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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00952588
Registration number
NCT00952588
Ethics application status
Date submitted
4/08/2009
Date registered
6/08/2009
Date last updated
24/02/2020
Titles & IDs
Public title
Study to Investigate the Efficacy, Safety and Tolerability of AZD1152 Alone and in Combination With Low Dose Cytosine Arabinoside (LDAC)in Acute Myeloid Leukaemia (AML) Patients
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Scientific title
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)
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Secondary ID [1]
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D1531C00009
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Universal Trial Number (UTN)
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Trial acronym
SPARK-AML1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Myeloid Leukemia
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - AZD1152
Treatment: Drugs - LDAC
Experimental: AZD1152 1200 mg - AZD1152 1200 mg, iv, 7 day infusion monotherapy
Active Comparator: LDAC 20 mg - LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
Treatment: Drugs: AZD1152
1200 mg, iv, 7 day infusion
Treatment: Drugs: LDAC
20 mg, sc, bd, 10 days
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Patients With Overall Complete Response for Stage I
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Assessment method [1]
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Percentage of patients achieving either a complete response (CR) or a confirmed complete remission with incomplete recovery of neutrophils or platelets (confirmed CRi). Per Cheson Criteria: Confirmed complete remission (CRi) is defined as a disappearance of blasts in the peripheral blood; a decrease in bone marrow blasts to <5% total bone marrow nucleated cells demonstrated in bone marrow aspirate; absence of Auer rods; no persistent extramedullary leukaemia. Complete response (CR) is defined as all requirements to meet CRi and in addition: recovery of neutrophils to =1.0 x 109/L and platelets to =100 x 109/L; transfusion-independence.
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Timepoint [1]
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IWG Cheson criteria every 28 days from randomization for study duration (24 months, between 2009 - 2011)
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Secondary outcome [1]
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Duration of Response (DoR): Stage I and Transition Phase
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Assessment method [1]
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DoR was defined for the median of days which showed a confirmed CRi or CR, as the time from first documented evidence of CRi or CR until the first documented sign of disease progression or death. Duration of Response was measured from the Response Start date until evidence of patient relapse or death. Stage I : 45 patients randomized in a 2:1 ratio to AZD1152 or LDAC. Transition phase: enrollment of up to 30 additional patients randomized as per stage I.
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Timepoint [1]
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DoR was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)
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Secondary outcome [2]
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Disease Free Survival (DFS)
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Assessment method [2]
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Disease-free Survival is defined as the time from randomisation to relapse or death from any cause.
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Timepoint [2]
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DFS was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)
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Secondary outcome [3]
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Time To Complete Response (TTCR)
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Assessment method [3]
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TTCR is measured as time from randomization to either a complete response (CR) or a confirmed complete remission with incomplete recovery of neutrophils or platelets (confirmed CRi)
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Timepoint [3]
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Response was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)
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Secondary outcome [4]
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Overall Survival (OS)
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Assessment method [4]
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Overall Survival is defined as the median time from randomisation to death from any cause. Patients who were not known to have died at the time of the analysis were censored at the date they were last known to be alive.
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Timepoint [4]
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Assessed from randomisation until the date of death from any cause, assessed up to 24 months
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Secondary outcome [5]
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Percent of Patients With Worsened Trial Outcome Index (TOI)
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Assessment method [5]
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TOI is derived from the sum of the Functional Well Being (FWB), Physical Well Being (PWB) and additional subscales of the FACT-Leu. The TOI subscale consists of 31 items with TOI scores ranging from 0 to 124. The TOI is described as a summary measure of HRQoL. Higher scores indicate better HRQoL. Negative changes from baseline indicate a worsening of HRQoL while positive changes indicate an improvement in HRQoL. A response of "Worsened" was a change from baseline in score of less than or equal to -9.
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Timepoint [5]
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TOI was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)
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Secondary outcome [6]
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Percent of Patients With Worsened Functional Assessment of Cancer Therapy - Leukaemia (FACT-Leu) Score.
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Assessment method [6]
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The total FACT-Leu score consists of 44 items with total scores ranging from 0 to 176. Higher scores indicate better HRQoL. Negative changes from baseline indicate a worsening of HRQoL while positive changes indicate an improvement in HRQoL. A response of "Worsened" was a change from baseline in score of less than or equal to -11.
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Timepoint [6]
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FACT-Leu was measured every 28 days from randomization for study duration (24 months, between 2009 - 2011)
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Eligibility
Key inclusion criteria
- Provision of written informed consent
- Newly diagnosed male or female patients aged 60 and over
- De Novo or Secondary AML
- Not eligible for intensive induction with anthracycline-based combination chemotherapy
as a result of at least one of the following:Age =75 years; Adverse cytogenetics,
e.g., as defined by the MRC Prognostic Groupings; WHO performance status >2; Organ
dysfunction arising from significant co-morbidities not directly linked to leukaemia
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Minimum age
60
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participation in another clinical study in which an investigational product was
received within 14 days before the first dose in this study, or at any time if the
patient has not recovered from side-effects associated with that investigational
product
- Administration of LDAC is clinically contraindicated
- Patients with AML of FAB M3 classification Acute Promyelocytic Leukaemia (APL)
- Patients with blast crisis of chronic myeloid leukaemia
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2/Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2011
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Sample size
Target
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Accrual to date
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Final
74
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Research Site - Westmead
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Recruitment hospital [2]
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Research Site - Herston
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Recruitment hospital [3]
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Research Site - Melbourne
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Recruitment hospital [4]
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Research Site - Parkville
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Recruitment postcode(s) [1]
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- Westmead
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Recruitment postcode(s) [2]
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- Herston
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Recruitment postcode(s) [3]
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- Melbourne
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Recruitment postcode(s) [4]
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- Parkville
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Recruitment outside Australia
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United States of America
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State/province [1]
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Georgia
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United States of America
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Illinois
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New York
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United States of America
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Ohio
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United States of America
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Oregon
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United States of America
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South Carolina
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United States of America
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Tennessee
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United States of America
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Texas
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France
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Angers Cedex 01
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France
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Clermont-ferrand
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France
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Grenoble Cedex 09
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France
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Lyon Cedex 03
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France
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Marseille Cedex 09
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France
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Nantes
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Germany
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Duisburg
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Germany
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Erlangen
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Germany
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Frankfurt
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Germany
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Munster
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Germany
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Villingen-schwenningen
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Italy
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BO
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Italy
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GE
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Italy
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TO
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Italy
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Italy
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Roma
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Aichi
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Fukui
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Japan
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Gunma
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Japan
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Kanagawa
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Japan
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Tokyo
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Japan
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Fukuoka
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Romania
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Brasov
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Romania
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TG Mures
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Spain
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Asturias
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Spain
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Cataluna
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Spain
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Comunidad DE Madrid
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Comunidad Valenciana
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Spain
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Madrid
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United Kingdom
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Brighton
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AstraZeneca
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is 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
AML patients.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00952588
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Paul Stockman
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Address
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AstraZeneca
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00952588
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