Study Evaluating Orally Administered AMG 900 in Adult Subjects With Acute Myeloid Leukemia
NCT ID: NCT01380756
Last Updated: 2017-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
35 participants
INTERVENTIONAL
2011-10-04
2014-09-04
Brief Summary
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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
Study Groups
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Arm 1- Dose Escalation
The dose escalation will be conducted in 2 parts. Group 1 will consist of 8 cohorts and Group 2 will consist of 5 cohorts. The dose escalation is aimed at determining the maximum tolerated dose (MTD) of AMG 900.
Arm 1- Dose Escalation
AMG 900 is a small molecule aurora kinase inhibitor. AMG 900 will be administered daily for 4 days every 2 weeks or daily 7 days every 2 weeks (ie.g., 4 consecutive days of dosing followed by 10 consecutive days off treatment).
Arm 2- Dose Expansion
The dose expansion part of the study will begin after completion of the dose escalation phase and will consist of 20 subjects with acute myelogenous leukemia.
Arm 2- Dose Expansion
AMG 900 is a small molecule aurora kinases inhibitor. The dose expansion phase would be conducted to gain further clinical experience with AMG 900 in AML at the optimal dose schedule.
Interventions
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Arm 1- Dose Escalation
AMG 900 is a small molecule aurora kinase inhibitor. AMG 900 will be administered daily for 4 days every 2 weeks or daily 7 days every 2 weeks (ie.g., 4 consecutive days of dosing followed by 10 consecutive days off treatment).
Arm 2- Dose Expansion
AMG 900 is a small molecule aurora kinases inhibitor. The dose expansion phase would be conducted to gain further clinical experience with AMG 900 in AML at the optimal dose schedule.
Eligibility Criteria
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Inclusion Criteria
* Pathologically documented, definitively diagnosed AML that has failed standard treatments or for which no standard therapy is available or the subject refuses standard therapy
* Must consent to undergo bone marrow biopsies per schedule of assessments
Exclusion Criteria
* History of or active central nervous system leukemia
* Prior allogeneic bone marrow transplant
* Subject will not be available for protocol-required study visits or procedures
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Stony Brook, New York, United States
Research Site
Cleveland, Ohio, United States
Research Site
Houston, Texas, United States
Countries
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References
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Kantarjian HM, Schuster MW, Jain N, Advani A, Jabbour E, Gamelin E, Rasmussen E, Juan G, Anderson A, Chow VF, Friberg G, Vogl FD, Sekeres MA. A phase 1 study of AMG 900, an orally administered pan-aurora kinase inhibitor, in adult patients with acute myeloid leukemia. Am J Hematol. 2017 Jul;92(7):660-667. doi: 10.1002/ajh.24736. Epub 2017 Jun 5.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20101351
Identifier Type: -
Identifier Source: org_study_id