Back to resultsSafety, Tolerability and PK of AZD1152 in Patients With Relapsed Acute Myeloid Leukaemia (AML)
Primary Purpose
Acute Myeloid Leukaemia
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
AZD1152
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukaemia focused on measuring Acute Myeloid Leukaemia, Phase 1, AZD1152
Eligibility 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
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Outcomes
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
Secondary Outcome Measures
To examine the pharmacokinetics of AZD1152
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00530699
Brief Title
Safety, Tolerability and PK of AZD1152 in Patients With Relapsed Acute Myeloid Leukaemia (AML)
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 Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukaemia
Keywords
Acute Myeloid Leukaemia, Phase 1, AZD1152
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AZD1152
Intervention Description
intravenous
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To examine the pharmacokinetics of AZD1152
Time Frame
assessed after dose administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Stockman
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Nagoya
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Yoshida-gun
State/Province
Fukui
Country
Japan
Facility Name
Research Site
City
Maebashi-city
State/Province
Gunma
Country
Japan
Facility Name
Research Site
City
Isehara
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Chuo
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Fukuoka
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Safety, Tolerability and PK of AZD1152 in Patients With Relapsed Acute Myeloid Leukaemia (AML)
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