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 to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Procedure: Allogeneic Hematopoietic Stem Cell TransplantationProcedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyProcedure: Computed TomographyOther: Fludeoxyglucose F-18Drug: Liposome-encapsulated Daunorubicin-CytarabineProcedure: Magnetic Resonance ImagingProcedure: Positron Emission TomographyOther: Questionnaire Administration
- First Posted Date
- 2020-03-03
- Last Posted Date
- 2025-05-04
- Lead Sponsor
- Children's Oncology Group
- Target Recruit Count
- 1186
- Registration Number
- NCT04293562
- Locations
- 🇨🇦
Kingston Health Sciences Centre, Kingston, Ontario, Canada
🇺🇸Banner Children's at Desert, Mesa, Arizona, United States
🇺🇸Children's Hospital of Alabama, Birmingham, Alabama, United States
A Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
- Conditions
- Acute Myeloid Leukemia (AML)Acute Myeloid Leukemia With FMS-like Tyrosine Kinase 3 (FLT3) Mutation / Internal Tandem Duplication (ITD)
- Interventions
- Drug: granulocyte colony-stimulating factor (G-CSF)
- First Posted Date
- 2020-01-27
- Last Posted Date
- 2025-04-16
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 9
- Registration Number
- NCT04240002
- Locations
- 🇺🇸
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
🇩🇪Site DE49004, Essen, Nordrhein-Westfalen, Germany
🇮🇹SIte IT39001, Roma, Italy
Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm
- Conditions
- Refractory Acute Myeloid LeukemiaRecurrent Chronic Myelomonocytic LeukemiaRecurrent Myelodysplastic/Myeloproliferative NeoplasmRefractory Chronic Myelomonocytic LeukemiaRefractory Myelodysplastic/Myeloproliferative NeoplasmRecurrent Acute Myeloid Leukemia
- Interventions
- First Posted Date
- 2019-10-28
- Last Posted Date
- 2025-05-01
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 97
- Registration Number
- NCT04140487
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy
- Conditions
- Acute Myeloid LeukemiaMyelodysplastic Syndrome With Excess Blasts-2
- Interventions
- First Posted Date
- 2019-07-19
- Last Posted Date
- 2024-12-17
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland
- Target Recruit Count
- 777
- Registration Number
- NCT04027309
- Locations
- 🇦🇺
AU-Adelaide-FLINDERS, Adelaide, Australia
🇦🇺AU-Adelaide-RAH, Adelaide, Australia
🇦🇺AU-Brisbane-PAH, Brisbane, Australia
A Study to Assess the Relative Bioavailability of Gilteritinib Following a Single Dose of Gilteritinib Mini-tablet Oral Suspension and Gilteritinib Mini-tablets Compared to a Single Dose of Gilteritinib Tablet in Healthy Subjects
- Conditions
- Healthy Volunteer
- Interventions
- First Posted Date
- 2019-05-28
- Last Posted Date
- 2024-10-16
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 48
- Registration Number
- NCT03964038
- Locations
- 🇺🇸
EPCU - Parexel, Baltimore, Maryland, United States
Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia
- Conditions
- Acute Myeloid Leukemia
- Interventions
- First Posted Date
- 2019-02-11
- Last Posted Date
- 2025-02-28
- Lead Sponsor
- PrECOG, LLC.
- Target Recruit Count
- 181
- Registration Number
- NCT03836209
- Locations
- 🇺🇸
UCLA, Los Angeles, California, United States
🇺🇸University of Rochester Medical Center, Rochester, New York, United States
🇺🇸HonorHealth Research Institute, Scottsdale, Arizona, United States
A Study of ASP2215 (Gilteritinib) Combined With Atezolizumab in Patients With Relapsed or Treatment Refractory FMS-like Tyrosine Kinase (FLT3) Mutated Acute Myeloid Leukemia (AML)
- Conditions
- Acute Myeloid Leukemia (AML)Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation
- Interventions
- First Posted Date
- 2018-11-05
- Last Posted Date
- 2024-11-28
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 11
- Registration Number
- NCT03730012
- Locations
- 🇺🇸
Medical College of Wisconsin, Milwaukee, Wisconsin, United States
🇺🇸Vanderbilt Ingram Cancer Center, Nashville, Tennessee, United States
🇺🇸University of Kentucky, Lexington, Kentucky, United States
A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia
- Conditions
- Acute Myeloid Leukemia (AML)
- Interventions
- First Posted Date
- 2018-08-10
- Last Posted Date
- 2021-09-14
- Lead Sponsor
- AbbVie
- Target Recruit Count
- 61
- Registration Number
- NCT03625505
- Locations
- 🇺🇸
Northwestern Memorial Hospital /ID# 200230, Chicago, Illinois, United States
🇺🇸Sylvester Comprehensive Cancer /ID# 200268, Miami, Florida, United States
🇺🇸David Geffen School of Medicin /ID# 200166, Los Angeles, California, United States
Early Access Program (EAP) of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or With FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)
- Conditions
- Acute Myeloid Leukemia (AML)FMS-like Tyrosine Kinase-3 (FLT3) Mutations
- First Posted Date
- 2018-01-24
- Last Posted Date
- 2018-09-13
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Registration Number
- NCT03409081
- Locations
- 🇮🇹
Site IT39001, Milan, Italy
🇦🇺Site AU61001, Canberra, Australia
🇬🇧Site UK44001, Birmingham, United Kingdom
Individual Patient Expanded Access Gilteritinib (ASP2215)
- Conditions
- AML
- First Posted Date
- 2017-10-20
- Last Posted Date
- 2024-02-07
- Lead Sponsor
- Etan Orgel
- Registration Number
- NCT03315299
- Locations
- 🇺🇸
Children's Hospital Los Angeles, Los Angeles, California, United States
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.