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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
Clinical Trials
Related News

A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase 3 (FLT3) Mutation

Phase 3
Active, not recruiting
Conditions
AML With FLT3 Mutation
Interventions
First Posted Date
2017-06-09
Last Posted Date
2025-05-09
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

and more 46 locations

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)

Conditions
Acute Myeloid Leukemia (AML)
FMS-like Tyrosine Kinase-3 (FLT3) Mutations
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

and more 36 locations

Study of Biomarker-Based Treatment of Acute Myeloid Leukemia

Phase 1
Recruiting
Conditions
Previously Untreated Relapsed Refractory Acute Myeloid Leukemia
Interventions
Biological: BI 836858 (BAML-16-001-S2)
Drug: ZE46-0134 (BAML-16-001-S21)
Other: Laboratory Biomarker Analysis
Drug: AG-221 (BAML-16-001-S3)
Drug: AG-120 (BAML-16-001-S16)
Drug: AZD5153 (BAML-16-001-S10)
Drug: TP-0903 (BAML-16-001-S14)
Drug: AZD5991 (BAML-16-001-S18)
Drug: SNDX-5613 (BAML-16-001-S17)
First Posted Date
2017-01-09
Last Posted Date
2024-02-21
Lead Sponsor
Beat AML, LLC
Target Recruit Count
2000
Registration Number
NCT03013998
Locations
🇺🇸

Mayo Clinic Arizona, Phoenix, Arizona, United States

🇺🇸

UCLA Ronald Reagan Medical Center, Los Angeles, California, United States

🇺🇸

University of California, San Francisco, San Francisco, California, United States

and more 16 locations

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)

Phase 3
Completed
Conditions
Acute Myeloid Leukemia
Interventions
Drug: Placebo
First Posted Date
2016-12-19
Last Posted Date
2025-01-17
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

and more 114 locations

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

Phase 2
Completed
Conditions
Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation
Interventions
Drug: Placebo
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

and more 70 locations

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

Phase 3
Completed
Conditions
Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation
Interventions
First Posted Date
2016-04-26
Last Posted Date
2024-12-27
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

and more 108 locations

A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP2215

Phase 1
Completed
Conditions
Hepatic Impairment
Healthy
Interventions
First Posted Date
2015-10-08
Last Posted Date
2024-11-05
Lead Sponsor
Astellas Pharma Global Development, Inc.
Target Recruit Count
24
Registration Number
NCT02571816
Locations
🇺🇸

Site US10001, Miami, Florida, United States

Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial

Phase 1
Completed
Conditions
Advanced Solid Tumors
Acute Myeloid Leukemia
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

and more 4 locations

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)

Phase 1
Terminated
Conditions
Non-Small-Cell Lung Cancer
Interventions
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

and more 1 locations

Study to Investigate the Absorption, Metabolism and Excretion of [14C] ASP2215 in Patients With Advanced Solid Tumors

Phase 1
Completed
Conditions
Pharmacokinetics of 14C-labeled Gilteritinib
Advanced Solid Tumors
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

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