Gilteritinib
Information
- Drug Name
- Gilteritinib
- Description
- Entry(CIViC)
- 1
CIViC
| Disease | Mutation | EL | ET | ED | CS | VO | TR | Pubmed | Links |
|---|---|---|---|---|---|---|---|---|---|
| acute myeloid leukemia | FLT3 MUTATION FLT3 MUTATION | B |
Predictive
|
Supports
|
Sensitivity/Response | Somatic | 4 | 28645776 | Detail |
Annotation
| Description | Associated Genes | Associated Variants | Sensitivity | Supported | Source | Links |
|---|---|---|---|---|---|---|
| In a phase 1-2 trial, patients with refractory or ... | FLT3 | FLT3 MUTATION FLT3 MUTATION | Sensitivity | true | CIViC Evidence | detail |
| NCT ID | Status | Phase | Summary | Start date | Completion date |
|---|---|---|---|---|---|
| NCT02752035 | Active, not recruiting | Phase 3 | 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 | August 1, 2016 | June 30, 2024 |
| NCT05177731 | Active, not recruiting | Phase 3 | Venetoclax + Decitabine vs. "7+3" Induction Chemotherapy in Young AML | March 1, 2022 | December 31, 2024 |
| NCT05791890 | Active, not recruiting | GilteRInf 2022 Study (Gilteritinib Related Infections) | May 31, 2022 | December 31, 2024 | |
| NCT03182244 | Active, not recruiting | Phase 3 | A Study of ASP2215 Versus Salvage Chemotherapy In Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FLT3 Mutation | January 15, 2018 | March 31, 2026 |
| NCT04027309 | Active, not recruiting | Phase 3 | 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 | December 20, 2019 | June 2033 |
| NCT02310321 | Active, not recruiting | Phase 1/Phase 2 | A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia. | February 26, 2015 | July 31, 2024 |
| NCT04140487 | Active, not recruiting | Phase 1/Phase 2 | 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 | December 17, 2019 | September 1, 2025 |
| NCT03836209 | Active, not recruiting | Phase 2 | Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia | December 6, 2019 | December 2024 |
| NCT02421939 | Active, not recruiting | Phase 3 | A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation | October 20, 2015 | July 31, 2024 |
| NCT03070093 | Approved for marketing | 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) | |||
| NCT02014558 | Completed | Phase 1/Phase 2 | Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia | October 9, 2013 | March 7, 2018 |
| NCT02236013 | Completed | Phase 1 | A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia | January 7, 2015 | July 26, 2021 |
| NCT02456883 | Completed | Phase 1 | Study to Investigate the Absorption, Metabolism and Excretion of [14C] ASP2215 in Patients With Advanced Solid Tumors | March 4, 2016 | June 19, 2017 |
| NCT02561455 | Completed | Phase 1/Phase 2 | Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial | May 3, 2016 | July 28, 2020 |
| NCT02927262 | Completed | Phase 2 | 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 | January 10, 2017 | February 19, 2024 |
| NCT02997202 | Completed | Phase 3 | 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) | June 7, 2017 | May 9, 2023 |
| NCT03625505 | Completed | Phase 1 | A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia | October 18, 2018 | August 31, 2021 |
| NCT03730012 | Completed | Phase 1/Phase 2 | 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) | June 19, 2019 | June 15, 2021 |
| NCT03964038 | Completed | Phase 1 | 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 | May 21, 2019 | July 16, 2019 |
| NCT02181660 | Completed | Phase 1 | Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of ASP2215 in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia | June 16, 2014 | June 27, 2016 |
| NCT04699877 | Completed | Phase 1 | A Study to Investigate the Effect of Severe Renal Impairment on Gilteritinib Compared to Healthy Participants With Normal Renal Function | January 28, 2021 | July 18, 2022 |
| NCT03409081 | No longer available | 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) | |||
| NCT06317649 | Not yet recruiting | Phase 2 | Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial) | May 30, 2024 | October 31, 2025 |
| NCT06001788 | Recruiting | Phase 1 | Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia | February 22, 2024 | August 2027 |
| NCT02115295 | Recruiting | Phase 2 | Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia | May 19, 2014 | May 31, 2026 |
| NCT04240002 | Recruiting | Phase 1/Phase 2 | 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) | September 4, 2020 | August 31, 2031 |
| NCT05010122 | Recruiting | Phase 1/Phase 2 | ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome | July 8, 2021 | January 30, 2025 |
| NCT05010772 | Recruiting | Phase 1 | Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission | October 25, 2021 | December 31, 2026 |
| NCT05024552 | Recruiting | Phase 1 | Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML | August 23, 2021 | August 2025 |
| NCT06221683 | Recruiting | Phase 2 | Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML | March 2024 | December 2029 |
| NCT06222580 | Recruiting | Phase 1 | SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation | February 20, 2024 | December 31, 2025 |
| NCT06225427 | Recruiting | Phase 1 | Gilteritinib for the Treatment of ALK NSCLC | May 2024 | March 2027 |
| NCT06235801 | Recruiting | Phase 1/Phase 2 | A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia | May 22, 2024 | October 1, 2029 |
| NCT05312112 | Recruiting | Real World Outcomes Using Novel Agents for AML in the UK | May 1, 2022 | October 1, 2023 | |
| NCT05520567 | Recruiting | Phase 1/Phase 2 | A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia | January 27, 2023 | July 31, 2028 |
| NCT05564390 | Recruiting | Phase 2 | MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial) | February 10, 2025 | May 15, 2029 |
| NCT05756777 | Recruiting | Phase 1 | A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML) | June 26, 2023 | February 2025 |
| NCT05955261 | Recruiting | Phase 2 | A Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia | July 25, 2023 | March 2034 |
| NCT04336982 | Terminated | Phase 1 | A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia | August 5, 2020 | April 5, 2024 |
| NCT05028751 | Terminated | Phase 1/Phase 2 | A Study to Evaluate Lanraplenib (LANRA) in Combination With Gilteritinib in Participants With FLT3-mutated Relapsed or Refractory Acute Myeloid Leukemia (AML) | August 5, 2022 | April 9, 2024 |
| NCT02495233 | Terminated | Phase 1/Phase 2 | 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) | September 8, 2015 | September 28, 2016 |
| NCT05279859 | Withdrawn | Phase 1/Phase 2 | A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Hematologic Malignancies | March 15, 2022 | June 1, 2025 |