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
- -
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)
- 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
A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation
- Conditions
- Interventions
- First Posted Date
- 2017-06-09
- Last Posted Date
- 2024-08-29
- Lead Sponsor
- Astellas Pharma Inc
- Target Recruit Count
- 276
- Registration Number
- NCT03182244
- Locations
- 🇨🇳
Site CN123, Huangpu Qu, China
🇨🇳Site CN117, Jinan, China
🇨🇳Site CN133, Lanzhou, China
Expanded Access Study of Gilteritinib (ASP2215) in Patients With FMS-like Tyrosine Kinase 3 (FLT3) Mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) or FLT3-Mutated AML in Complete Remission (CR) With Minimal Residual Disease (MRD)
- First Posted Date
- 2017-03-03
- Last Posted Date
- 2021-04-20
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Registration Number
- NCT03070093
- Locations
- 🇺🇸
University of Maryland Medical Center, Baltimore, Maryland, United States
🇺🇸The Sidney Kimmel Comprehensive Cancer Center -Johns Hopkins University, Baltimore, Maryland, United States
🇺🇸UPCI, Pittsburgh, Pennsylvania, United States
A Trial of the FMS-like Tyrosine Kinase 3 (FLT3) Inhibitor Gilteritinib Administered as Maintenance Therapy Following Allogeneic Transplant for Patients With FLT3/Internal Tandem Duplication (ITD) Acute Myeloid Leukemia (AML)
- First Posted Date
- 2016-12-19
- Last Posted Date
- 2024-12-17
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 356
- Registration Number
- NCT02997202
- Locations
- 🇮🇹
Site IT39009, Genova, Italy
🇩🇪Site DE49007, Mainz, Germany
🇮🇹Site IT39004, Udine, Italy
A Study of ASP2215 (Gilteritinib), Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FMS-like Tyrosine Kinase 3 (FLT3/ITD) Acute Myeloid Leukemia (AML) in First Complete Remission
- First Posted Date
- 2016-10-07
- Last Posted Date
- 2024-11-26
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 98
- Registration Number
- NCT02927262
- Locations
- 🇫🇷
Site FR33014, Vandoeuvre les Nancy, Meurthe-et-Moselle, France
🇬🇧Site GB44007, Exeter, Devon, United Kingdom
🇯🇵Site JP81011, Tachikawa, Tokyo, Japan
A Study of ASP2215 (Gilteritinib) by Itself, ASP2215 Combined With Azacitidine or Azacitidine by Itself to Treat Adult Patients Who Have Recently Been Diagnosed With Acute Myeloid Leukemia With a FLT3 Gene Mutation and Who Cannot Receive Standard Chemotherapy
- Conditions
- Interventions
- First Posted Date
- 2016-04-26
- Last Posted Date
- 2024-12-05
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 183
- Registration Number
- NCT02752035
- Locations
- 🇺🇸
Robert H. Lurie Comprehensive Cancer Center, Chicago, Illinois, United States
🇺🇸Rush University Medical Center, Chicago, Illinois, United States
🇺🇸UCLA David Geffen School of Medicine, Los Angeles, California, United States
Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial
- Conditions
- Interventions
- First Posted Date
- 2015-09-28
- Last Posted Date
- 2024-11-19
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 9
- Registration Number
- NCT02561455
- Locations
- 🇺🇸
Site US10005, Phoenix, Arizona, United States
🇺🇸Site US10003, Baltimore, Maryland, United States
🇺🇸Site US10006, New York, New York, United States
A Study of ASP2215 in Combination With Erlotinib in Subjects With Epidermal Growth Factor Receptor (EGFR) Activating Mutation-Positive (EGFRm+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI)
- First Posted Date
- 2015-07-13
- Last Posted Date
- 2024-11-27
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 10
- Registration Number
- NCT02495233
- Locations
- 🇯🇵
Site JP81005, Osakasayama, Osaka, Japan
🇯🇵Site JP81004, Fukuoka Minami-ku, Fukuoka, Japan
🇯🇵Site JP81003, Suntogun Nagaizumicho,Shizuoka, Japan
Study to Investigate the Absorption, Metabolism and Excretion of [14C] ASP2215 in Patients With Advanced Solid Tumors
- Conditions
- Interventions
- First Posted Date
- 2015-05-29
- Last Posted Date
- 2024-11-05
- Lead Sponsor
- Astellas Pharma Global Development, Inc.
- Target Recruit Count
- 6
- Registration Number
- NCT02456883
- Locations
- 🇺🇸
Site US10001, Cleveland, Ohio, United States
A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation
- First Posted Date
- 2015-04-21
- Last Posted Date
- 2024-12-19
- 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
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.