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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02561455
Recruitment Status : Completed
First Posted : September 28, 2015
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Brief Summary:
The purpose of the study is to provide access to continued treatment for subjects who participated in other Astellas sponsored ASP2215 trials that completed the primary analysis and for whom the Investigator feels may have 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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Acute Myeloid Leukemia Drug: gilteritinib Phase 1 Phase 2

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Open-label Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial
Actual Study Start Date : April 28, 2016
Actual Primary Completion Date : July 24, 2020
Actual Study Completion Date : July 24, 2020


Arm Intervention/treatment
Experimental: ASP2215
Subject will continue dosing at the dose received in original study.
Drug: gilteritinib
oral
Other Name: ASP2215




Primary Outcome Measures :
  1. Safety assessed by Adverse Events (AEs) [ Time Frame: Until End of Treatment (up to 2 years) ]
  2. Safety assessed by safety laboratory evaluations [ Time Frame: Until End of Treatment (up to 2 years) ]
    Safety laboratory tests include chemistry, hematology, serum pregnancy, coagulation and urinalysis



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Exclusion 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.

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 ClinicalTrials.gov identifier (NCT number): NCT02561455


Locations
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United States, Arizona
Site US10005
Phoenix, Arizona, United States, 85084
United States, Maryland
Site US10003
Baltimore, Maryland, United States, 21201
United States, New York
Site US10006
New York, New York, United States, 10032
Site US10007
New York, New York, United States, 10065
United States, Ohio
Site US10001
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Site US10004
Hershey, Pennsylvania, United States, 17033
Site US10008
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Investigators
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Study Director: Executive Medical Director Astellas Pharma Global Development, Inc.
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Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT02561455    
Other Study ID Numbers: 2215-CL-0109
First Posted: September 28, 2015    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
Advanced solid tumors
Acute myeloid leukemia
gilteritinib
ASP2215
Additional relevant MeSH terms:
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Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms