Infigratinib

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Information
Drug Name
Infigratinib
Description
Entry(CIViC)
15
CIViC
Disease Mutation EL ET ED CS VO TR Pubmed Links
cholangiocarcinoma FGFR2 FGFR2-BICC1 D Predictive Supports Sensitivity/Response Somatic 3 24122810 Detail
cholangiocarcinoma FGFR2 FGFR2-AHCYL1 D Predictive Supports Sensitivity/Response Somatic 3 24122810 Detail
lung squamous cell carcinoma FGFR1 AMPLIFICATION
( ENST00000425967.8 ) FGFR1 AMPLIFICATION
( ENST00000425967.8 )
B Predictive Supports Sensitivity/Response N/A 3 27870574 Detail
breast cancer FGFR1 AMPLIFICATION
( ENST00000425967.8 ) FGFR1 AMPLIFICATION
( ENST00000425967.8 )
B Predictive Does Not Support Sensitivity/Response 2 27870574 Detail
bladder carcinoma FGFR3 MUTATION FGFR3 MUTATION B Predictive Supports Sensitivity/Response Somatic 3 27870574 Detail
bladder carcinoma FGFR1 AMPLIFICATION
( ENST00000425967.8 ) FGFR1 AMPLIFICATION
( ENST00000425967.8 )
C Predictive Does Not Support Sensitivity/Response N/A 2 27870574 Detail
cholangiocarcinoma FGFR2 MUTATION FGFR2 MUTATION C Predictive Supports Sensitivity/Response Somatic 2 27870574 Detail
cholangiocarcinoma FGFR2 FUSION FGFR2 FUSION C Predictive Supports Sensitivity/Response Somatic 2 27870574 Detail
sarcoma FGFR1 EXPRESSION FGFR1 EXPRESSION D Predictive Supports Sensitivity/Response Somatic 3 27535980 Detail
cholangiocarcinoma FGFR2 FUSION FGFR2 FUSION B Predictive Supports Sensitivity/Response Somatic 4 29182496 Detail
cholangiocarcinoma FGFR2 FUSION FGFR2 FUSION B Predictive Supports Sensitivity/Response Somatic 4 29182496 Detail
transitional cell carcinoma FGFR3 FGFR3-TACC3 B Predictive Supports Sensitivity/Response 3 29848605 Detail
head and neck squamous cell carcinoma FGFR1 EXPRESSION FGFR1 EXPRESSION D Predictive Supports Sensitivity/Response N/A 3 26015511 Detail
gastric adenocarcinoma FGFR1 EXPRESSION FGFR1 EXPRESSION D Predictive Supports Sensitivity/Response N/A 2 26637881 Detail
colorectal cancer FGFR1 EXPRESSION FGFR1 EXPRESSION D Predictive Supports Sensitivity/Response N/A 2 24135816 Detail
Annotation
Description Associated Genes Associated Variants Sensitivity Supported Source Links
Expression of the FGFR2-BICC1 fusion kinase in NIH... FGFR2 FGFR2 FGFR2-BICC1 Sensitivity true CIViC Evidence detail
Expression of the FGFR2-AHCYL1 fusion kinase in NI... FGFR2 FGFR2 FGFR2-AHCYL1 Sensitivity true CIViC Evidence detail
Phase 1 study of FGFR-inhibitor BGJ398 in advanced... FGFR1 FGFR1 AMPLIFICATION
( ENST00000425967.8 ) FGFR1 AMPLIFICATION
( ENST00000425967.8 )
Sensitivity true CIViC Evidence detail
Phase 1 study of FGFR-inhibitor BGJ398 in advanced... FGFR1 FGFR1 AMPLIFICATION
( ENST00000425967.8 ) FGFR1 AMPLIFICATION
( ENST00000425967.8 )
Sensitivity false CIViC Evidence detail
Phase 1 study of FGFR-inhibitor BGJ398 in advanced... FGFR3 FGFR3 MUTATION FGFR3 MUTATION Sensitivity true CIViC Evidence detail
Phase 1 study of FGFR-inhibitor BGJ398 in advanced... FGFR1 FGFR1 AMPLIFICATION
( ENST00000425967.8 ) FGFR1 AMPLIFICATION
( ENST00000425967.8 )
Sensitivity false CIViC Evidence detail
Phase 1 study of FGFR-inhibitor BGJ398 in advanced... FGFR2 FGFR2 MUTATION FGFR2 MUTATION Sensitivity true CIViC Evidence detail
Phase 1 study of FGFR-inhibitor BGJ398 in advanced... FGFR2 FGFR2 FUSION FGFR2 FUSION Sensitivity true CIViC Evidence detail
Targeting of FGFR1 by RNA interference and small-m... FGFR1 FGFR1 EXPRESSION FGFR1 EXPRESSION Sensitivity true CIViC Evidence detail
This Phase II trial of BGJ398 for FGFR2 aberant ch... FGFR2 FGFR2 FUSION FGFR2 FUSION Sensitivity true CIViC Evidence detail
Eight patients with cholangiocarcinoma haboring FG... FGFR2 FGFR2 FUSION FGFR2 FUSION Sensitivity true CIViC Evidence detail
In this one-arm study, 67 patients with metastasti... FGFR3 FGFR3 FGFR3-TACC3 Sensitivity true CIViC Evidence detail
FGFR1 mRNA expression, rather than copy number alt... FGFR1 FGFR1 EXPRESSION FGFR1 EXPRESSION Sensitivity true CIViC Evidence detail
FGFR inhibitor BGJ398 was most effective in a gast... FGFR1 FGFR1 EXPRESSION FGFR1 EXPRESSION Sensitivity true CIViC Evidence detail
In vitro studies showed efficacy of FGFR inhibitor... FGFR1 FGFR1 EXPRESSION FGFR1 EXPRESSION Sensitivity true CIViC Evidence detail
NCT ID Status Phase Summary Start date Completion date
NCT04233567 Active, not recruiting Phase 2 Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations January 16, 2020 December 31, 2023
NCT04228042 Completed Phase 1/Phase 2 Infigratinib Before Surgery for the Treatment of Upper Tract Urothelial Cancer July 28, 2020 April 17, 2024
NCT05145010 Enrolling by invitation Phase 2 Extension Study of Infigratinib in Children With Achondroplasia (ACH) December 6, 2021 February 1, 2032
NCT06206278 Recruiting Phase 2 Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma October 19, 2023 December 2025
NCT04197986 Terminated Phase 3 Oral Infigratinib for the Adjuvant Treatment of Subjects With Invasive Urothelial Carcinoma With Susceptible FGFR3 Genetic Alterations March 11, 2020 February 28, 2023
NCT04424966 Terminated Early Phase 1 Infigratinib in Recurrent High-Grade Glioma Patients July 21, 2020 April 27, 2023
NCT04504331 Terminated Phase 1 Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer October 13, 2020 October 22, 2021
NCT05019794 Unknown status Phase 2 Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations May 13, 2020 December 30, 2023
NCT05222165 Withdrawn Phase 1/Phase 2 Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations October 1, 2021 December 16, 2022
NCT05510427 Withdrawn Phase 1 Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification August 7, 2023 August 7, 2023
NCT04972253 Withdrawn Phase 1 Phase I BLASST-3 Trial December 23, 2021 December 2023