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Safety, Tolerability and PK of AZD1152 in Patients With Relapsed Acute Myeloid Leukaemia (AML)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00530699
First Posted: September 17, 2007
Last Update Posted: September 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
September 13, 2007
September 17, 2007
September 11, 2009
November 2007
August 2009   (Final data collection date for primary outcome measure)
To assess the safety and tolerability of AZD1152 in patients with AML by assessment of AEs, vital signs, ECG parameters, clinical chemistry, haematology (including clotting parameters) and urinalysis [ Time Frame: assessed at each visit ]
To assess the safety and tolerability of AZD1152 in patients with AML by assessment of AEs, vital signs, ECG parameters, clinical chemistry, haematology (including clotting parameters) and urinalysis
Complete list of historical versions of study NCT00530699 on ClinicalTrials.gov Archive Site
To examine the pharmacokinetics of AZD1152 [ Time Frame: assessed after dose administration ]
To examine the pharmacokinetics of AZD1152
Not Provided
Not Provided
 
Safety, Tolerability and PK of AZD1152 in Patients With Relapsed Acute Myeloid Leukaemia (AML)
A Phase I, Open Label, Multi-centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD1152 in Japanese Patients With Acute Myeloid Leukaemia.
The purpose of this study is to assess safety and tolerability of multiple ascending doses of AZD1152 and to assess effect of AZD1152 on the rate of complete remission in patients with relapsed acute myeloid leukaemia who are not considered to be suitable for standard chemotherapy.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Myeloid Leukaemia
Drug: AZD1152
intravenous
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2009
August 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with relapsed or refractory AML for which no standard therapies are anticipated to result in durable remission
  • Newly diagnosed Acute Myeloid Leukemia who are not considered suitable for other treatments.

Exclusion Criteria:

  • Administration of anticancer agents (other than hydroxyurea) within 2 weeks prior to first dose of study drug, and administration of hydroxyurea within 24 hours prior to first dose of study drug
  • Participation in any other trial with an investigational product within the previous 30 days.
  • Uncontrolled intercurrent illness including, but not limited to, active infection, symptomatic congestive heart failure, cardiac arrhythmia or psychiatric illness/social situations
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00530699
D1531C00008
Yes
Not Provided
Not Provided
AstraZeneca, Japan Pharmaceuticals
AstraZeneca
Not Provided
Study Director: Paul Stockman AstraZeneca
AstraZeneca
September 2009

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