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

Acute Myeloid Leukemia Clinical Trial

Official title:

A Phase 1/2 Open-label Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02561455
• Other study ID #: 2215-CL-0109
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: May 3, 2016
• Est. completion date: July 28, 2020

Study information

• Verified date: September 2021
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: July 28, 2020
• Est. primary completion date: July 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Advanced Solid Tumors
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Gilteritinib
oral tablet

Locations

Country	Name	City	State
United States	Site US10003	Baltimore	Maryland
United States	Site US10001	Cleveland	Ohio
United States	Site US10004	Hershey	Pennsylvania
United States	Site US10006	New York	New York
United States	Site US10007	New York	New York
United States	Site US10008	Philadelphia	Pennsylvania
United States	Site US10005	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Global Development, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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)
Primary	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.	EOT Visit (30 days post-last dose, maximum treatement duration of 1067 days)

External Links

•   Link to results on the Astellas Clinical Study Results website.