{"id":"asp2215","safety":{"commonSideEffects":[{"rate":"40-50%","effect":"Neutropenia"},{"rate":"30-40%","effect":"Diarrhea"},{"rate":"20-30%","effect":"Vomiting"},{"rate":"20-30%","effect":"Fatigue"},{"rate":"20-30%","effect":"Nausea"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"groq-llama-8b","explanation":"ALK is a protein that, when mutated or overexpressed, can contribute to the development and progression of certain cancers. ASP2215 works by blocking the activity of the ALK protein, which can help slow or stop the growth of cancer cells.","oneSentence":"ASP2215 is a selective and potent inhibitor of the anaplastic lymphoma kinase (ALK) receptor tyrosine kinase.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T03:21:32.176Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Non-small cell lung cancer with ALK rearrangement"},{"name":"Ceritinib-resistant non-small cell lung cancer with ALK rearrangement"}]},"trialDetails":[{"nctId":"NCT06317649","phase":"PHASE2","title":"Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2024-09-27","conditions":"Acute Myeloid Leukemia","enrollment":147},{"nctId":"NCT05564390","phase":"PHASE2","title":"MYELOMATCH: A Screening Study to Assign People With Myeloid Cancer to a Treatment Study or Standard of Care Treatment Within myeloMATCH (MyeloMATCH Screening Trial)","status":"RECRUITING","sponsor":"National Cancer Institute (NCI)","startDate":"2024-06-18","conditions":"Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm, Acute Myeloid Leukemia Post Cytotoxic Therapy","enrollment":2000},{"nctId":"NCT05756777","phase":"PHASE1","title":"A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)","status":"RECRUITING","sponsor":"Memorial Sloan Kettering Cancer Center","startDate":"2023-06-26","conditions":"Acute Myeloid Leukemia (AML)","enrollment":18},{"nctId":"NCT07407140","phase":"PHASE3","title":"VAG Versus Standard Chemotherapy With FLT3 Inhibitor in Adult Patients With FLT3-Mutated AML","status":"NOT_YET_RECRUITING","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2026-04-30","conditions":"AML, Adult","enrollment":300},{"nctId":"NCT04988555","phase":"PHASE1, PHASE2","title":"A Phase 1/2 Study of Enzomenib (DSP-5336) in Patients With Acute Leukemia (Horizen-1)","status":"RECRUITING","sponsor":"Sumitomo Pharma America, Inc.","startDate":"2022-02-28","conditions":"Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Acute, Multiple Myeloma","enrollment":606},{"nctId":"NCT07463651","phase":"PHASE3","title":"MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib","status":"RECRUITING","sponsor":"The First Affiliated Hospital of Soochow University","startDate":"2026-05-01","conditions":"Acute Myeloid Leukemia (AML), FLT3-ITD Mutation, Allogeneic Hematopoietic Cell Transplantation (HCT)","enrollment":594},{"nctId":"NCT03922100","phase":"PHASE1, PHASE2","title":"Study of NMS-03592088 in Patients With Relapsed or Refractory AML or CMML","status":"TERMINATED","sponsor":"Nerviano Medical Sciences","startDate":"2019-04-03","conditions":"Acute Myeloid Leukemia (AML), Chronic Myelomonocytic Leukemia (CMML)","enrollment":63},{"nctId":"NCT06222580","phase":"PHASE1","title":"SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation","status":"RECRUITING","sponsor":"Uma Borate","startDate":"2024-02-20","conditions":"Acute Myeloid Leukemia With FLT3/ITD Mutation, Acute Myeloid Leukemia With KMT2A Rearrangement, Acute Myeloid Leukemia With NPM1 Mutation","enrollment":30},{"nctId":"NCT06713837","phase":"PHASE3","title":"IMPACT-AML: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.","status":"RECRUITING","sponsor":"Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS","startDate":"2025-02-27","conditions":"Acute Myeloid Leukemia, Relapse/Recurrence","enrollment":339},{"nctId":"NCT07140016","phase":"PHASE1","title":"A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)","status":"RECRUITING","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2025-09-22","conditions":"Non-small Cell Lung Cancer (NSCLC), Anaplastic Lymphoma Kinase (ALK) Positive","enrollment":40},{"nctId":"NCT05520567","phase":"PHASE1, PHASE2","title":"A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2023-01-31","conditions":"Acute Myeloid Leukemia (AML), FLT3-mutated Acute Myeloid Leukemia","enrollment":70},{"nctId":"NCT04293562","phase":"PHASE3","title":"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","status":"RECRUITING","sponsor":"Children's Oncology Group","startDate":"2020-07-21","conditions":"Acute Myeloid Leukemia","enrollment":1186},{"nctId":"NCT07425808","phase":"PHASE2, PHASE3","title":"FLT3-ITD Targeted Therapy in Fit AML Patients","status":"NOT_YET_RECRUITING","sponsor":"European Organisation for Research and Treatment of Cancer - EORTC","startDate":"2026-12-01","conditions":"AML (Acute Myeloid Leukemia)","enrollment":230},{"nctId":"NCT05010122","phase":"PHASE1, PHASE2","title":"ASTX727, Venetoclax, and Gilteritinib for the Treatment of Newly Diagnosed, Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2021-07-08","conditions":"Acute Myeloid Leukemia, Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia","enrollment":42},{"nctId":"NCT03182244","phase":"PHASE3","title":"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","status":"ACTIVE_NOT_RECRUITING","sponsor":"Astellas Pharma Inc","startDate":"2017-10-25","conditions":"AML With FLT3 Mutation","enrollment":276},{"nctId":"NCT07259707","phase":"PHASE2","title":"Gilteritinib Plus VA Followed By Consolidation Chemotherapy in Newly Diagnosed FLT3-ITD+ AML","status":"RECRUITING","sponsor":"First Affiliated Hospital of Zhejiang University","startDate":"2026-01-25","conditions":"Acute Myeloid Leukemia, FLT3 Internal Tandem Duplication Positive, Intermediate Risk Acute Myeloid Leukemia","enrollment":25},{"nctId":"NCT05010772","phase":"PHASE1","title":"Decitabine Alone or in Combination With Venetoclax, Gilteritinib, Enasidenib, or Ivosidenib as Maintenance Therapy for the Treatment of Acute Myeloid Leukemia in Remission","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2021-10-25","conditions":"Acute Myeloid Leukemia","enrollment":125},{"nctId":"NCT05199051","phase":"PHASE2","title":"A Phase 2 Study of Gemtuzumab Ozogamicin (GO)-Gilteritinib Combination in Adults With FLT3-ITD and/or FLT3-TKD Relapse/Refractory (R/R) AML","status":"ACTIVE_NOT_RECRUITING","sponsor":"Centre Antoine Lacassagne","startDate":"2023-06-03","conditions":"AML, Leukaemia (Acute Myeloid)","enrollment":19},{"nctId":"NCT04240002","phase":"PHASE1, PHASE2","title":"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)","status":"TERMINATED","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2020-09-04","conditions":"Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase 3 (FLT3) Mutation / Internal Tandem Duplication (ITD)","enrollment":9},{"nctId":"NCT03013998","phase":"PHASE1, PHASE2","title":"Study of Biomarker-Based Treatment of Acute Myeloid Leukemia","status":"RECRUITING","sponsor":"Beat AML, LLC","startDate":"2016-11","conditions":"Previously Untreated Relapsed Refractory Acute Myeloid Leukemia","enrollment":3000},{"nctId":"NCT07032727","phase":"PHASE2","title":"Olutasidenib Combined With Co-targeted Therapy in Relapsed or Refractory IDH1-mutated Myeloid Malignancies Harboring Activated Signaling Pathway Mutations","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2025-09-12","conditions":"Targeted Therapy, IDH1-Mutated Malignancies, Mutations","enrollment":68},{"nctId":"NCT05955261","phase":"PHASE2","title":"A Study of Venetoclax in Combination With Conventional Chemotherapy in Pediatric Patients With Acute Myeloid Leukemia","status":"SUSPENDED","sponsor":"St. Jude Children's Research Hospital","startDate":"2023-07-25","conditions":"Acute Myeloid Leukemia","enrollment":70},{"nctId":"NCT04140487","phase":"PHASE1, PHASE2","title":"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","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2019-12-17","conditions":"Recurrent Acute Myeloid Leukemia, Recurrent Chronic Myelomonocytic Leukemia, Recurrent Myelodysplastic/Myeloproliferative Neoplasm","enrollment":97},{"nctId":"NCT05024552","phase":"PHASE1","title":"Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML","status":"RECRUITING","sponsor":"H. Lee Moffitt Cancer Center and Research Institute","startDate":"2022-02-25","conditions":"Acute Myeloid Leukemia With FLT3/ITD Mutation","enrollment":22},{"nctId":"NCT02421939","phase":"PHASE3","title":"A Study of ASP2215 Versus Salvage Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-like Tyrosine Kinase (FLT3) Mutation","status":"COMPLETED","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2015-10-20","conditions":"Leukemia, Acute Myeloid (AML)","enrollment":371},{"nctId":"NCT06001788","phase":"PHASE1","title":"Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia","status":"RECRUITING","sponsor":"Kura Oncology, Inc.","startDate":"2024-02-22","conditions":"AML, AML With Mutated NPM1, Hematologic Malignancy","enrollment":171},{"nctId":"NCT06235801","phase":"PHASE1, PHASE2","title":"A Phase I/II Study of Gilteritinib and Momelotinib for Patients With Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2024-05-22","conditions":"Myeloid Leukemia","enrollment":20},{"nctId":"NCT02115295","phase":"PHASE2","title":"Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia","status":"RECRUITING","sponsor":"M.D. Anderson Cancer Center","startDate":"2014-05-19","conditions":"Acute Biphenotypic Leukemia, Acute Myeloid Leukemia, Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive","enrollment":508},{"nctId":"NCT06225427","phase":"PHASE1","title":"Gilteritinib for the Treatment of ALK NSCLC","status":"RECRUITING","sponsor":"University of Michigan Rogel Cancer Center","startDate":"2024-07-25","conditions":"Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8","enrollment":30},{"nctId":"NCT04777916","phase":"","title":"Prospective Non-interventional Study of Adult Patients With Acute Myeloid Leukemia (AML)","status":"RECRUITING","sponsor":"Acute Leukemia French Association","startDate":"2022-04-14","conditions":"Acute Myeloid Leukemia (AML)","enrollment":5000},{"nctId":"NCT06561880","phase":"PHASE1, PHASE2","title":"The Efficacy of Triple Regimen in Newly Diagnosed AML Patients With FLT3 Mutation","status":"RECRUITING","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2024-10-08","conditions":"FLT3 Gene Mutation, AML","enrollment":36},{"nctId":"NCT02752035","phase":"PHASE3","title":"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","status":"COMPLETED","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2016-08-01","conditions":"Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation","enrollment":183},{"nctId":"NCT06734585","phase":"","title":"Using Gilteritinib to Keep People With Acute Myeloid Leukemia Cancer-free After a Stem Cell Transplant","status":"COMPLETED","sponsor":"Astellas Pharma Singapore Pte. Ltd.","startDate":"2025-01-09","conditions":"Acute Myeloid Leukemia","enrollment":114},{"nctId":"NCT02310321","phase":"PHASE1, PHASE2","title":"A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia.","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2015-02-26","conditions":"Acute Myeloid Leukemia, FLT3-mutated Acute Myeloid Leukemia","enrollment":97},{"nctId":"NCT07131059","phase":"NA","title":"MRD-positive AML Clinical Study","status":"RECRUITING","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2024-05-11","conditions":"AML, Adult","enrollment":120},{"nctId":"NCT07117422","phase":"NA","title":"Venetoclax-Decitabine in Untreated Elderly/Unfit AML","status":"RECRUITING","sponsor":"The Second Hospital of Hebei Medical University","startDate":"2025-01-17","conditions":"AML, Adult","enrollment":39},{"nctId":"NCT06265545","phase":"NA","title":"Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid Leukemia","status":"RECRUITING","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","startDate":"2024-02-22","conditions":"AML, Refractory, Relapsed","enrollment":120},{"nctId":"NCT06992934","phase":"NA","title":"Immunological