Quizartinib

Generic Name
Quizartinib
Brand Names
Vanflyta
Drug Type
Small Molecule
Chemical Formula
C29H32N6O4S
CAS Number
950769-58-1
Unique Ingredient Identifier
7LA4O6Q0D3
Background

Quizartinib is an oral and potent fms-like tyrosine kinase 3 (FLT3) inhibitor and it is the first drug developed specifically targeting FLT3, as other agents with FLT3 inhibition activities were investigated with other targets in mind. Additionally, quizartinib also demonstrates inhibitory activity toward FLT3 with internal tandem duplication (ITD), although...

Indication

Quizartinib is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-appr...

Associated Conditions
Newly Diagnosed Acute Myeloid Leukemia (AML)
Associated Therapies
-

Study to Assess the Effect of a CYP3A Weak Inducer Rufinamide on Quizartinib Pharmacokinetics in Healthy Subjects

Phase 1
Completed
Conditions
Interventions
First Posted Date
2024-12-18
Last Posted Date
2024-12-18
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
32
Registration Number
NCT06740825
Locations
🇺🇸

WCT, San Antonio, Texas, United States

Assessment of Quizartinib Pharmacokinetic in Subjects With Severe Hepatic Impairment

Phase 1
Recruiting
Conditions
Interventions
First Posted Date
2024-12-18
Last Posted Date
2024-12-18
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
12
Registration Number
NCT06740799
Locations
🇺🇸

Clinical Pharmacology of Miami, LLC, Miami, Florida, United States

🇺🇸

Advanced Pharma, Miami, Florida, United States

🇺🇸

GCP Research, Saint Petersburg, Florida, United States

Quizartinib or Placebo Plus Chemotherapy in Newly Diagnosed Patients With FLT3-ITD Negative AML

Phase 3
Recruiting
Conditions
Interventions
First Posted Date
2024-08-29
Last Posted Date
2024-12-05
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
700
Registration Number
NCT06578247
Locations
🇺🇸

City of Hope Phoenix, Goodyear, Arizona, United States

🇺🇸

Mayo Clinic - Phoenix, Phoenix, Arizona, United States

🇺🇸

University of Arizona Cancer Center, Tucson, Arizona, United States

and more 97 locations

CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients

First Posted Date
2024-02-16
Last Posted Date
2024-02-16
Lead Sponsor
Princess Maxima Center for Pediatric Oncology
Target Recruit Count
60
Registration Number
NCT06262438
Locations
🇳🇱

Princess Máxima Center for pediatric oncology, Utrecht, Netherlands

Clinical Trial to Assess the Safety and Tolerability of the Combination of Low-dose Cytarabine or Azacitidine Plus Venetoclax and Quizartinib in Newly Diagnosed AML Patients Aged Equal or More Than 60 Years Old

First Posted Date
2020-12-29
Last Posted Date
2022-09-08
Lead Sponsor
PETHEMA Foundation
Target Recruit Count
84
Registration Number
NCT04687761
Locations
🇪🇸

Hospital Universitario Príncipe de Asturias, Alcalá De Henares, Spain

🇪🇸

Hospital Clínic, Barcelona, Spain

🇪🇸

Hospital Universitari Arnau de Vilanova de Lleida, Lleida, Spain

and more 12 locations

A Study of Quizartinib Pharmacokinetics in Participants With Moderate Hepatic Impairment

First Posted Date
2020-07-16
Last Posted Date
2023-08-01
Lead Sponsor
Daiichi Sankyo
Target Recruit Count
12
Registration Number
NCT04473664
Locations
🇺🇸

Clinical Pharmacology of Miami, LLC, Miami, Florida, United States

🇺🇸

Orlando Clinical Research Center, Orlando, Florida, United States

🇺🇸

Advanced Pharma, Miami, Florida, United States

A Study of the Effect of a Moderate CYP3A Inducer Efavirenz on Quizartinib Pharmacokinetics in Healthy Participants

First Posted Date
2020-07-07
Last Posted Date
2022-06-28
Lead Sponsor
Daiichi Sankyo Co., Ltd.
Target Recruit Count
32
Registration Number
NCT04459598
Locations
🇺🇸

Worldwide Clinical Trials, San Antonio, Texas, United States

A Study of the Effect of Quizartinib on the Pharmacokinetics of the P-gp Substrate Dabigatran Etexilate in Healthy Participants

First Posted Date
2020-07-07
Last Posted Date
2021-07-09
Lead Sponsor
Daiichi Sankyo Co., Ltd.
Target Recruit Count
20
Registration Number
NCT04459585
Locations
🇺🇸

Worldwide Clinical Trials, San Antonio, Texas, United States

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