Ignite Creation Date:
2024-05-06 @ 10:40 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03315299
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2024-02-07
First Post:
2017-10-16
Brief Title:
Individual Patient Expanded Access Gilteritinib ASP2215
Sponsor:
Etan Orgel
Organization:
Childrens Hospital Los Angeles
Study Overview
Official Title:
Individual Patient Expanded Access for Use of Gilteritinib ASP2215 for Patient YA
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to provide expanded access to ASP2215 for a single subject with refractory FLT3-mutated AML without access to comparable or alternative therapy
Detailed Description:
This treatment protocol is being conducted in a single pediatric patient while phase 3 ASP2215 studies are ongoing in adult subjects with FLT3-mutated AML
The subjects will enter the screening period up to 2 weeks prior to the start of treatment
The subject will be administered treatment over 28-day cycles
The subjects will complete visits on cycle 1 days 1 4 8 15 cycle 2 days 1 15 and day 1 of each cycle thereafter until discontinued from the study for toxicity disease progression or lack of continued benefit in the judgement of the investigator
An end of treatment visit will be performed within 7 days after last dose of the investigation product ASP2215 or prior to initiation of another anticancer therapy whichever occurs earlier followed by a 30-day follow up
The subjects will enter the screening period up to 2 weeks prior to the start of treatment
The subject will be administered treatment over 28-day cycles
The subjects will complete visits on cycle 1 days 1 4 8 15 cycle 2 days 1 15 and day 1 of each cycle thereafter until discontinued from the study for toxicity disease progression or lack of continued benefit in the judgement of the investigator
An end of treatment visit will be performed within 7 days after last dose of the investigation product ASP2215 or prior to initiation of another anticancer therapy whichever occurs earlier followed by a 30-day follow up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None