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Study of AMG 673 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03224819
Recruitment Status : Active, not recruiting
First Posted : July 21, 2017
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
This is a first-in-human, open-label, phase 1, sequential dose escalation study. AMG 673 will be evaluated as a short term intravenous (IV) infusion in adult subjects with relapsed/refractory AML. The study will be conducted at approximately 7 sites in the United States, Australia and Germany.

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Drug: AMG 673 Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 95 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Bayesian Model
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 673 Administered as Short Term Intravenous Infusions in Subjects With Relapsed/Refractory Acute Myeloid Leukemia
Actual Study Start Date : September 7, 2017
Estimated Primary Completion Date : December 20, 2021
Estimated Study Completion Date : December 20, 2021


Arm Intervention/treatment
Experimental: Exploration Phase
Dose finding phase of the study
Drug: AMG 673
Open label.

Experimental: Expansion Phase
Maximum Tolerated Dose identified by Exploration Phase administered to subjects
Drug: AMG 673
Open label.




Primary Outcome Measures :
  1. Subject incidence and grade of adverse events [ Time Frame: 18 months ]
  2. Dose limiting toxicities (DLTs) [ Time Frame: 18 Months ]

Secondary Outcome Measures :
  1. Pharmacokinetic parameter - half-life [ Time Frame: 18 months ]
  2. Pharmacokinetic parameter - steady state [ Time Frame: 18 months ]
  3. Pharmacokinetic parameter - Concentration [ Time Frame: 18 months ]
  4. Pharmacokinetic parameter - Volume of distribution [ Time Frame: 18 months ]
  5. Pharmacokinetic parameter - Clearance of AMG 673 [ Time Frame: 18 months ]
  6. Efficacy parameters - response rate [ Time Frame: 18 months ]
  7. Efficacy parameters - duration of response [ Time Frame: 18 months ]
  8. Efficacy parameters - time to progression [ Time Frame: 18 months ]
  9. Efficacy parameters - time to response [ Time Frame: 18 months ]


Information from the National Library of Medicine

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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

  • Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
  • Subjects ≥ 18 years of age at the time of signing consent.
  • AML as defined by the WHO Classification (Appendix D) persisting or recurring following 1 or more treatment courses except promyelocytic leukemia (APML).

More than 5% myeloblasts in bone marrow.

-Eastern Cooperative Oncology Group (ECOG, Appendix F) Performance Status of ≤ 2.

Exclusion Criteria

  • Known hypersensitivity to immunoglobulins.
  • Autologous HSCT within 6 weeks prior to start of AMG 673 treatment.
  • Allogeneic HSCT within 3 months prior to start of AMG 673 treatment.
  • Non-manageable graft versus host disease.
  • Known positive test for human immunodeficiency virus (HIV).
  • Males and females of reproductive potential who are unwilling to practice a highly effective method(s) of birth control while on study through 15 weeks after receiving the last dose of study drug. Acceptable methods of highly effective birth control include sexual abstinence (males, females); vasectomy; bilateral tubal ligation/occlusion; or a condom with spermicide (men) in combination with hormonal birth control or intrauterine device (IUD) (women). Males who are unwilling to abstain from sperm donation while on study through 5 half-lives after receiving the (last [multiple-dose studies]) dose of study drug.
  • Females who are lactating/breastfeeding or who plan to breastfeed while on study through 15 weeks after receiving the last dose of study drug.
  • Females with a positive pregnancy test
  • Females planning to become pregnant while on study through 15 weeks after receiving the last dose of study drug.

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): NCT03224819


Locations
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United States, Alabama
Research Site
Birmingham, Alabama, United States, 35249
United States, California
Research Site
Duarte, California, United States, 91010
United States, Texas
Research Site
Houston, Texas, United States, 77030
United States, Washington
Research Site
Seattle, Washington, United States, 98195
Australia, Victoria
Research Site
Melbourne, Victoria, Australia, 3004
Research Site
Parkville, Victoria, Australia, 3050
Germany
Research Site
München, Germany, 81377
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: NCT03224819    
Other Study ID Numbers: 20160377
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 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 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. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. 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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms