NCT03315299

Individual Patient Expanded Access Gilteritinib (ASP2215)

Individual Patient Expanded Access for Use of Gilteritinib (ASP2215) for Patient Y.A.

• Status: No Longer Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Etan Orgel · Academic / Other
• Sex: Female
• Age: 12 Years – 15 Years
• Healthy volunteers: —

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.

Conditions

• AML

Interventions

Type	Name	Description
DRUG	ASP2215	Subject will take ASP2215 by mouth daily for 28 day cycles

Timeline

• First posted: 2017-10-20
• Last updated: 2024-02-07

Locations

1 site across 1 country: United States