NCT00926731

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2009

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

June 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 24, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

June 16, 2011

Status Verified

June 1, 2011

Enrollment Period

1.2 years

First QC Date

June 22, 2009

Last Update Submit

June 15, 2011

Conditions

Acute Myeloid Leukemia

Keywords

Acute Myeloid Leukaemia (AML)

Outcome Measures

Primary Outcomes (1)

  • Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology and Urinalysis

    Information on these will be collected from the time of informed consent is signed, throughout the study.

Secondary Outcomes (1)

  • Assessment of the pharmacokinetics of AZD1152, its active moiety AZD1152 hQPA, and LDAC.

    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.

Study Arms (1)

1

EXPERIMENTAL

AZD1152 variable dose in combination with 20 mg of LDAC. (The LDAC is given twice daily.)

Drug: AZD1152Drug: LDAC (low dose cytosine arabinoside)

Interventions

AZD1152DRUG

Variable dose via a 7-day continuous infusion

1
LDAC (low dose cytosine arabinoside)DRUG

20 mg subcutaneous injection given twice daily

1

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Research Site

Cleveland, Ohio, United States

Location

Research Site

Houston, Texas, United States

Location

Research Site

Le Chesnay, France

Location

Research Site

Villejuif, France

Location

Related Publications (2)

  • Kantarjian 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: 23763917DERIVED

  • Quintas-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: 23071272DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

2-((3-((4-((5-(2-((3-fluorophenyl)amino)-2-oxoethyl)-1H-pyrazol-3-yl)amino)quinazolin-7-yl)oxy)propyl)(ethyl)amino)ethyl dihydrogen phosphateCytarabine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Paul Stockman

    AstraZeneca

    STUDY DIRECTOR

  • Hagop Kantarjian

    M. D. Anderson, (University of Texas)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 22, 2009

First Posted

June 24, 2009

Study Start

June 1, 2009

Primary Completion

August 1, 2010

Study Completion

May 1, 2011

Last Updated

June 16, 2011

Record last verified: 2011-06

Locations

US(2)FR(2)