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
N/A
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 caregiver
  • A healthcare provider
  • A parent
  • A patient
  • 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

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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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