- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00530699
Safety, Tolerability and PK of AZD1152 in Patients With Relapsed Acute Myeloid Leukaemia (AML)
September 10, 2009 updated by: AstraZeneca
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
30
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fukuoka, Japan
- Research Site
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Aichi
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Nagoya, Aichi, Japan
- Research Site
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Fukui
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Yoshida-gun, Fukui, Japan
- Research Site
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Gunma
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Maebashi-city, Gunma, Japan
- Research Site
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Kanagawa
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Isehara, Kanagawa, Japan
- Research Site
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Yokohama, Kanagawa, Japan
- Research Site
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Tokyo
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Chuo, Tokyo, Japan
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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assessed at each visit
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To examine the pharmacokinetics of AZD1152
Time Frame: assessed after dose administration
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assessed after dose administration
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Paul Stockman, AstraZeneca
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
September 13, 2007
First Submitted That Met QC Criteria
September 14, 2007
First Posted (Estimate)
September 17, 2007
Study Record Updates
Last Update Posted (Estimate)
September 11, 2009
Last Update Submitted That Met QC Criteria
September 10, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D1531C00008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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