Impact of a Post Cell Therapy Treatment With FLT3 Inhibitors","status":"NOT_YET_RECRUITING","sponsor":"Centre Hospitalier Universitaire de Nice","startDate":"2025-08","conditions":"Hematological Malignancies","enrollment":10},{"nctId":"NCT03680677","phase":"","title":"Frailty Phenotype Assessments to Optimize Treatment Strategies for Older Patients With Hematologic Malignancies","status":"RECRUITING","sponsor":"Abramson Cancer Center at Penn Medicine","startDate":"2018-09-21","conditions":"Leukemia, Acute, MDS","enrollment":20},{"nctId":"NCT03836209","phase":"PHASE2","title":"Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia","status":"ACTIVE_NOT_RECRUITING","sponsor":"PrECOG, LLC.","startDate":"2019-12-06","conditions":"Acute Myeloid Leukemia","enrollment":181},{"nctId":"NCT04691648","phase":"","title":"A Study to Assess the Safety of Xospata in Patients With Relapsed or Refractory Acute Myeloid Leukemia (AML) With FMS-Like Tyrosine Kinase 3 (FLT3) Mutation","status":"COMPLETED","sponsor":"Astellas Pharma Korea, Inc.","startDate":"2022-06-17","conditions":"Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation","enrollment":33},{"nctId":"NCT06696183","phase":"PHASE2","title":"Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment","status":"RECRUITING","sponsor":"Technische Universität Dresden","startDate":"2025-04-25","conditions":"AML - Acute Myeloid Leukemia","enrollment":60},{"nctId":"NCT06022003","phase":"PHASE2","title":"Study Investigating the Efficacy and Safety of the Addition of Oral-azacitidine to Salvage Treatment by Gilteritinib in Subjects ≥18 Years of Age With Relapsed/Refractory FLT3-mutated Acute Myeloid Leukemia","status":"RECRUITING","sponsor":"French Innovative Leukemia Organisation","startDate":"2024-01-13","conditions":"AML, Adult, Refractory AML, Relapsed Adult AML","enrollment":33},{"nctId":"NCT06667973","phase":"PHASE2","title":"Efficacy of Gilteritinib in Combination With FLAI as Induction Therapy of FLT3-positive Acute Myeloid Leukemia","status":"NOT_YET_RECRUITING","sponsor":"Gruppo Italiano Malattie EMatologiche dell'Adulto","startDate":"2025-06","conditions":"Acute Myeloid Leukemia, FLT3 Gene Mutation, Adult AML","enrollment":80},{"nctId":"NCT04477291","phase":"PHASE1","title":"A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS","status":"TERMINATED","sponsor":"Aptose Biosciences Inc.","startDate":"2020-10-06","conditions":"Acute Myeloid Leukemia, Myelodysplastic Syndromes","enrollment":45},{"nctId":"NCT02997202","phase":"PHASE3","title":"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)","status":"COMPLETED","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2017-08-16","conditions":"Acute Myeloid Leukemia","enrollment":356},{"nctId":"NCT06763666","phase":"PHASE4","title":"CLAG+VEN vs CLAG in the Treatment of Relapsed/Refractory AML","status":"NOT_YET_RECRUITING","sponsor":"Nanfang Hospital, Southern Medical University","startDate":"2025-02","conditions":"Relapsed/Refractory AML","enrollment":172},{"nctId":"NCT04027309","phase":"PHASE3","title":"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","status":"ACTIVE_NOT_RECRUITING","sponsor":"Stichting Hemato-Oncologie voor Volwassenen Nederland","startDate":"2019-12-20","conditions":"Acute Myeloid Leukemia, Myelodysplastic Syndrome With Excess Blasts-2","enrollment":777},{"nctId":"NCT02014558","phase":"PHASE1, PHASE2","title":"Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia","status":"COMPLETED","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2013-10-09","conditions":"Acute Myeloid Leukemia","enrollment":265},{"nctId":"NCT03730012","phase":"PHASE1, PHASE2","title":"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)","status":"COMPLETED","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2019-06-19","conditions":"Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation","enrollment":11},{"nctId":"NCT02495233","phase":"PHASE1, PHASE2","title":"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)","status":"TERMINATED","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2015-09-08","conditions":"Non-Small-Cell