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Astellas Study ID
2215-CL-0109

Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial

Astellas Study ID
2215-CL-0109
Clinicaltrials.gov ID
NCT02561455
EUCTIS ID
N/A
EudraCT ID
N/A
jRCT ID
N/A
CN CDE ID
N/A
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Study summary

The purpose of the study was to provide access to continued treatment for those who participated in other Astellas sponsored ASP2215 trials that completed the primary analysis and, had the potential to continue to derive clinical benefit from the treatment with ASP2215, and who did not meet any of the study discontinuation criteria in the present study.

Additional Study Details

Phase
1/2
Product
N/A
Product
Gilteritinib
Type
Interventional
Masking
None (Open Label)
Enrollment number
9
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Study documents

Scientific Results Summary
Available Language(s): English
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Plain Language Summary
Available Language(s): English
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Protocol
Available Language(s): English
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Statistical Analysis Plan (SAP)
Available Language(s): English
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Would you like more information about clinical trial sites that are recruiting participants for Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial? 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

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    Completed
    Site US10008
    Philadelphia, PA, United States, 19104
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    Completed
    Site US10001
    Cleveland, OH, United States, 44195
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    Completed
    Site US10004
    Hershey, PA, United States, 17033
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    Completed
    Site US10003
    Baltimore, MD, United States, 21201
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    Completed
    Site US10005
    Phoenix, AZ, United States, 85084
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    Completed
    Site US10006
    New York, NY, United States, 10032
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    Completed
    Site US10007
    New York, NY, United States, 10065
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    Trial info
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    Age
    18+ years
    Diamond icon
    Condition
  • Advanced/Metastatic Cancer
    • Show more
  • Leukemia - AML
    • Gender icon
    Sex
    Female & Male
    Calendar icon
    Trial Dates
    May 2016 - Jul 2020
    Additional Study Details
    Inclusion Criteria
    • Subject must currently be participating in an Astellas sponsored, single agent ASP2215 trial, receiving ASP2215 and have not met any discontinuation criteria of the parent study and can enroll into this rollover study without interruption of study drug, or with no more than 2 weeks interruption in study drug.
    • Subject must be deriving benefit from continued treatment without any persistent intolerable toxicity from continued treatment of ASP2215.
    • Female subject must either:
      • Be of non-childbearing potential: post-menopausal (defined as at least 1 year without any menses) prior to Screening, or documented surgically sterile or post-hysterectomy (at least 1 month prior to Screening)
      • Or, if of childbearing potential, Agree not to try to become pregnant during the study and for 180 days after the final study drug administration; And have a negative urine pregnancy test at Day 1; And, if heterosexually active, agree to consistently use two forms of highly effective birth control (at least one of which must be a barrier method) starting at Screening and throughout the study period and for 180 days after the final study drug administration.
    • Female subject must agree not to breastfeed starting at Screening and throughout the study period, and for 60 days after the final study drug administration.
    • Female subject must not donate ova starting at Screening and throughout the study period, and for 180 days after the final study drug administration.
    • Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control (at least one of which must be a barrier method) starting at Screening and continue throughout the study period, and for 120 days after the final study drug administration.
    • Male subject must not donate sperm starting at Screening and throughout the study period and, for 120 days after the final study drug administration.
    • Subject agrees not to participate in another interventional study while on treatment.
    MaximizeExclusion Criteria
    • Subject requires treatment with concomitant drugs that are strong inducers of cytochrome P450 (CYP)3A.
    • Subject requires treatment with concomitant drugs that target serotonin 5-hydroxytryptamine receptor 1 (5HT1R) or 5-hydroxytryptamine receptor 2B (5HT2BR) or sigma nonspecific receptor with the exception of drugs that are considered absolutely essential for the care of the subject.
    • Subject requires treatment with concomitant drugs that are strong inhibitors or inducers of P-glycoprotein (P-gp) with the exception of drugs that are considered absolutely essential for the care of the subject.

    Frequently Asked Questions

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    Sometimes researchers want participants to keep taking their current treatments during a clinical trial. Other times, you may need to stop your current treatments for a while. If the investigational treatment doesn't work, you can usually go back to your original treatment plan.

    Should I be worried about getting a placebo?

    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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