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

Primary Purpose

Advanced Solid Tumors, Acute Myeloid Leukemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Gilteritinib
Sponsored by
Astellas Pharma Global Development, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumors focused on measuring Advanced solid tumors, Acute myeloid leukemia, gilteritinib, ASP2215

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site US10005
  • Site US10003
  • Site US10006
  • Site US10007
  • Site US10001
  • Site US10004
  • Site US10008

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Gilteritinib 40 mg

Gilteritinib 80 mg

Gilteritinib 120 mg

Gilteritinib 200 mg

Arm Description

Participants received gilteritinib 40 milligrams (mg) dose (one tablet of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occured, or met one of the treatment discontinuation criteria.

Participants received gilteritinib 80 mg dose (two tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occured, or met one of the treatment discontinuation criteria.

Participants received gilteritinib 120 mg dose (three tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occured, or met one of the treatment discontinuation criteria.

Participants received gilteritinib 200 mg dose (five tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occured, or met one of the treatment discontinuation criteria.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events
AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures and which did not necessarily have a causal relationship with this treatment. An abnormality identified during a medical test (e.g., laboratory parameter, vital sign, Electrocardiography (ECG) data, and physical exam) was defined as an AE only if the abnormality induces clinical signs or symptoms or requires active intervention or requires interruption or discontinuation of study medication or the abnormality or investigational value is clinically significant in the opinion of the investigator.
Eastern Cooperative Oncology Group (ECOG) Performance Status at End Of Treattment Visit (EOT)
ECOG performance status was used to assess participants disease progression, and ability to carry out the daily living activities. The participants were graded on a scale of 0 to 5 where 0 = fully active, able to carry on all predisease performance without restriction; 1 = restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = capable of only limited self-care,confined to bed or chair more than 50% of waking hours; 4 = completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5 = Dead. Number of participants with ECOG performance status was reported.

Secondary Outcome Measures

Full Information

First Posted
September 25, 2015
Last Updated
September 16, 2021
Sponsor
Astellas Pharma Global Development, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02561455
Brief Title
Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial
Official Title
A Phase 1/2 Open-label Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
May 3, 2016 (Actual)
Primary Completion Date
July 28, 2020 (Actual)
Study Completion Date
July 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Global Development, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumors, Acute Myeloid Leukemia
Keywords
Advanced solid tumors, Acute myeloid leukemia, gilteritinib, ASP2215

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gilteritinib 40 mg
Arm Type
Experimental
Arm Description
Participants received gilteritinib 40 milligrams (mg) dose (one tablet of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occured, or met one of the treatment discontinuation criteria.
Arm Title
Gilteritinib 80 mg
Arm Type
Experimental
Arm Description
Participants received gilteritinib 80 mg dose (two tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occured, or met one of the treatment discontinuation criteria.
Arm Title
Gilteritinib 120 mg
Arm Type
Experimental
Arm Description
Participants received gilteritinib 120 mg dose (three tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occured, or met one of the treatment discontinuation criteria.
Arm Title
Gilteritinib 200 mg
Arm Type
Experimental
Arm Description
Participants received gilteritinib 200 mg dose (five tablets of 40 mg) orally once a day in continuous 28-day cycles at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants no longer received clinical benefit from therapy, or unacceptable toxicity occured, or met one of the treatment discontinuation criteria.
Intervention Type
Drug
Intervention Name(s)
Gilteritinib
Other Intervention Name(s)
ASP2215
Intervention Description
oral tablet
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
AE was defined as any untoward medical occurrence in a participant administered a study drug or has undergone study procedures and which did not necessarily have a causal relationship with this treatment. An abnormality identified during a medical test (e.g., laboratory parameter, vital sign, Electrocardiography (ECG) data, and physical exam) was defined as an AE only if the abnormality induces clinical signs or symptoms or requires active intervention or requires interruption or discontinuation of study medication or the abnormality or investigational value is clinically significant in the opinion of the investigator.
Time Frame
From first dose of study drug up to 30 days after last dose of study drug (median treatment duration was 811.0 days, minimum of 43 days and maximum of 1067 days)
Title
Eastern Cooperative Oncology Group (ECOG) Performance Status at End Of Treattment Visit (EOT)
Description
ECOG performance status was used to assess participants disease progression, and ability to carry out the daily living activities. The participants were graded on a scale of 0 to 5 where 0 = fully active, able to carry on all predisease performance without restriction; 1 = restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2 = ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = capable of only limited self-care,confined to bed or chair more than 50% of waking hours; 4 = completely disabled. Cannot carry on any self-care. Totally confined to bed or chair; 5 = Dead. Number of participants with ECOG performance status was reported.
Time Frame
EOT Visit (30 days post-last dose, maximum treatement duration of 1067 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Executive Medical Director
Organizational Affiliation
Astellas Pharma Global Development, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Site US10005
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85084
Country
United States
Facility Name
Site US10003
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Site US10006
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Site US10007
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Site US10001
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Site US10004
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Site US10008
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Links:
URL
https://astellasclinicalstudyresults.com/patientStudySearch.aspx?RID=;;;2215-CL-0109
Description
Link to results on the Astellas Clinical Study Results website.

Learn more about this trial

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

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