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

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: September 13, 2007
Last updated: September 10, 2009
Last verified: September 2009
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.

Condition Intervention Phase
Acute Myeloid Leukaemia Drug: AZD1152 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 Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD1152 in Japanese Patients With Acute Myeloid Leukaemia.

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • To examine the pharmacokinetics of AZD1152 [ Time Frame: assessed after dose administration ]

Estimated Enrollment: 30
Study Start Date: November 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: AZD1152

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  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: NCT00530699

Research Site
Nagoya, Aichi, Japan
Research Site
Yoshida-gun, Fukui, Japan
Research Site
Maebashi-city, Gunma, Japan
Research Site
Isehara, Kanagawa, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Chuo, Tokyo, Japan
Research Site
Fukuoka, Japan
Sponsors and Collaborators
Study Director: Paul Stockman AstraZeneca
  More Information

Additional Information:
Responsible Party: AstraZeneca, Japan Pharmaceuticals Identifier: NCT00530699     History of Changes
Other Study ID Numbers: D1531C00008
Study First Received: September 13, 2007
Last Updated: September 10, 2009

Keywords provided by AstraZeneca:
Acute Myeloid Leukaemia
Phase 1

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms processed this record on September 19, 2017