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 : Terminated (Priortization of other programs)
First Posted : July 21, 2017
Last Update Posted : March 18, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: AMG 673||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Bayesian Model|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||December 28, 2020|
|Actual Study Completion Date :||December 28, 2020|
Experimental: Exploration Phase
Dose finding phase of the study
Drug: AMG 673
Experimental: Expansion Phase
Maximum Tolerated Dose identified by Exploration Phase administered to subjects
Drug: AMG 673
- Subject incidence and grade of adverse events [ Time Frame: 18 months ]
- Dose limiting toxicities (DLTs) [ Time Frame: 18 Months ]
- Pharmacokinetic parameter - half-life [ Time Frame: 18 months ]
- Pharmacokinetic parameter - steady state [ Time Frame: 18 months ]
- Pharmacokinetic parameter - Concentration [ Time Frame: 18 months ]
- Pharmacokinetic parameter - Volume of distribution [ Time Frame: 18 months ]
- Pharmacokinetic parameter - Clearance of AMG 673 [ Time Frame: 18 months ]
- Efficacy parameters - response rate [ Time Frame: 18 months ]
- Efficacy parameters - duration of response [ Time Frame: 18 months ]
- Efficacy parameters - time to progression [ Time Frame: 18 months ]
- Efficacy parameters - time to response [ Time Frame: 18 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
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
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, California|
|City of Hope National Medical Center|
|Duarte, California, United States, 91010|
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98109|
|The Alfred Hospital|
|Melbourne, Victoria, Australia, 3004|
|The Royal Melbourne Hospital|
|Parkville, Victoria, Australia, 3050|
|Klinikum der Ludwig Maximilians Univeritaet|
|MÃ¼nchen, Germany, 81377|
|Other Study ID Numbers:||
|First Posted:||July 21, 2017 Key Record Dates|
|Last Update Posted:||March 18, 2022|
|Last Verified:||March 2022|
|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|
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.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type