Study summary

The purpose of phase 1 part in this study was to determine the maximum tolerated dose (MTD) and/or recommended expansion dose (RED) of ASP2215 concomitant with cytarabine/idarubicin as induction chemotherapy based on the status of the onset of dose-limiting toxicity (DLT) in newly diagnosed Acute Myeloid Leukemia (AML) subjects. Phase 1 part also evaluated safety and tolerability and characterized the pharmacokinetic (PK) parameters of ASP2215 concomitant with induction and consolidation chemotherapy as well as evaluated the PK parameters of cytarabine concomitant with ASP2215.

The purpose of phase 2 part was to evaluate efficacy of ASP2215 in combination with induction therapy. Phase 2 cohort also evaluated safety and characterized the PK parameters of ASP2215 in combination with induction and consolidation therapy followed by maintenance therapy in newly diagnosed FLT3-mutated AML subjects.

Additional Study Details

Phase
Phase 1/Phase 2
Product
  • Gilteritinib
  • Idarubicin
  • Cytarabine
  • Type
    Interventional
    Masking
    None (Open Label)
    Enrollment number
    97
    Show Additional Study Details

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    Would you like more information about clinical trial sites that are recruiting participants for A Study of ASP2215 in Combination with Induction and Consolidation Chemotherapy in Patients with Newly Diagnosed Acute Myeloid Leukemia.? Contact us by filling out your information to the right and we’ll respond to you.

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    • 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
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    • Lebanon
    • Lithuania
    • Macedonia
    • Malaysia
    • Mexico
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    • Morocco
    • Netherlands
    • New Zealand
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    • 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

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      Locations

      Contact Us
      Contact Us
      Completed
      Site JP81035
      Sendai, Miyagi, Japan
      Completed
      Site JP81013
      Isehara, Kanagawa, Japan
      Completed
      Site JP81008
      Chiba, Chiba, Japan
      Completed
      Site JP81037
      Anjo, Aichi, Japan
      Completed
      Site JP00001
      Fukuoka, Fukuoka, Japan
      Completed
      Site JP81029
      Akita, Akita, Japan
      Completed
      Site TW88604
      Kaohsiung, Taiwan, Province of China
      Completed
      Site JP81023
      Tsukuba, Ibaraki, Japan
      Completed
      Site JP81038
      Toyohashi, Aichi, Japan
      Completed
      Site JP81001
      Maebashi, Gunma, Japan
      Completed
      Site JP81009
      Okayama, Okayama, Japan
      Completed
      Site JP81028
      Kumamoto, Kumamoto, Japan
      Completed
      Site JP81032
      Shinagawa-ku, Tokyo, Japan
      Completed
      Site JP81016
      Kyoto, Kyoto, Japan
      Completed
      Site JP81019
      Osaka, Osaka, Japan
      Completed
      Site KR82002
      Incheon, Republic of Korea
      Completed
      Site JP00006
      Yokohama, Kanagawa, Japan
      Completed
      Site JP81030
      Gifu, Gifu, Japan
      Completed
      Site JP81003
      Nagoya, Aichi, Japan
      Completed
      Site KR82006
      Seoul, Republic of Korea
      Completed
      Site JP81020
      Kanazawa, Ishikawa, Japan
      Completed
      Site JP81012
      Nagasaki, Nagasaki, Japan
      Completed
      Site JP81018
      Otake, Hiroshima, Japan
      Withdrawn
      Site JP81002
      Shinagawa-ku, Tokyo, Japan
      Completed
      Site JP81036
      Mito, Ibaraki, Japan
      Completed
      Site JP81007
      Yoshida-gun, Fukui, Japan
      Completed
      Site TW88602
      Taichung, Taiwan, Province of China
      Completed
      Site JP81040
      Bunkyo-ku, Tokyo, Japan
      Completed
      Site JP81041
      Tenri, Nara, Japan
      Completed
      Site TW88603
      Taoyuan, Taiwan, Province of China
      Completed
      Site JP81022
      Shimono, Tochigi, Japan
      Completed
      Site JP81004
      Fukuoka, Fukuoka, Japan
      Completed
      Site KR82005
      Busan, Republic of Korea
      Completed
      Site JP81027
      Nagoya, Aichi, Japan
      Completed
      Site KR82004
      Seoul, Republic of Korea
      Completed
      SIte JP81011
      Omura, Nagasaki, Japan
      Completed
      Site JP81033
      Kochi, Kochi, Japan
      Completed
      Site JP81039
      Matsuyama, Ehime, Japan
      Completed
      Site JP81025
      Fukuoka, Fukuoka, Japan
      Completed
      Site JP81024
      Yokohama, Kanagawa, Japan
      Completed
      Site KR82001
      Seoul, Republic of Korea
      Completed
      Site JP81021
      Osaka, Osaka, Japan
      Completed
      Site JP81026
      Fukuyama, Hiroshima, Japan
      Completed
      Site JP81031
      Fukushima, Fukushima, Japan
      Completed
      Site JP00007
      Kobe, Hyogo, Japan
      Withdrawn
      Site JP81017
      Nakagyo-ku, Kyoto, Japan
      Completed
      Site JP00005
      Shinagawa-ku, Tokyo, Japan
      Completed
      Site JP00002
      Maebashi, Gunma, Japan
      Completed
      Site JP81005
      Yokohama, Kanagawa, Japan
      Completed
      Site TW88601
      Tainan, Taiwan, Province of China
      Completed
      Site KR82003
      Seoul, Republic of Korea
      Completed
      Site JP81015
      Sapporo, Hokkaido, Japan
      Completed
      Site JP81014
      Sapporo, Hokkaido, Japan
      Completed
      Site JP81006
      Kobe, Hyogo, Japan
      Completed
      Site JP81010
      Narita, Chiba, Japan
      Completed
      Site JP00003
      Nagoya, Aichi, Japan
      Withdrawn
      Site JP81034
      Suwa, Nagano, Japan
      Completed
      Site JP81043
      Himeji, Hyogo, Japan

      Frequently Asked Questions

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