A Phase 1 Study of AMG 330 in Subjects With Myeloid Malignancies
NCT ID: NCT02520427
Last Updated: 2024-07-31
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE1
95 participants
INTERVENTIONAL
2015-08-31
2022-01-09
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
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Group 1: Relapsed/Refractory Acute Myeloid Leukemia (R/R AML)
AMG 330
0.5 µg/day - 1.6 mg/day cIV infusion administered in cycles from 14 to 28 days.
Group 2: Minimal Residual Disease Positive (MRD+) AML
AMG 330
0.5 µg/day - 1.6 mg/day cIV infusion administered in cycles from 14 to 28 days.
Group 3: Myelodysplastic syndrome (MDS)
AMG 330
0.5 µg/day - 1.6 mg/day cIV infusion administered in cycles from 14 to 28 days.
Group 4: R/R AML with alternative pretreatment
AMG 330
0.5 µg/day - 1.6 mg/day cIV infusion administered in cycles from 14 to 28 days.
Group 5: R/R AML with alternative dose schedule
AMG 330
0.5 µg/day - 1.6 mg/day cIV infusion administered in cycles from 14 to 28 days.
Interventions
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AMG 330
0.5 µg/day - 1.6 mg/day cIV infusion administered in cycles from 14 to 28 days.
Eligibility Criteria
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Inclusion Criteria
* 18 years or older
* Relapsed/refractory AML: AML as defined by the WHO Classification persisting or recurring following one or more treatment courses except promyelocytic leukemia (APML)
Exclusion Criteria
* Known hypersensitivity to immunoglobulins or to any other component of the IP formulation (eg, sucrose, captisol, potassium, polysorbate 80, citrate, lysine)
* Prior malignancy (other than in situ cancer) unless treated with curative intent and without evidence of disease for \> 1 years before screening
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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University of Alabama at Birmingham
Birmingham, Alabama, United States
Research Site
Duarte, California, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Universitätsklinikum Schleswig-Holstein
Kiel, , Germany
Klinikum der Universität München Campus Grosshadern
München, , Germany
Universitatsklinikum Ulm
Ulm, , Germany
Research Site
Amsterdam, , Netherlands
Erasmus Medisch Centrum
Rotterdam, , Netherlands
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2014-004462-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
20120252
Identifier Type: -
Identifier Source: org_study_id
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