A Phase 1b Study Evaluating AMG 232 Alone and in Combination With Trametinib in Acute Myeloid Leukemia
NCT ID: NCT02016729
Last Updated: 2019-02-27
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
36 participants
INTERVENTIONAL
2014-04-01
2017-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AMG 232
AMG 232 is an anti-cancer agent
AMG 232
Given an an oral tablet in escalating doses.
Trametinib
Trametinib is an oral tablet given in a fixed dose.
AMG 232 & Trametinib
AMG 232 and Trametinib are anti cancer agents
Trametinib
Trametinib is an oral tablet given in a fixed dose.
Interventions
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AMG 232
Given an an oral tablet in escalating doses.
Trametinib
Trametinib is an oral tablet given in a fixed dose.
Eligibility Criteria
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Inclusion Criteria
* Pathologically-documented, definitively-diagnosed AML that is relapsed or refractory to standard treatment, for which no standard therapy is available or the subject refuses standard therapy
* Ability to take oral medications and willing to record daily adherance to investigational product
* Adequate hematological, renal, hepatic, and coagulation laboratory assessments
Exclusion Criteria
* Prior participation in an investigational study (procedure or device) within 21 days of study day 1
* Major surgery within 28 days of study day 1
* Anti-tumor therapy within 14 days of study day 1
18 Years
ALL
No
Sponsors
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Kartos Therapeutics, Inc.
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
Birmingham, Alabama, United States
Research Site
Buffalo, New York, United States
Research Site
Charlotte, North Carolina, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Seattle, Washington, United States
Countries
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References
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Erba HP, Becker PS, Shami PJ, Grunwald MR, Flesher DL, Zhu M, Rasmussen E, Henary HA, Anderson AA, Wang ES. Phase 1b study of the MDM2 inhibitor AMG 232 with or without trametinib in relapsed/refractory acute myeloid leukemia. Blood Adv. 2019 Jul 9;3(13):1939-1949. doi: 10.1182/bloodadvances.2019030916.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20120234
Identifier Type: -
Identifier Source: org_study_id
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