Clinical trial · Interventional
Study to Assess the Safety and Tolerability of AZD1152 in Combination With Low Dose Cytosine Arabinoside (LDAC)
A Phase I, Open-label, Multi-centre, Multiple Ascending Dose Study to Assess the Safety and Tolerability of AZD1152 in Combination With Low Dose Cytosine Arabinoside (LDAC) in Patients With Acute Myeloid Leukaemia (AML)
NCT00926731CI-TRIAL-00005027completedPhase 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)
A study to assess the safety and tolerability of AZD1152 in combination with low dose cytosine arabinoside (LDAC) in patients with acute myeloid leukaemia (AML). The first three patients to complete a 28 day cycle in the cohort, before the second three patients start treatment.
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 Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AZD1152 | Drug | Barasertib | ALIAS |
| LDAC (low dose cytosine arabinoside) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- AZD1152 variable dose in combination with 20 mg of LDAC. (The LDAC is given twice daily.)
- interventionNames
- Drug: AZD1152
- Drug: LDAC (low dose cytosine arabinoside)
Primary outcomes (1)
- measure
- Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology and Urinalysis
- timeFrame
- Information on these will be collected from the time of informed consent is signed, throughout the study.
Secondary outcomes (1)
- measure
- Assessment of the pharmacokinetics of AZD1152, its active moiety AZD1152 hQPA, and LDAC.
- timeFrame
- During the first treatment cycle for AZD1152, pre-dose and Days 2, 3,7, 8, 9, 10, 15 and 22. For LDAC, Days 7 and 10.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed patient. * Provision of written informed consent. * De Novo (primary) or Secondary AML. * Not eligible for intensive induction chemotherapy because of medical, social or psychological reasons. Exclusion Criteria: * Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia (APL). * Patients with blast crisis of chronic myeloid leukaemia. * Persistent, chronic, clinically significant toxicities from any prior anti- cancer therapy greater than CTCAE Grade 1 (except alopecia).
References
Publications (2)
- DERIVEDKantarjian HM, Sekeres MA, Ribrag V, Rousselot P, Garcia-Manero G, Jabbour EJ, Owen K, Stockman PK, Oliver SD. Phase I study assessing the safety and tolerability of barasertib (AZD1152) with low-dose cytosine arabinoside in elderly patients with AML. Clin Lymphoma Myeloma Leuk. 2013 Oct;13(5):559-67. doi: 10.1016/j.clml.2013.03.019. Epub 2013 Jun 10. PMID 23763917
- DERIVEDQuintas-Cardama A, Ravandi F, Liu-Dumlao T, Brandt M, Faderl S, Pierce S, Borthakur G, Garcia-Manero G, Cortes J, Kantarjian H. Epigenetic therapy is associated with similar survival compared with intensive chemotherapy in older patients with newly diagnosed acute myeloid leukemia. Blood. 2012 Dec 6;120(24):4840-5. doi: 10.1182/blood-2012-06-436055. Epub 2012 Oct 15. PMID 23071272