Measures: - To assess the safety and tolerability of AZD1152 in patients with AML by assessment of AEs, vital signs, ECG parameters, clinical chemistry, haematology (including clotting parameters) and urinalysis Secondary Outcome Measures: - To examine the pharmacokinetics of AZD1152
- Secondary Outcome Measures
Name Time Method