Clinical trials: Gilteritinib
Advanced Solid Tumors, Acute Myeloid Leukemia
Rollover Study for Subjects Who Have Participated in an Astellas Sponsored ASP2215 Trial
The purpose of the study was to provide access to continued treatment for those who participated in other Astellas sponsored ASP2215 trials that completed the primary analysis and, had the potential to continue to derive clinical…
- Trial name
- NCT02561455
- Testing
- Gilteritinib
- Where
- 7 sites in United States
- Volunteers
- 9 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Leukemia, Myeloid, Acute
A Safety and Efficacy Study of CC-90009 Combinations in Subjects With Acute Myeloid Leukemia
CC-90009-AML-002 is an exploratory Phase 1b, open-label, multi-arm trial to evaluate the safety and efficacy of CC-90009 in combination with anti-leukemia agents in participants with acute myeloid leukemia (AML).
- Trial name
- NCT04336982
- Testing
- CC-90009, Venetoclax, Azacitidine
- Where
- 14 sites in United States, Belgium and 3 more
- Volunteers
- 22 people
- Sponsor
- Celgene
Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) Mutation
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
The objective of this study is to describe the observed safety profile of Xospata® 40 mg tablet when administered in patients with relapsed or refractory AML with FLT3 mutation in routine clinical practice in Korea.
- Trial name
- NCT04691648
- Testing
- Gilteritinib Exposure
- Where
- 10 sites in South Korea
- Volunteers
- 33 people
- Sponsor
- Astellas Pharma Korea, Inc.
Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase (FLT3) / Internal Tandem Duplication (ITD) Mutation
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
The purpose of this study was to compare relapse-free survival (RFS) between participants with FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) acute myeloid leukemia (AML) in first complete remission (CR1)…
- Trial name
- NCT02927262
- Testing
- Gilteritinib
- Where
- 73 sites in United States, Brazil and 19 more
- Volunteers
- 98 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia (AML)
A Study to Assess Safety and Efficacy of Venetoclax in Combination With Gilteritinib in Participants With Relapsed/Refractory Acute Myeloid Leukemia
A dose-escalation study evaluating the safety, tolerability, pharmacokinetics (PK) and efficacy of venetoclax, in combination with gilteritinib, in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML) who…
- Trial name
- NCT03625505
- Testing
- Venetoclax, Gilteritinib
- Where
- 11 sites in United States
- Volunteers
- 61 people
- Sponsor
- AbbVie
AML - Acute Myeloid Leukemia
Gilteritinib in Combination With Venetoclax and Azacitidine for AML Patients With FLT3 Mutations Ineligible for Intensive Treatment
Explore the best tolerable and efficacious dose of Gilteritinib when combined with standard treatment with Venetoclax and Azacitidine in AML patients with FLT3 mutations which are ineligible for intensive chemotherapy
- Trial name
- SEQUENCE (NCT06696183)
- Testing
- Gilteritinib (GILT), Venetoclax (VEN), Azacitidine (AZA)
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Technische Universität Dresden
Acute Myeloid Leukemia, FLT3 Gene Mutation
Efficacy of Gilteritinib in Combination With FLAI as Induction Therapy of FLT3-positive Acute Myeloid Leukemia
The goal of this clinical trial is to evaluate the efficacy of gilteritinib as induction therapy in FLT3-positive adult acute myeloid leukemia patients.
- Conditions
- Acute Myeloid Leukemia, FLT3 Gene Mutation, Adult AML, Diagnosis
- Trial name
- NCT06667973
- Testing
- Gilteritinib
- Volunteers
- 80 people
- Sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
Acute Myeloid Leukemia
GilteRInf 2022 Study (Gilteritinib Related Infections)
The study is observational, retrospective-prospective, multicenter "real-life" study involving 26 centers belonging to the SEIFEM group.
- Trial name
- GilteRInf (NCT05791890)
- Testing
- Gilteritinib
- Where
- Italy
- Volunteers
- 78 people
- Sponsor
- University of Rome Tor Vergata
Acute Myeloid Leukemia (AML)
Molecular Subtype Combined with Early Minimal Residual Disease to Optimize the Treatment of Newly Diagnosed Acute Myeloid Leukemia
This study aims to investigate the safety and efficacy of drug "X" in combination with intensive chemotherapy in subjects with newly diagnosed AML (excluding APL and CBF-AML).
- Trial name
- NCT06652685
- Testing
- D5-PBCR(-) IA arm, D5-PBCR(+) IA+Venetoclax arm
- Where
- China
- Volunteers
- 218 people
- Sponsor
- Ruijin Hospital
Non-small Cell Lung Cancer (NSCLC), Anaplastic Lymphoma Kinase (ALK) Positive
A Study of Gilteritinib in Adults With Advanced ALK-positive Non-small Cell Lung Cancer (NSCLC)
Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty.
- Trial name
- NCT07140016
- Testing
- gilteritinib
- Where
- 17 sites in United States, France and 1 more
- Volunteers
- 40 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia With FLT3/ITD Mutation
Vyxeos Plus Gilteritinib in Relapsed or Refractory, FLT3-Mutated AML
This study combines vyxeos and gilteritinib in patients with relapsed or refractory FLT3-mutated acute myeloid leukemia. Vyxeos and gilteritinib will be given as induction therapy.
- Trial name
- NCT05024552
- Testing
- Gilteritinib, Vyxeos
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Renal Impaired, Gilteritinib
A Study to Investigate the Effect of Severe Renal Impairment on Gilteritinib Compared to Healthy Participants With Normal Renal Function
The purpose of the study was to evaluate the pharmacokinetics of a single oral dose of gilteritinib in male and female participants with severe renal impairment compared to healthy male and female participants with normal renal…
- Conditions
- Renal Impaired, Gilteritinib, Normal Renal Function, Pharmacokinetics of ASP2215
- Trial name
- NCT04699877
- Testing
- Gilteritinib
- Where
- 4 sites in United States, Bulgaria
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia (AML)
Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of ASP2215 in Japanese Patients With Relapsed or Refractory Acute Myeloid Leukemia
The objectives of this study are to determine the safety and tolerability of ASP2215 as well as the maximum tolerated dose (MTD) based on the onset of dose limiting toxicity (DLT) and/or determine the recommended dose (RD) of…
- Trial name
- NCT02181660
- Testing
- Gilteritinib
- Where
- 5 sites in Japan
- Volunteers
- 24 people
- Sponsor
- Astellas Pharma Inc
Acute Myeloid Leukemia (AML)
A Study of Gilteritinib in Combination With Ivosidenib or Enasidenib in People With Acute Myeloid Leukemia (AML)
The researchers are doing this study to see if the combination of gilteritinib with ivosidenib or enasidenib is a safe and effective treatment for people with relapsed/refractory AML with FLT3/IDH1 or FLT3/IDH2 gene mutations.
- Trial name
- NCT05756777
- Testing
- Gilteritinib, Ivosidenib, Enasidenib
- Where
- 7 sites in United States
- Volunteers
- 8 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
Gilteritinib for the Treatment of ALK NSCLC
This phase I trial is studying the safety, side effects, and best dose of gilteritinib in treating patients with stage IV ALK positive non-small cell lung cancer (NSCLC) who have progressed on other treatments.
- Trial name
- NCT06225427
- Testing
- Biopsy, Biospecimen Collection, Computed Tomography
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- University of Michigan Rogel Cancer Center