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Study to Assess the Safety and Tolerability of AZD1152 in Combination With Low Dose Cytosine Arabinoside (LDAC)

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: June 22, 2009
Last updated: June 15, 2011
Last verified: June 2011
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.

Condition Intervention Phase
Acute Myeloid Leukemia Drug: AZD1152 Drug: LDAC (low dose cytosine arabinoside) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Safety as measured by Adverse Events, Vital Signs, ECGs, Clinical Chemistry, Haematology and Urinalysis [ Time Frame: Information on these will be collected from the time of informed consent is signed, throughout the study. ]

Secondary Outcome Measures:
  • Assessment of the pharmacokinetics of AZD1152, its active moiety AZD1152 hQPA, and LDAC. [ Time Frame: 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. ]

Enrollment: 4
Study Start Date: June 2009
Study Completion Date: May 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AZD1152 variable dose in combination with 20 mg of LDAC. (The LDAC is given twice daily.)
Drug: AZD1152
Variable dose via a 7-day continuous infusion
Drug: LDAC (low dose cytosine arabinoside)
20 mg subcutaneous injection given twice daily


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00926731

United States, Ohio
Research Site
Cleveland, Ohio, United States
United States, Texas
Research Site
Houston, Texas, United States
Research Site
Le Chesnay Cedex, France
Research Site
Villejuif Cedex, France
Sponsors and Collaborators
Study Director: Paul Stockman AstraZeneca
Principal Investigator: Hagop Kantarjian M. D. Anderson, (University of Texas)
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Paul K. Stockman, MBChB, PhD, Medical Science Director (Emerging Products Team II), AstraZeneca Pharmaceuticals Identifier: NCT00926731     History of Changes
Other Study ID Numbers: D1531C00018
Study First Received: June 22, 2009
Last Updated: June 15, 2011

Keywords provided by AstraZeneca:
Acute Myeloid Leukaemia (AML)

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs processed this record on August 17, 2017