Study summary

The objective of this study was to assess the safety and tolerability, including the maximum tolerated dose, of gilteritinib in participants with relapsed or treatment-refractory acute myeloid leukemia (AML). This study also determined the pharmacokinetic (PK) parameters of gilteritinib.

Additional Study Details

Phase
1/2
Product
  • Gilteritinib
  • Voriconazole
  • Midazolam
  • Cephalexin
  • Type
    Interventional
    Masking
    None (Open Label)
    Enrollment number
    265
    Show Additional Study Details

    Study documents

    Scientific Results Summary
    Available Language(s): English
    Plain Language Summary
    Available Language(s): English
    Protocol
    Available Language(s): English
    Statistical Analysis Plan (SAP)
    Available Language(s): English

    Get more information

    Would you like more information about clinical trial sites that are recruiting participants for Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients with Relapsed or Refractory Acute Myeloid Leukemia? Contact us by filling out your information to the right and we’ll respond to you.

    • A patient
    • A caregiver
    • A parent
    • A healthcare provider
    • A patient advocate
    • Algeria
    • Argentina
    • Armenia
    • Australia
    • Austria
    • Belarus
    • Belgium
    • Bosnia And Herzegovina
    • Brazil
    • Bulgaria
    • Canada
    • Chile
    • China
    • Colombia
    • Croatia
    • Czech Republic
    • Denmark
    • Dominican Republic
    • Egypt
    • Estonia
    • Finland
    • Former Serbia and Montenegro
    • France
    • Georgia
    • Germany
    • Greece
    • Guatemala
    • Hong Kong
    • Hungary
    • Iceland
    • India
    • Indonesia
    • Ireland
    • Israel
    • Italy
    • Japan
    • Jordan
    • Kazakhstan
    • Latvia
    • Lebanon
    • Lithuania
    • Macedonia
    • Malaysia
    • Mexico
    • Montenegro
    • Morocco
    • Netherlands
    • New Zealand
    • Norway
    • Panama
    • Peru
    • Philippines
    • Poland
    • Portugal
    • Puerto Rico
    • Republic of Korea
    • Republic of Moldova
    • Romania
    • Russian Federation
    • Saudi Arabia
    • Serbia
    • Singapore
    • Slovakia
    • Slovenia
    • South Africa
    • Spain
    • Sweden
    • Switzerland
    • Taiwan, Province of China
    • Thailand
    • Turkey
    • Ukraine
    • United Kingdom
    • United States
    • Vietnam

    By clicking ["Continue/Submit"], you agree that Astellas may contact you by email with information to help you connect with clinical trial sites. While we can connect you to clinical trial sites, we cannot answer questions about any investigational therapy through email. Your consent to receiving emails is not a requirement to participate in a clinical trial or study. For more information, including how to unsubscribe at any time, see our Privacy Notice & Cookies Policy.

      Locations

      Contact Us
      Contact Us
      Completed
      Site US10007
      Nashville, TN, United States, 37232
      Completed
      Site US10012
      Baltimore, MD, United States, 21201
      Completed
      Site US10009
      New York, NY, United States, 10022
      Completed
      Site US10026
      Fairfax, VA, United States, 22031
      Completed
      Site DE49002
      Berlin, Berlin, Germany, 12203
      Completed
      Site IT39001
      Bologna, Italy, 40138
      Withdrawn
      Site US10016
      Stanford, CA, United States, 94305
      Completed
      Site US10005
      San Francisco, CA, United States, 94143
      Withdrawn
      Site FR33002
      Pessac, France, 33604
      Completed
      Site US10002
      Houston, TX, United States, 77030
      Completed
      Site US10023
      Scottsdale, AZ, United States, 85259
      Withdrawn
      Site DE49001
      Ulm, Germany, 89081
      Withdrawn
      Site DE49005
      Marburg, Germany, 35043
      Completed
      Site US10008
      Los Angeles, CA, United States, 90095-1678
      Completed
      Site US10004
      Philadelphia, PA, United States, 19104
      Withdrawn
      Site FR33001
      Angers, France, 49033
      Completed
      Site US10001
      Chicago, IL, United States, 60611
      Completed
      Site US10017
      Charleston, SC, United States, 29425-8900
      Withdrawn
      Site DE49003
      Magdeburg, Germany, 39120
      Completed
      Site US10014
      Cleveland, OH, United States, 44195
      Withdrawn
      Site FR33003
      Grenoble Cedex, France, 38043
      Completed
      Site US10018
      Hershey, PA, United States, 17033
      Withdrawn
      Site US10024
      Jacksonville, FL, United States, 32224
      Completed
      Site US10021
      Birmingham, AL, United States, 35294
      Completed
      Site US10019
      New York, NY, United States, 10065
      Completed
      Site US10022
      Duarte, CA, United States, 91010
      Completed
      Site US10010
      Buffalo, NY, United States, 14263
      Completed
      Site US10003
      Baltimore, MD, United States, 21287
      Completed
      Site US10013
      New York, NY, United States, 10032
      Completed
      Site US10015
      Chicago, IL, United States, 60637
      Completed
      Site US10011
      Rochester, MN, United States, 55905
      Completed
      Site DE49004
      Dresden, Germany, 01307
      Completed
      Site US10020
      Hackensack, NJ, United States, 07601
      Completed
      Site US10006
      Minneapolis, MN, United States, 55455

      Frequently Asked Questions

      Are clinical trials only for people with advanced cancer?

      While some clinical trials may focus on more advanced cancers, many trials are open to patients at various stages of their cancer. Each study has rules about who can take part. For example, only patients in a certain age group or those who have a certain type of tumor may be able to join.

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      In cancer clinical trials, a placebo is only used if there is no other treatment for that type of cancer. This helps compare an investigational treatment to the placebo. Placebos are rarely used in cancer trials because the best available treatment, called the “standard of care”, is usually given instead.

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