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.
1 other identifier
interventional
30
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2007
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2007
CompletedFirst Posted
Study publicly available on registry
September 17, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedSeptember 11, 2009
September 1, 2009
1.8 years
September 13, 2007
September 10, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
assessed at each visit
Secondary Outcomes (1)
To examine the pharmacokinetics of AZD1152
assessed after dose administration
Interventions
intravenous
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (7)
Research Site
Nagoya, Aichi-ken, Japan
Research Site
Yoshida-gun, Fukui, Japan
Research Site
Fukuoka, Fukuoka, Japan
Research Site
Maebashi, Gunma, Japan
Research Site
Isehara, Kanagawa, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Chūō, Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paul Stockman
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 13, 2007
First Posted
September 17, 2007
Study Start
November 1, 2007
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
September 11, 2009
Record last verified: 2009-09