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Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

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

NCT02561455•Astellas Pharma Global Development, Inc.

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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.

Locations (7)

Site US10005

Phoenix, Arizona, United States

Site US10003

Baltimore, Maryland, United States

Site US10006

New York, New York, United States

Site US10007

New York, New York, United States

Site US10001

Cleveland, Ohio, United States

Site US10004

Hershey, Pennsylvania, United States

Site US10008

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

May 3, 2016

Primary Completion Date

July 28, 2020

Completion Date

July 28, 2020

Last Updated

November 19, 2024

Enrollment

ACTUAL participants

Conditions

Advanced Solid TumorsAcute Myeloid Leukemia

Interventions

Gilteritinib

DRUG

Phase I Study of HC-7366 for Acute Myeloid Leukemia

NCT06285890

Acute Myeloid Leukemia

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RECRUITINGPHASE1/PHASE2

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

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RECRUITINGPHASE2

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 19, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

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