Gilteritinib

Generic Name
Gilteritinib
Brand Names
Xospata
Drug Type
Small Molecule
Chemical Formula
C29H44N8O3
CAS Number
1254053-43-4
Unique Ingredient Identifier
66D92MGC8M
Background

Gilteritinib, also known as ASP2215, is a small molecule part of the FLT3 tyrosine kinase inhibitors that presented a greater selectivity and potency when compared with other agents from this group. It is a pyrazinecarboxamide derivative that showed high selectivity to FLT3 preventing the c-Kit -driven myelosuppression observed in other therapies. Gilteritin...

Indication

Gilteritinib is indicated for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia with an FLT3 mutation detected by an FDA-approved test. This indication was expanded for a companion diagnostic to include use with gilteritinib such as the LeukoStrat CDx FLT3 Mutation Assay.
...

Associated Conditions
Relapsed or Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
Associated Therapies
-

A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia.

First Posted Date
2014-12-08
Last Posted Date
2024-11-28
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
97
Registration Number
NCT02310321
Locations
🇯🇵

Site JP81037, Anjo, Aichi, Japan

🇯🇵

Site JP00003, Nagoya, Aichi, Japan

🇯🇵

Site JP81003, Nagoya, Aichi, Japan

and more 52 locations

A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia

First Posted Date
2014-09-10
Last Posted Date
2024-11-05
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
80
Registration Number
NCT02236013
Locations
🇺🇸

Site US10003, Los Angeles, California, United States

🇺🇸

Site US10013, New Haven, Connecticut, United States

🇺🇸

Site US10004, Chicago, Illinois, United States

and more 7 locations

Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of ASP2215 in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-07-04
Last Posted Date
2024-11-06
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
24
Registration Number
NCT02181660
Locations
🇯🇵

Site JP00001, Gunma, Japan

🇯🇵

Site JP00004, Tokyo, Japan

🇯🇵

Site JP00005, Tokyo, Japan

and more 2 locations

Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia

First Posted Date
2013-12-18
Last Posted Date
2024-12-03
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
265
Registration Number
NCT02014558
Locations
🇺🇸

Site US10018, Hershey, Pennsylvania, United States

🇺🇸

Site US10015, Chicago, Illinois, United States

🇺🇸

Site US10020, Hackensack, New Jersey, United States

and more 23 locations
© Copyright 2024. All Rights Reserved by MedPath