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A Phase I, Open Label, Multi-Centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD1152 in Japanese Patients With Acute Myeloid Leukaemia

A Phase I, Open Label, Multi-Centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD1152 in Japanese Patients With Acute Myeloid Leukaemia

Status
Unknown
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080220498
Enrollment
Unknown
Registered
2008-01-09
Start date
2008-01-09
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Myeloid Leukaemia

Interventions

investigational material(s) Generic name etc : AZD1152 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026