Clinical trial NCT02561455: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Acute Myeloid Leukemia
Keywords: Advanced solid tumors
Acute myeloid leukemia
gilteritinib
ASP2215
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2015-09-28
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 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)
measure: Eastern Cooperative Oncology Group (ECOG) Performance Status at End Of Treattment Visit (EOT)
timeFrame: EOT Visit (30 days post-last dose, maximum treatement duration of 1067 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Site US10005
state: Arizona
city: Baltimore
country: United States
facility: Site US10003
state: Maryland
city: New York
country: United States
facility: Site US10006
state: New York
city: New York
country: United States
facility: Site US10007
state: New York
city: Cleveland
country: United States
facility: Site US10001
state: Ohio
city: Hershey
country: United States
facility: Site US10004
state: Pennsylvania
city: Philadelphia
country: United States
facility: Site US10008
state: Pennsylvania
Study officials:
affiliation: Astellas Pharma Global Development, Inc.
name: Executive Medical Director
role: STUDY_DIRECTOR
References: