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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00926731
First received: June 22, 2009
Last updated: June 15, 2011
Last verified: June 2011

June 22, 2009
June 15, 2011
June 2009
August 2010   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00926731 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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)

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myeloid Leukemia
  • Drug: AZD1152
    Variable dose via a 7-day continuous infusion
  • Drug: LDAC (low dose cytosine arabinoside)
    20 mg subcutaneous injection given twice daily
Experimental: 1
AZD1152 variable dose in combination with 20 mg of LDAC. (The LDAC is given twice daily.)
Interventions:
  • Drug: AZD1152
  • Drug: LDAC (low dose cytosine arabinoside)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4
May 2011
August 2010   (final data collection date for primary outcome measure)

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).
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France
 
NCT00926731
D1531C00018
Not Provided
Paul K. Stockman, MBChB, PhD, Medical Science Director (Emerging Products Team II), AstraZeneca Pharmaceuticals
AstraZeneca
Not Provided
Study Director: Paul Stockman AstraZeneca
Principal Investigator: Hagop Kantarjian M. D. Anderson, (University of Texas)
AstraZeneca
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP