Clinical trials: Gilteritinib
AML With FLT3 Mutation
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
The purpose of this study was to determine the clinical benefit of ASP2215 therapy in participants with FMS-like tyrosine kinase (FLT3) mutated AML who were refractory to or had relapse after first-line AML therapy as shown with…
- Trial name
- NCT03182244
- Testing
- Gilteritinib, Cytarabine, Mitoxantrone
- Where
- 49 sites in China, Malaysia and 3 more
- Volunteers
- 276 people
- Sponsor
- Astellas Pharma 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
A Study of Anti-Cancer Therapies Targeting the MAPK Pathway in Patients With Hematologic Malignancies
To evaluate the safety and tolerability of escalating doses of ERAS-007 or ERAS-601 in combination with other cancer therapies in study participants with hematologic malignancies.
- Trial name
- HERKULES-4 (NCT05279859)
- Testing
- ERAS-007, ERAS-601, Gilteritinib
- Where
- 4 sites in United States
- Sponsor
- Erasca, Inc.
Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia
A Study to Evaluate Lanraplenib (LANRA) in Combination With Gilteritinib in Participants With FLT3-mutated Relapsed or Refractory Acute Myeloid Leukemia (AML)
The primary objective of this study is to evaluate the safety of lanraplenib (LANRA) in combination with the FMS-like tyrosine kinase 3 (FLT3) inhibitor gilteritinib, in participants with relapsed or refractory (R/R) FLT3-mutated…
- Conditions
- Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
- Trial name
- NCT05028751
- Testing
- Lanraplenib, Gilteritinib
- Where
- 17 sites in United States, Spain
- Volunteers
- 24 people
- Sponsor
- Kronos Bio
Acute Myeloid Leukemia, FLT3-mutated Acute Myeloid Leukemia
A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia.
The purpose of phase 1 part in this study was to determine the maximum tolerated dose (MTD) and/or recommended expansion dose (RED) of ASP2215 concomitant with cytarabine/idarubicin as induction chemotherapy based on the status…
- Trial name
- NCT02310321
- Testing
- Gilteritinib, Idarubicin, Cytarabine
- Where
- 55 sites in Japan, South Korea and 1 more
- Volunteers
- 97 people
- Sponsor
- Astellas Pharma Inc
Healthy Volunteer
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
The purpose of this study is to assess the relative bioavailability as well as the safety and tolerability of single doses of gilteritinib mini-tablets oral suspension and gilteritinib mini tablets compared to gilteritinib…
- Trial name
- NCT03964038
- Testing
- gilteritinib, gilteritinib mini tablet
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia, Myelodysplastic Syndromes
A Study of CG-806 in Patients With Relapsed or Refractory AML or Higher-Risk MDS
This study is being done to evaluate the safety, tolerability and antitumor activity of oral CG-806 (luxeptinib) for the treatment of patients with Acute Myeloid Leukemia (except APML), secondary AML, therapy-related AML, or…
- Trial name
- NCT04477291
- Testing
- CG-806
- Where
- 10 sites in United States
- Volunteers
- 45 people
- Sponsor
- Aptose Biosciences Inc.
Acute Myeloid Leukemia
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)
The purpose of this study was to compare relapse-free survival between participants with FLT3/ITD AML in first morphologic complete remission (CR1) who underwent hematopoietic stem cell transplant (HCT) and were randomized to…
- Trial name
- NCT02997202
- Testing
- gilteritinib
- Where
- 118 sites in United States, Australia and 14 more
- Volunteers
- 356 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia Refractory
Study of Iadademstat and Gilteritinib in Patients With R/R AML With FMS-like Tyrosine Kinase Mutation (FLT3 Mut+)
Iadademstat is being studied as a treatment for subjects with Relapsed or Refractory Acute Myeloid Leukemia (R/R AML) with FMS-like tyrosine kinase mutation (FLT3 mut+).
- Trial name
- FRIDA (NCT05546580)
- Testing
- Iadademstat, Gilteritinib Oral Tablet
- Where
- 13 sites in United States
- Volunteers
- 50 people
- Sponsor
- Oryzon Genomics S.A.
Advanced Solid Tumors, Pharmacokinetics of 14C-labeled Gilteritinib
Study to Investigate the Absorption, Metabolism and Excretion of [14C] ASP2215 in Patients With Advanced Solid Tumors
The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled gilteritinib, in particular, the routes of excretion and extent of metabolism of gilteritinib following administration of a single dose of 14C-labeled…
- Trial name
- NCT02456883
- Testing
- gilteritinib, 14C-labeled gilteritinib
- Where
- United States
- Volunteers
- 6 people
- 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
A Study of ASP2215 in Combination With Induction and Consolidation Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia
The purpose of this study is to describe the dose limiting toxicities (DLT) and define the maximum tolerated dose (MTD) of ASP2215 when combined with cytarabine/idarubicin or daunorubicin remission induction in a 7+3 schedule.
- Trial name
- NCT02236013
- Testing
- Gilteritinib, Idarubicin, Cytarabine
- Where
- 10 sites in United States
- Volunteers
- 80 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
Acute Myeloid Leukemia (AML), FMS-like Tyrosine Kinase-3 (FLT3) Mutations
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)
The purpose of this study is to provide expanded access to gilteritinib (ASP2215) for patients with FMS-like tyrosine kinase 3 (FLT3)-mutated relapsed or refractory acute myeloid leukemia (AML) or with FLT3-mutated AML in…
- Trial name
- NCT03409081
- Testing
- gilteritinib
- Where
- 6 sites in Australia, Italy and 1 more
- Sponsor
- Astellas Pharma Global Development, Inc.
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.
Hepatic Impairment, Healthy
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP2215
The purpose of this study is to compare the single-dose pharmacokinetics of ASP2215 in subjects with mild and moderate hepatic impairment to matched healthy subjects with normal hepatic function.
- Trial name
- NCT02571816
- Testing
- ASP2215
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia
Dose Escalation Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of ASP2215 in Patients With Relapsed or Refractory Acute Myeloid Leukemia
The objective of this study was to assess the safety and tolerability, including the maximum tolerated dose, of gilteritinib in participants with relapsed or treatment-refractory acute myeloid leukemia (AML).
- Trial name
- NCT02014558
- Testing
- Gilteritinib, Voriconazole, Midazolam
- Where
- 26 sites in United States, Germany and 1 more
- Volunteers
- 265 people
- Sponsor
- Astellas Pharma Global Development, Inc.
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
Using Gilteritinib to Keep People With Acute Myeloid Leukemia Cancer-free After a Stem Cell Transplant
People with acute myeloid leukemia (AML) are usually treated with chemotherapy. When the cancer comes back (relapse) the next treatment is usually a stem cell transplant.
- Trial name
- NCT06734585
- Testing
- Gilteritinib
- Where
- 18 sites in Australia, Brazil and 4 more
- Volunteers
- 114 people
- Sponsor
- Astellas Pharma Singapore Pte. Ltd.
Acute Myeloid Leukemia (AML), FMS-like Tyrosine Kinase-3 (FLT3) Mutations
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)
The purpose of this study is to provide expanded access to ASP2215 for subjects with FLT3-mutated relapsed or refractory AML or FLT3-mutated AML in composite complete remission (CRc) (complete remission [CR], complete remission…
- Trial name
- NCT03070093
- Testing
- gilteritinib
- Where
- 39 sites in United States, Canada and 1 more
- Sponsor
- Astellas Pharma Global Development, Inc.