Phase I/II, Open-label, Multi-center, Two Part Dose-escalation, Safety, Pharmacokinetics (PK) and Efficacy Study of AZD4877 in Patients With Acute Myelogenous Leukemia (AML)
NCT ID: NCT00486265
Last Updated: 2010-12-21
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
47 participants
INTERVENTIONAL
2007-07-31
2009-07-31
Brief Summary
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For enrollment information see the Central Contact information below
Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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AZD4877
intravenous infusion administered on days 1, 2 and 3
Eligibility Criteria
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Inclusion Criteria
* Part B: AML who have had no more than two prior relapses or failed to achieve remission after at least one induction treatment.
* Patients with prior allogeneic transplants who remain clinically stable for ≥2 weeks or more off immunosuppressive therapy
Exclusion Criteria
* Prior allogeneic transplant requiring immunosuppressive therapy or treating physician does not consider patient to be a candidate for allogeneic transplantation.
* Liver injury
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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Gregory A Curt, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Chicago, Illinois, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Toronto, Ontario, Canada
Countries
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References
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Kantarjian HM, Padmanabhan S, Stock W, Tallman MS, Curt GA, Li J, Osmukhina A, Wu K, Huszar D, Borthukar G, Faderl S, Garcia-Manero G, Kadia T, Sankhala K, Odenike O, Altman JK, Minden M. Phase I/II multicenter study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD4877 in patients with refractory acute myeloid leukemia. Invest New Drugs. 2012 Jun;30(3):1107-15. doi: 10.1007/s10637-011-9660-2. Epub 2011 Apr 15.
Other Identifiers
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D2782C00007
Identifier Type: -
Identifier Source: org_study_id