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. Gilteritinib was developed by Astellas Pharma and FDA approved on November 28, 2018. This drug was approved after being designed as an orphan drug with a fast track and priority review status.
- 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.
Acute myeloid leukemia is cancer that impacts the blood and bone marrow with a rapid progression. This condition produces low numbers of normal blood cells and the requirement of continuous need for transfusions.
- Associated Conditions
- Relapsed or Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation
- Conditions
- Leukemia, Acute Myeloid (AML)
- Interventions
- Drug: LoDAC (Low Dose Cytarabine)Drug: MEC (Mitoxantrone, Etoposide, Cytarabine)Drug: FLAG-IDA (Granulocyte-Colony Stimulating Factor (G-CSF), Fludarabine, Cytarabine, Idarubicin)
- First Posted Date
- 2015-04-21
- Last Posted Date
- 2025-03-28
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 371
- Registration Number
- NCT02421939
- Locations
- 🇵🇱
Site PL48004, Wroclaw, Poland
🇺🇸Site US10044, Cleveland, Ohio, United States
🇺🇸Site US10034, Boston, Massachusetts, United States
A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia.
- Conditions
- Acute Myeloid LeukemiaFLT3-mutated Acute Myeloid Leukemia
- Interventions
- 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
A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia
- Conditions
- Acute Myeloid Leukemia
- Interventions
- 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
Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of ASP2215 in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia
- 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
Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia
- Conditions
- Acute Biphenotypic LeukemiaAcute Myeloid LeukemiaBlast Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveBlasts 10 Percent or More of Bone Marrow Nucleated CellsBlasts 10 Percent or More of Peripheral Blood White Cellsde Novo Myelodysplastic SyndromeMyelodysplastic SyndromePreviously Treated Myelodysplastic SyndromeRecurrent Acute Myeloid LeukemiaRecurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Interventions
- Other: Laboratory Biomarker Analysis
- First Posted Date
- 2014-04-16
- Last Posted Date
- 2025-05-11
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 508
- Registration Number
- NCT02115295
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
- Conditions
- Acute Myeloid Leukemia
- Interventions
- 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
Drug Development Updates
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