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

Astellas

Status and phase: Completed; Phase 2; Phase 1

Conditions: Advanced Solid Tumors; Acute Myeloid Leukemia

Treatments: Drug: Gilteritinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02561455

2215-CL-0109

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 4 patient groups

Gilteritinib 40 mg

Experimental group

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.

Treatment:

Drug: Gilteritinib

Gilteritinib 80 mg

Experimental group

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.

Treatment:

Drug: Gilteritinib

Gilteritinib 120 mg

Experimental group

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.

Treatment:

Drug: Gilteritinib

Gilteritinib 200 mg

Experimental group

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.

Treatment:

Drug: Gilteritinib