COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

A Phase 1 Study of AMG 330 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02520427
Recruitment Status : Recruiting
First Posted : August 11, 2015
Last Update Posted : November 25, 2019
Information provided by (Responsible Party):

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 relapsed/refractory Acute Myeloid Leukemia, 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 Drug: AMG 330 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group 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 Relapsed/Refractory Acute Myeloid Leukemia
Actual Study Start Date : August 31, 2015
Estimated Primary Completion Date : May 16, 2021
Estimated Study Completion Date : May 16, 2021

Arm Intervention/treatment
Experimental: AMG 330
Comparison of different dosages of drug
Drug: AMG 330
0.5-960 µg/day cIV infusion in cycles from 14 to 28 days

Primary Outcome Measures :
  1. Subject incidence of adverse events 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 [ Time Frame: 36 months ]
    Response is defined as CR, CRi, morphologic leukemia-free state [per modified IWG criteria] or CRh*

  3. Efficacy parameter: duration of response [ Time Frame: 36 months ]
  4. Efficacy parameter: time to progression [ Time Frame: 36 months ]
  5. Efficacy parameter: time to response [ Time Frame: 36 months ]
  6. Pharmacokinetic parameter: Half-life of AMG330 [ Time Frame: 32 months ]
  7. Pharmacokinetic parameter: Steady state concentration of AMG330 [ Time Frame: 32 months ]
  8. Pharmacokinetic parameter: Volume of distribution of AMG330 [ Time Frame: 32 months ]
  9. Pharmacokinetic parameter: Clearance of AMG330 [ Time Frame: 32 months ]

Information from the National Library of Medicine

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.

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

Inclusion criteria:

  • Informed consent provided
  • 18 years or older
  • AML as defined by the WHO Classification persisting or recurring following one or more treatment courses except promyelocytic leukemia (APML). For Germany, additional requirements are outlined in a country specific protocol supplement.
  • More than 5% blasts in bone marrow
  • ECOG Performance Status of ≤ 2
  • Adequate renal and hepatic function

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
  • Prior malignancy (other than in situ cancer) unless treated with curative intent and without evidence of disease for > 2 years before screening
  • Autologous HSCT within six weeks prior to start of AMG 330 treatment
  • Allogeneic HSCT within three months prior to start of AMG 330 treatment
  • History or evidence of cardiovascular risk
  • History of arterial thrombosis (eg, stroke or transient ischemic attack) in the past 3 months Infection requiring intravenous antibiotics within 1 week of study enrollment (day 1)
  • Known positiv test for HIV
  • Positive for Hepatitis B
  • Positive for Hepatitis C or chronic Hepatitis C
  • Unresolved toxicities from prior antitumor therapy, defined as not having resolved to CTCAE, version 4.0 grade 1
  • Antitumor therapy (chemotherapy, antibody therapy, molecular-targeted therapy, retinoid therapy, or investigational agent) within 14 days or 5 half-lives of day 1 (whichever is shorter). Exception: hydroxyurea to control peripheral blood leukemic cell counts is allowed until start of IP treatment.
  • Treatment with systemic immune modulators 2 weeks before enrollment (day 1)
  • All herbal medicines (eg, St. John's wort), vitamins, and supplements consumed by the subject within the 30 days prior to receiving the first dose of AMG 330 will be reviewed by the investigator and the Amgen medical monitor
  • Prior treatment with a chimeric antigen receptor T cell (CAR-T) infusion for the treatment of AML (CD33 or other target)
  • Major surgery within 28 days of study day 1 with the exception of biopsy and long line insertion
  • White blood cells (WBC) > 15,000 cells/mcL at screening
  • History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
  • Men and women of reproductive potential who are unwilling to practice a highly effective method(s) of birth control while on study through 1 week (women) or 12 weeks (men)
  • Women who are lactating/breastfeeding or who plan to breastfeed while on sudy through 1 week after receiving the last dose of study drug
  • Women with a positive pregnancy test
  • Women planning to become pregnant while on study through 1 week after receiving the last dose of study drug
  • Subjects likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge

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 identifier (NCT number): NCT02520427

Layout table for location contacts
Contact: Amgen Call Center 866-572-6436

Layout table for location information
United States, California
Research Site Recruiting
Duarte, California, United States, 91010
United States, Texas
Research Site Recruiting
Houston, Texas, United States, 77030
United States, Washington
Research Site Recruiting
Seattle, Washington, United States, 98109
Research Site Recruiting
München, Germany, 81377
Research Site Recruiting
Ulm, Germany, 89081
Research Site Recruiting
Amsterdam, Netherlands, 1007 MB
Research Site Recruiting
Rotterdam, Netherlands, 3015 CE
Sponsors and Collaborators
Layout table for investigator information
Study Director: MD Amgen
Additional Information:
Layout table for additonal information
Responsible Party: Amgen Identifier: NCT02520427    
Other Study ID Numbers: 20120252
2014-004462-20 ( EudraCT Number )
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019
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 link below.
Keywords provided by Amgen:
Phase 1
Clinical Trial
Relapsed/Refractory AML
Additional relevant MeSH terms:
Layout table for MeSH terms
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Leukemia, Myeloid