Lung Cancer","enrollment":10},{"nctId":"NCT02927262","phase":"PHASE2","title":"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","status":"COMPLETED","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2017-01-10","conditions":"Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation","enrollment":98},{"nctId":"NCT02561455","phase":"PHASE1, PHASE2","title":"Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial","status":"COMPLETED","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2016-05-03","conditions":"Advanced Solid Tumors, Acute Myeloid Leukemia","enrollment":9},{"nctId":"NCT02181660","phase":"PHASE1","title":"Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of ASP2215 in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia","status":"COMPLETED","sponsor":"Astellas Pharma Inc","startDate":"2014-06-16","conditions":"Acute Myeloid Leukemia (AML)","enrollment":24},{"nctId":"NCT02236013","phase":"PHASE1","title":"A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia","status":"COMPLETED","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2015-01-07","conditions":"Acute Myeloid Leukemia","enrollment":80},{"nctId":"NCT04699877","phase":"PHASE1","title":"A Study to Investigate the Effect of Severe Renal Impairment on Gilteritinib Compared to Healthy Participants With Normal Renal Function","status":"COMPLETED","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2021-01-28","conditions":"Renal Impaired, Gilteritinib, Normal Renal Function","enrollment":17},{"nctId":"NCT02571816","phase":"PHASE1","title":"A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP2215","status":"COMPLETED","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2015-10-23","conditions":"Hepatic Impairment, Healthy","enrollment":24},{"nctId":"NCT02456883","phase":"PHASE1","title":"Study to Investigate the Absorption, Metabolism and Excretion of [14C] ASP2215 in Patients With Advanced Solid Tumors","status":"COMPLETED","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2016-03-04","conditions":"Advanced Solid Tumors, Pharmacokinetics of 14C-labeled Gilteritinib","enrollment":6},{"nctId":"NCT06652685","phase":"PHASE2","title":"Molecular Subtype Combined with Early Minimal Residual Disease to Optimize the Treatment of Newly Diagnosed Acute Myeloid Leukemia","status":"NOT_YET_RECRUITING","sponsor":"Ruijin Hospital","startDate":"2024-10-30","conditions":"Acute Myeloid Leukemia (AML)","enrollment":218},{"nctId":"NCT03964038","phase":"PHASE1","title":"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","status":"COMPLETED","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"2019-05-21","conditions":"Healthy Volunteer","enrollment":48},{"nctId":"NCT05177731","phase":"PHASE3","title":"Venetoclax + Decitabine vs. \"7+3\" Induction Chemotherapy in Young AML","status":"ACTIVE_NOT_RECRUITING","sponsor":"Chen Suning","startDate":"2022-03-01","conditions":"AML, Adult, Chemotherapy Effect","enrollment":188},{"nctId":"NCT06221683","phase":"PHASE2","title":"Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML","status":"RECRUITING","sponsor":"Children's Hospital of Soochow University","startDate":"2024-01-01","conditions":"AML, Childhood, Acute Myeloid Leukemia","enrollment":500},{"nctId":"NCT05028751","phase":"PHASE1, PHASE2","title":"A Study to Evaluate Lanraplenib (LANRA) in Combination With Gilteritinib in Participants With FLT3-mutated Relapsed or Refractory Acute Myeloid Leukemia (AML)","status":"TERMINATED","sponsor":"Kronos Bio","startDate":"2022-08-05","conditions":"Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia","enrollment":24},{"nctId":"NCT05546580","phase":"PHASE1","title":"Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)","status":"RECRUITING","sponsor":"Oryzon Genomics