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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00530699
First received: September 13, 2007
Last updated: September 10, 2009
Last verified: September 2009
History of Changes
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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
    intravenous
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00530699

Locations
Japan
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
AstraZeneca
Investigators
Study Director: Paul Stockman AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca, Japan Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00530699     History of Changes
Other Study ID Numbers: D1531C00008
Study First Received: September 13, 2007
Last Updated: September 10, 2009
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by AstraZeneca:
Acute Myeloid Leukaemia
Phase 1
AZD1152

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

ClinicalTrials.gov processed this record on May 21, 2013