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

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. Identifier: NCT00530699
Recruitment Status : Completed
First Posted : September 17, 2007
Last Update Posted : September 11, 2009
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Acute Myeloid Leukaemia Drug: AZD1152 Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
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.
Study Start Date : November 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Intervention Details:
  • Drug: AZD1152

Primary Outcome Measures :
  1. 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 :
  1. To examine the pharmacokinetics of AZD1152 [ Time Frame: assessed after dose administration ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
Responsible Party: AstraZeneca, Japan Pharmaceuticals Identifier: NCT00530699     History of Changes
Other Study ID Numbers: D1531C00008
First Posted: September 17, 2007    Key Record Dates
Last Update Posted: September 11, 2009
Last Verified: September 2009

Keywords provided by AstraZeneca:
Acute Myeloid Leukaemia
Phase 1

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type