S.A.","startDate":"2022-11-14","conditions":"Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory","enrollment":50},{"nctId":"NCT04336982","phase":"PHASE1","title":"A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia","status":"TERMINATED","sponsor":"Celgene","startDate":"2020-08-05","conditions":"Leukemia, Myeloid, Acute","enrollment":22},{"nctId":"NCT03315299","phase":"","title":"Individual Patient Expanded Access Gilteritinib (ASP2215)","status":"NO_LONGER_AVAILABLE","sponsor":"Etan Orgel","startDate":"","conditions":"AML","enrollment":""},{"nctId":"NCT05193448","phase":"","title":"A Non-interventional Ambispective Real-world Cohort of rEfractory and reLapsed (R/R) FLT3 Mutated Acute MyEloid Leukemia (AML) Patients Treated With Gilteritinib in FrANCE","status":"COMPLETED","sponsor":"French Innovative Leukemia Organisation","startDate":"2021-07-05","conditions":"Refractory AML, Relapsed Adult AML, FLT3-TKD Mutation","enrollment":177},{"nctId":"NCT05330377","phase":"PHASE1","title":"GM-CLAG in Relapsed/Refractory FLT3-mutated AML","status":"WITHDRAWN","sponsor":"Ayman H Qasrawi","startDate":"2023-03","conditions":"Acute Myeloid Leukemia","enrollment":""},{"nctId":"NCT05791890","phase":"","title":"GilteRInf 2022 Study (Gilteritinib Related Infections)","status":"UNKNOWN","sponsor":"University of Rome Tor Vergata","startDate":"2022-05-31","conditions":"Acute Myeloid Leukemia","enrollment":78},{"nctId":"NCT05312112","phase":"","title":"Real World Outcomes Using Novel Agents for AML in the UK","status":"UNKNOWN","sponsor":"Guy's and St Thomas' NHS Foundation Trust","startDate":"2022-05-01","conditions":"Acute Myeloid Leukemia","enrollment":1000},{"nctId":"NCT05279859","phase":"PHASE1, PHASE2","title":"A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Hematologic Malignancies","status":"WITHDRAWN","sponsor":"Erasca, Inc.","startDate":"2022-03-15","conditions":"Acute Myeloid Leukemia","enrollment":""},{"nctId":"NCT04655391","phase":"PHASE1","title":"Glasdegib-Based Treatment Combinations for the Treatment of Patients With Relapsed Acute Myeloid Leukemia Who Have Undergone Hematopoietic Cell Transplantation","status":"WITHDRAWN","sponsor":"City of Hope Medical Center","startDate":"2022-06-25","conditions":"Recurrent Acute Myeloid Leukemia","enrollment":""},{"nctId":"NCT03625505","phase":"PHASE1","title":"A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia","status":"COMPLETED","sponsor":"AbbVie","startDate":"2018-10-18","conditions":"Acute Myeloid Leukemia (AML)","enrollment":61},{"nctId":"NCT03070093","phase":"","title":"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)","status":"APPROVED_FOR_MARKETING","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"","conditions":"Acute Myeloid Leukemia (AML), FMS-like Tyrosine Kinase-3 (FLT3) Mutations","enrollment":""},{"nctId":"NCT02622932","phase":"PHASE1","title":"Study to Investigate the Absorption, Metabolism and Excretion of [14C] Anlotinib in Patients With Advanced Cancer Patients","status":"COMPLETED","sponsor":"Chia Tai Tianqing Pharmaceutical Group Co., Ltd.","startDate":"2015-12-02","conditions":"Advanced Solid Tumors","enrollment":6},{"nctId":"NCT03409081","phase":"","title":"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)","status":"NO_LONGER_AVAILABLE","sponsor":"Astellas Pharma Global Development, Inc.","startDate":"","conditions":"Acute Myeloid Leukemia (AML), FMS-like Tyrosine Kinase-3 (FLT3) Mutations","enrollment":""}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["gilteritinib"],"phase":"phase_2","status":"active","brandName":"ASP2215","genericName":"ASP2215","companyName":"Astellas Pharma Global Development, Inc.","companyId":"astellas-pharma-global-development-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"ASP2215 is a selective and potent inhibitor of the anaplastic lymphoma kinase (ALK) receptor tyrosine kinase. Used for Non-small cell lung cancer with ALK rearrangement, Ceritinib-resistant non-small cell lung cancer with ALK rearrangement.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":2,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}