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A randomised, open-label, multi-centre, 2-stage, parallel group study to assess the efficacy, safety and tolerability of AZD1152 alone and in combination with low dose cytosine arabinoside (LDAC) in comparison with LDAC alone in patients aged ≥ 60 with newly diagnosed acute myeloid leukaemia (AML) who are considered unsuitable to receive intensive induction chemotherapy regimens

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Trial Profile

A randomised, open-label, multi-centre, 2-stage, parallel group study to assess the efficacy, safety and tolerability of AZD1152 alone and in combination with low dose cytosine arabinoside (LDAC) in comparison with LDAC alone in patients aged ≥ 60 with newly diagnosed acute myeloid leukaemia (AML) who are considered unsuitable to receive intensive induction chemotherapy regimens

Status: Completed
Phase of Trial: Phase II/III

Latest Information Update: 01 Jul 2022

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At a glance

  • Drugs Barasertib (Primary) ; Cytarabine
  • Indications Acute myeloid leukaemia
  • Focus Pharmacogenomic; Therapeutic Use
  • Acronyms SPARK-AML1
  • Sponsors AstraZeneca; AstraZeneca KK

Most Recent Events

  • 28 May 2014 The number of treatment arms changed from 3 to 2. The study now comprises of 2 arms: Arm-1- AZD 11521 and Arm-2- Cytarabine. The deleted arm is: AZD 11521+Cytarabine.
  • 28 Mar 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
  • 19 Apr 2013 Results of Part I of the study (n=77) published in Cancer.

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