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
20 Years
N/A
20 Years
N/A
Not Enrolling
Both
Acute Myeloid Leukaemia
Both
Acute Myeloid Leukaemia
Trial Information
A Phase I, Open Label, Multi-centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD1152 in Japanese Patients With Acute Myeloid Leukaemia.
Inclusion Criteria:
- Patients with relapsed or refractory AML for which no standard therapies are
anticipated to result in durable remission
- Newly diagnosed Acute Myeloid Leukemia who are not considered suitable for other
treatments.
Exclusion Criteria:
- Administration of anticancer agents (other than hydroxyurea) within 2 weeks prior to
first dose of study drug, and administration of hydroxyurea within 24 hours prior to
first dose of study drug
- Participation in any other trial with an investigational product within the previous
30 days.
- Uncontrolled intercurrent illness including, but not limited to, active infection,
symptomatic congestive heart failure, cardiac arrhythmia or psychiatric
illness/social situations
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:
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
Outcome Time Frame:
assessed at each visit
Principal Investigator
Paul Stockman
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
D1531C00008
NCT ID:
NCT00530699
Start Date:
November 2007
Completion Date:
August 2009
Related Keywords:
- Acute Myeloid Leukaemia
- Acute Myeloid Leukaemia
- Phase 1
- AZD1152
- Leukemia
- Leukemia, Myeloid, Acute
- Leukemia, Myeloid
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