Back to resultsSafety, Tolerability, PK and Efficacy of AZD1152 in Patients With Relapsed Acute Myeloid Leukemia
Primary Purpose
Myeloid Leukemia
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
AZD1152
Sponsored by
About this trial
This is an interventional treatment trial for Myeloid Leukemia focused on measuring AML, phase I/II, AZD1152, Acute Myeloid Leukaemia
Eligibility Criteria
Inclusion Criteria:
- Relapsed or refractory AML for which no standard therapies are anticipated to result in durable remission
- Newly diagnosed AML who are not considered suitable for other treatments.
Exclusion Criteria:
- Previous myeloablative therapy allogeneic bone marrow or stem cell transplantation, radiotherapy or chemotherapy within 4 weeks of first dose.
- Participation in any other trial with an investigational product within the previous 30 days
- Other active malignancy.
Sites / Locations
- Research Site
- Research Site
- Research Site
- 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 multiple ascending doses AZD1152 in patients with AML by assessment of AEs, vital signs, ECG parameters, clinical chemistry, haematology (including clotting parameters) and urinalysis.
To determine the rate of complete remission from baseline changes in bone marrow and blood myeloblast counts and recovery of normal haemopoiesis
Secondary Outcome Measures
To determine the pharmacokinetics, pharmacodynamics, efficacy, safety and tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00497991
Brief Title
Safety, Tolerability, PK and Efficacy of AZD1152 in Patients With Relapsed Acute Myeloid Leukemia
Official Title
A Phase I/II, Open Label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of AZD1152 in Patients With Acute Myeloid Leukaemia.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloid Leukemia
Keywords
AML, phase I/II, AZD1152, Acute Myeloid Leukaemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AZD1152
Primary Outcome Measure Information:
Title
To assess the safety and tolerability of multiple ascending doses 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
Title
To determine the rate of complete remission from baseline changes in bone marrow and blood myeloblast counts and recovery of normal haemopoiesis
Time Frame
Change from baseline
Secondary Outcome Measure Information:
Title
To determine the pharmacokinetics, pharmacodynamics, efficacy, safety and tolerability
Time Frame
Assessed at each visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Relapsed or refractory AML for which no standard therapies are anticipated to result in durable remission
Newly diagnosed AML who are not considered suitable for other treatments.
Exclusion Criteria:
Previous myeloablative therapy allogeneic bone marrow or stem cell transplantation, radiotherapy or chemotherapy within 4 weeks of first dose.
Participation in any other trial with an investigational product within the previous 30 days
Other active malignancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Stockman, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Bob Lowenberg, MD, PhD
Organizational Affiliation
Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
New York
State/Province
New York
Country
United States
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Angers Cedex
Country
France
Facility Name
Research Site
City
Grenoble Cedex
Country
France
Facility Name
Research Site
City
Le Chesnay Cedex
Country
France
Facility Name
Research Site
City
Bologna
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy
Facility Name
Research Site
City
Amsterdam
Country
Netherlands
Facility Name
Research Site
City
Nijmegen
Country
Netherlands
Facility Name
Research Site
City
Rotterdam
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
21976672
Citation
Lowenberg B, Muus P, Ossenkoppele G, Rousselot P, Cahn JY, Ifrah N, Martinelli G, Amadori S, Berman E, Sonneveld P, Jongen-Lavrencic M, Rigaudeau S, Stockman P, Goudie A, Faderl S, Jabbour E, Kantarjian H. Phase 1/2 study to assess the safety, efficacy, and pharmacokinetics of barasertib (AZD1152) in patients with advanced acute myeloid leukemia. Blood. 2011 Dec 1;118(23):6030-6. doi: 10.1182/blood-2011-07-366930. Epub 2011 Oct 5.
Results Reference
derived
Learn more about this trial
Safety, Tolerability, PK and Efficacy of AZD1152 in Patients With Relapsed Acute Myeloid Leukemia
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