Quizartinib

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Information
Drug Name
Quizartinib
Description
Entry(CIViC)
4
CIViC
Disease Mutation EL ET ED CS VO TR Pubmed Links
acute myeloid leukemia FLT3 p.Asp835Tyr (p.D835Y)
( ENST00000241453.12 ) FLT3 p.Asp835Tyr (p.D835Y)
( ENST00000241453.12 ) 		D Predictive Supports Resistance Somatic 3 23430109 Detail
acute myeloid leukemia FLT3 p.Asp835Tyr (p.D835Y)
( ENST00000241453.12 ) FLT3 p.Asp835Tyr (p.D835Y)
( ENST00000241453.12 ) 		B Predictive Supports Resistance Somatic 4 22504184 Detail
acute myeloid leukemia FGF2 EXPRESSION FGF2 EXPRESSION D Predictive Supports Resistance N/A 4 27671675 Detail
acute myeloid leukemia FLT3 p.Asp835Val (p.D835V)
( ENST00000241453.12 ) FLT3 p.Asp835Val (p.D835V)
( ENST00000241453.12 ) 		D Predictive Does Not Support Sensitivity/Response Somatic 5 23497317 Detail
Annotation
Description Associated Genes Associated Variants Sensitivity Supported Source Links
An in-vitro saturation mutagenesis screen of 50 in... FLT3 FLT3 p.Asp835Tyr (p.D835Y)
( ENST00000241453.12 ) FLT3 p.Asp835Tyr (p.D835Y)
( ENST00000241453.12 ) 		Resitance or Non-Reponse true CIViC Evidence detail
In an in-vitro study using an in vitro saturation ... FLT3 FLT3 p.Asp835Tyr (p.D835Y)
( ENST00000241453.12 ) FLT3 p.Asp835Tyr (p.D835Y)
( ENST00000241453.12 ) 		Resitance or Non-Reponse true CIViC Evidence detail
AML MOLM14 cells were cocultured with FLT3 inhibit... FGF2 FGF2 EXPRESSION FGF2 EXPRESSION Resitance or Non-Reponse true CIViC Evidence detail
Murine Ba/F3 cell line has a restrictive sensitivi... FLT3 FLT3 p.Asp835Val (p.D835V)
( ENST00000241453.12 ) FLT3 p.Asp835Val (p.D835V)
( ENST00000241453.12 ) 		Sensitivity false CIViC Evidence detail
NCT ID Status Phase Summary Start date Completion date
NCT04107727 Active, not recruiting Phase 2 Trial to Compare Efficacy and Safety of Chemotherapy/Quizartinib vs Chemotherapy/Placebo in Adults FMS-like Tyrosine Kinase 3 (FLT3) Wild-type Acute Myeloid Leukemia (AML) September 5, 2019 September 2024
NCT04459598 Completed Phase 1 A Study of the Effect of a Moderate CYP3A Inducer Efavirenz on Quizartinib Pharmacokinetics in Healthy Participants August 19, 2020 October 14, 2020
NCT02834390 Completed Phase 1 Study of Quizartinib in Japanese Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) August 12, 2016 October 19, 2017
NCT04459585 Completed Early Phase 1 A Study of the Effect of Quizartinib on the Pharmacokinetics of the P-gp Substrate Dabigatran Etexilate in Healthy Participants August 28, 2020 October 20, 2020
NCT02984995 Completed Phase 2 Phase 2 Study of Quizartinib in Participants With Acute Myeloid Leukemia (AML) FLT3 Internal Tandem Duplication (FLT3/ITD) Mutation December 8, 2016 September 14, 2018
NCT01576185 Completed Developing and Treating a Mouse Model of Acute Myeloid Leukemia Using Tissue Samples From Younger Patients With Acute Myeloid Leukemia May 2012 May 2016
NCT04473664 Completed Phase 1 A Study of Quizartinib Pharmacokinetics in Participants With Moderate Hepatic Impairment September 22, 2020 July 22, 2021
NCT01892371 Completed Phase 1/Phase 2 Quizartinib With Azacitidine or Cytarabine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome November 12, 2013 February 7, 2023
NCT03723681 Completed Phase 1 Study of Quizartinib in Combination With Standard Therapies in Chinese Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) November 5, 2018 March 3, 2022
NCT03735875 Completed Phase 1/Phase 2 Venetoclax and Quizartinib in Treating Patients With FLT3-mutated Recurrent or Refractory Acute Myeloid Leukemia January 25, 2019 July 26, 2023
NCT02668653 Completed Phase 3 Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML) September 1, 2016 June 16, 2023
NCT02039726 Completed Phase 3 (QuANTUM-R): An Open-label Study of Quizartinib Monotherapy vs. Salvage Chemotherapy in Acute Myeloid Leukemia (AML) Subjects Who Are FLT3-ITD Positive May 2014 September 8, 2020
NCT06262438 Recruiting Phase 2 CHIP-AML22/Quizartinib: Quizartinib + Chemotherapy in Newly Diagnosed Pediatric FLT3-ITD+ and NPM1wt AML Patients February 6, 2024 June 2032
NCT03661307 Recruiting Phase 1/Phase 2 Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome October 31, 2018 January 1, 2026
NCT03793478 Recruiting Phase 1/Phase 2 Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood August 15, 2018 May 1, 2027
NCT04047641 Recruiting Phase 1/Phase 2 Cladribine, Idarubicin, Cytarabine, and Quizartinib in Treating Patients With Newly Diagnosed, Relapsed, or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome October 22, 2019 December 31, 2025
NCT04128748 Recruiting Phase 1/Phase 2 Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome May 27, 2020 December 31, 2025
NCT04493138 Recruiting Phase 1/Phase 2 Azacitidine and Quizartinib for the Treatment of Myelodysplastic Syndrome or Myelodysplastic/Myeloproliferative Neoplasm With FLT3 or CBL Mutations July 21, 2020 December 31, 2025
NCT04687761 Recruiting Phase 1/Phase 2 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 November 4, 2020 November 2024
NCT03552029 Terminated Phase 1 Milademetan Plus Quizartinib Combination Study in FLT3-ITD Mutant Acute Myeloid Leukemia (AML) December 12, 2018 April 1, 2021
NCT04209725 Terminated Phase 2 A Study of CPX-351 (Vyxeos™) With Quizartinib for the Treatment of FLT3-ITD Mutation-Positive Acute Myeloid Leukemia June 3, 2020 April 20, 2021
NCT03135054 Unknown status Phase 2 Combination of Quizartinib and Omacetaxine Mepesuccinate for AML Carrying FLT3-ITD October 1, 2017 October 1, 2021
NCT04112589 Unknown status Phase 1/Phase 2 A Clinical Trial to Assess the Efficacy and Safety of the Combination of a Drug Call Quizartinib With Chemotherapy (FLAG-IDA) in Patients With Acute Myeloid Leukemia That Has Not Responded to the First Treatment or That Has Returned After the First Treatment December 26, 2019 December 2023
NCT04676243 Withdrawn Phase 3 Daunorubicin or Idarubicin With Cytarabine Plus Quizartinib vs Physician's Choice in Newly Diagnosed FLT3-ITD+ AML May 2022 December 2025