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A Phase 1 Study of AMG 330 in Subjects With Myeloid Malignancies

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ClinicalTrials.gov Identifier: NCT02520427
Recruitment Status : Recruiting
First Posted : August 11, 2015
Last Update Posted : July 1, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
The purpose of this First-in-Human Phase 1 study is to determine if AMG 330 given as a continuous IV infusion is safe and tolerable in adult subjects that have myeloid malignancies, and to determine the maximum tolerated dose and/or a biologically active dose. The study will be conducted in multiple sites and test increasing doses of AMG 330. The safety of subjects will be monitored by intensive assessment of vital signs, electrocardiograms, physical examinations, and laboratory tests.

Condition or disease Intervention/treatment Phase
Relapsed/Refractory AML Minimal Residual Disease Positive AML Myelodysplastic Syndrome Drug: AMG 330 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 256 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 First-in-human Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 330 Administered as Continuous Intravenous Infusion in Subjects With Myeloid Malignancies
Actual Study Start Date : August 31, 2015
Estimated Primary Completion Date : August 15, 2022
Estimated Study Completion Date : August 15, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1: Relapsed/Refractory Acute Myeloid Leukemia (R/R AML) Drug: AMG 330
0.5 µg/day - 1.6 mg/day cIV infusion administered in cycles from 14 to 28 days.

Experimental: Group 2: Minimal Residual Disease Positive (MRD+) AML Drug: AMG 330
0.5 µg/day - 1.6 mg/day cIV infusion administered in cycles from 14 to 28 days.

Experimental: Group 3: Myelodysplastic syndrome (MDS) Drug: AMG 330
0.5 µg/day - 1.6 mg/day cIV infusion administered in cycles from 14 to 28 days.

Experimental: Group 4: R/R AML with alternative pretreatment Drug: AMG 330
0.5 µg/day - 1.6 mg/day cIV infusion administered in cycles from 14 to 28 days.

Experimental: Group 5: R/R AML with alternative dose schedule Drug: AMG 330
0.5 µg/day - 1.6 mg/day cIV infusion administered in cycles from 14 to 28 days.




Primary Outcome Measures :
  1. Subject incidence of adverse events (AEs) as a measure of safety [ Time Frame: 36 months ]
  2. Subject incidence of dose-limiting toxicities (DLTs) as a measure of safety [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. Incidence of anti-AMG 330 antibody formation [ Time Frame: 36 months ]
  2. Efficacy parameter: Response rate in subjects with relapsed/refractory acute myeloid leukemia [ Time Frame: 36 months ]
  3. Efficacy parameter: Response rate in subjects with myelodysplastic syndrome [ Time Frame: 36 months ]
  4. Efficacy parameter: Response rate in subjects with minimal residual disease (MRD) positive acute myeloid leukemia [ Time Frame: 36 months ]
  5. Efficacy parameter: Duration of response [ Time Frame: 36 months ]
  6. Efficacy parameter: Time to progression [ Time Frame: 36 months ]
  7. Efficacy parameter: Time to response [ Time Frame: 36 months ]
  8. Pharmacokinetic parameter: Half-life of AMG 330 [ Time Frame: 32 months ]
  9. Pharmacokinetic parameter: Steady state concentration of AMG 330 [ Time Frame: 32 months ]
  10. Pharmacokinetic parameter: Volume of distribution of AMG 330 [ Time Frame: 32 months ]
  11. Pharmacokinetic parameter: Clearance of AMG 330 [ Time Frame: 32 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Informed consent provided
  • 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:

  • Active extramedullary AML in testes or central nervous system (CNS)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02520427


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294-3300
United States, California
Research Site Recruiting
Duarte, California, United States, 91010
United States, North Carolina
Wake Forest Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Germany
Universitätsklinikum Schleswig-Holstein Recruiting
Kiel, Germany, 24105
Klinikum der Universität München Campus Großhadern Recruiting
München, Germany, 81377
Universitatsklinikum Ulm Recruiting
Ulm, Germany, 89081
Netherlands
Research Site Recruiting
Amsterdam, Netherlands, 1007 MB
Erasmus Medisch Centrum Recruiting
Rotterdam, Netherlands, 3015 CE
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02520427    
Other Study ID Numbers: 20120252
2014-004462-20 ( EudraCT Number )
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: July 1, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
URL: https://www.amgen.com/datasharing
Keywords provided by Amgen:
Amgen
Phase 1
Clinical Trial
Oncology/Hematology
Relapsed/Refractory AML
Immunotherapy
Additional relevant MeSH terms:
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Neoplasm, Residual
Myelodysplastic Syndromes
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Neoplastic Processes
Pathologic Processes