Clinical trials: Gilteritinib
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
Non-Small-Cell Lung Cancer
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)
The purpose of the Phase 1b part of the study was to evaluate the safety and tolerability of ASP2215 in combination with erlotinib and determine the recommended phase 2 dose (RP2D) of ASP2215.
- Trial name
- NCT02495233
- Testing
- Gilteritinib, Erlotinib
- Where
- 4 sites in Japan
- Volunteers
- 10 people
- Sponsor
- Astellas Pharma Global Development, 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, 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.
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
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 (AML), FLT3-mutated Acute Myeloid Leukemia
A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia
People with acute myeloid leukemia (AML) are usually treated with chemotherapy. Some people with AML have a changed FLT3 gene which causes leukemia cells to grow faster.
- Trial name
- NCT05520567
- Testing
- Gilteritinib, Venetoclax, Azacitidine
- Where
- 18 sites in United States
- Volunteers
- 70 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 (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