Clinical trial · Interventional
Safety, Tolerability and PK of AZD1152 in Patients With Relapsed Acute Myeloid Leukaemia (AML)
A Phase I, Open Label, Multi-centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD1152 in Japanese Patients With Acute Myeloid Leukaemia.
NCT00530699CI-TRIAL-00002614completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 who are not considered to be suitable for standard chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukaemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD1152 | Drug | Barasertib | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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
- timeFrame
- assessed at each visit
Secondary outcomes (1)
- measure
- To examine the pharmacokinetics of AZD1152
- timeFrame
- assessed after dose administration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.