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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 : December 6, 2017
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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 : June 30, 2018
Estimated Study Completion Date : June 30, 2018

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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) and except AML secondary to prior myelodysplastic syndrome. For Germany only: AML as defined by the WHO Classification either persisting/refractory after at least 2 primary induction courses (ie, no response after at least 2 prior chemotherapy cycles) or recurring after having achieved an initial response to chemotherapy except promyelocytic leukemia (APML) and except AML secondary to prior myelodysplastic syndrome.
  • 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
  • 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
  • For subjects in expansion cohort only: Ingestion of any food or drink containing grapefruit or Seville oranges, or St. John´s wort, within 7 days prior to receiving the first dose of AMG 330
  • Prior treatment with a monoclonal antibody or chimeric antigen receptor T cell infusion for the treatment of AML
  • Prior participation in an investigational study within 21 days of study day 1
  • 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

Contact: Amgen Call Center 866-572-6436

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
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen Identifier: NCT02520427     History of Changes
Other Study ID Numbers: 20120252
2014-004462-20 ( EudraCT Number )
First Posted: August 11, 2015    Key Record Dates
Last Update Posted: December 6, 2017
Last Verified: November 2017

Keywords provided by Amgen:
Phase 1
Clinical Trial
Relapsed/Refractory AML

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antibodies, Bispecific
Immunologic Factors
Physiological Effects of Drugs