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
- -
Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission
- Conditions
- Interventions
- First Posted Date
- 2021-08-18
- Last Posted Date
- 2024-11-20
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 125
- Registration Number
- NCT05010772
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
A Study to Investigate the Effect of Severe Renal Impairment on Gilteritinib Compared to Healthy Participants With Normal Renal Function
- Conditions
- Interventions
- First Posted Date
- 2021-01-07
- Last Posted Date
- 2024-11-05
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 17
- Registration Number
- NCT04699877
- Locations
- 🇺🇸
Orange County Research Institute, Tustin, California, United States
🇺🇸National Institute of Clinical Research, Garden Grove, California, United States
🇺🇸Orlando Clinical Research Center, Orlando, Florida, United States
A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia
- Conditions
- Interventions
- First Posted Date
- 2020-04-07
- Last Posted Date
- 2024-05-31
- Lead Sponsor
- Celgene
- Target Recruit Count
- 22
- Registration Number
- NCT04336982
- Locations
- 🇺🇸
Local Institution - 104, San Francisco, California, United States
🇺🇸Local Institution - 103, Boston, Massachusetts, United States
🇨🇦Local Institution - 201, Toronto, Ontario, Canada
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)
- First Posted Date
- 2020-01-27
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 97
- Registration Number
- NCT04240002
- Locations
- 🇩🇪
Site DE49001, Halle (Saale), Sachsen-Anhalt, Germany
🇮🇹SIte IT39001, Roma, Italy
🇺🇸Sarah Cannon Research Institute, Nashville, Tennessee, United States
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
- Interventions
- First Posted Date
- 2019-10-28
- Last Posted Date
- 2024-10-24
- 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
- Interventions
- First Posted Date
- 2019-07-19
- Last Posted Date
- 2024-12-17
- 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
- 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
- Interventions
- First Posted Date
- 2019-02-11
- Last Posted Date
- 2024-02-22
- 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
- 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
- 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
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.