Crenolanib

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Information
Drug Name
Crenolanib
Description
Entry(CIViC)
9
CIViC
Disease Mutation EL ET ED CS VO TR Pubmed Links
melanoma PDGFRA p.Pro577Ser (p.P577S), ENSG00000282278 c.1018-9C>T
( ENST00000257290.10 ) PDGFRA p.Pro577Ser (p.P577S), ENSG00000282278 c.1018-9C>T
( ENST00000257290.10 ) 		D Predictive Supports Sensitivity/Response Somatic 3 24132921 Detail
melanoma PDGFRA p.Arg841Lys (p.R841K), ENSG00000282278 p.Arg601Lys (p.R601K)
( ENST00000257290.10 ) PDGFRA p.Arg841Lys (p.R841K), ENSG00000282278 p.Arg601Lys (p.R601K)
( ENST00000257290.10 ) 		D Predictive Supports Sensitivity/Response 3 24132921 Detail
melanoma PDGFRA p.His845Tyr (p.H845Y), ENSG00000282278 p.His605Tyr (p.H605Y)
( ENST00000257290.10 ) PDGFRA p.His845Tyr (p.H845Y), ENSG00000282278 p.His605Tyr (p.H605Y)
( ENST00000257290.10 ) 		D Predictive Supports Sensitivity/Response Somatic 3 24132921 Detail
melanoma PDGFRA p.Gly853Asp (p.G853D), ENSG00000282278 p.Gly613Asp (p.G613D)
( ENST00000257290.10 ) PDGFRA p.Gly853Asp (p.G853D), ENSG00000282278 p.Gly613Asp (p.G613D)
( ENST00000257290.10 ) 		D Predictive Supports Sensitivity/Response Somatic 3 24132921 Detail
gastrointestinal stromal tumor PDGFRA p.Asp842Ile (p.D842I), ENSG00000282278 p.Asp602Ile (p.D602I)
( ENST00000257290.10 ) PDGFRA p.Asp842Ile (p.D842I), ENSG00000282278 p.Asp602Ile (p.D602I)
( ENST00000257290.10 ) 		D Predictive Supports Sensitivity/Response Somatic 4 22745105 Detail
gastrointestinal stromal tumor PDGFRA p.Asp842Val (p.D842V), ENSG00000282278 p.Asp602Val (p.D602V)
( ENST00000257290.10 ) PDGFRA p.Asp842Val (p.D842V), ENSG00000282278 p.Asp602Val (p.D602V)
( ENST00000257290.10 ) 		D Predictive Supports Sensitivity/Response Somatic 4 22745105 Detail
gastrointestinal stromal tumor PDGFRA p.Asp842Tyr (p.D842Y), ENSG00000282278 p.Asp602Tyr (p.D602Y)
( ENST00000257290.10 ) PDGFRA p.Asp842Tyr (p.D842Y), ENSG00000282278 p.Asp602Tyr (p.D602Y)
( ENST00000257290.10 ) 		D Predictive Supports Sensitivity/Response Somatic 4 22745105 Detail
gastrointestinal stromal tumor PDGFRA p.Ile843del (p.I843del), ENSG00000282278 p.Ile603del (p.I603del)
( ENST00000257290.10 ) PDGFRA p.Ile843del (p.I843del), ENSG00000282278 p.Ile603del (p.I603del)
( ENST00000257290.10 ) 		D Predictive Supports Sensitivity/Response Somatic 3 22745105 Detail
gastrointestinal stromal tumor PDGFRA p.Asp842_Ile843delinsValMet (p.D842_I843delinsVM), ENSG00000282278 p.Asp602_Ile603delinsValMet (p.D602_I603delinsVM)
( ENST00000257290.10 ) PDGFRA p.Asp842_Ile843delinsValMet (p.D842_I843delinsVM), ENSG00000282278 p.Asp602_Ile603delinsValMet (p.D602_I603delinsVM)
( ENST00000257290.10 ) 		D Predictive Supports Sensitivity/Response Somatic 4 22745105 Detail
Annotation
Description Associated Genes Associated Variants Sensitivity Supported Source Links
Five PDGFRA Mutations (P577S, V658A, R841K, H845Y,... PDGFRA PDGFRA p.Pro577Ser (p.P577S), ENSG00000282278 c.1018-9C>T
( ENST00000257290.10 ) PDGFRA p.Pro577Ser (p.P577S), ENSG00000282278 c.1018-9C>T
( ENST00000257290.10 ) 		Sensitivity true CIViC Evidence detail
Five PDGFRA Mutations (P577S, V658A, R841K, H845Y,... PDGFRA PDGFRA p.Arg841Lys (p.R841K), ENSG00000282278 p.Arg601Lys (p.R601K)
( ENST00000257290.10 ) PDGFRA p.Arg841Lys (p.R841K), ENSG00000282278 p.Arg601Lys (p.R601K)
( ENST00000257290.10 ) 		Sensitivity true CIViC Evidence detail
Five PDGFRA Mutations (P577S, V658A, R841K, H845Y,... PDGFRA PDGFRA p.His845Tyr (p.H845Y), ENSG00000282278 p.His605Tyr (p.H605Y)
( ENST00000257290.10 ) PDGFRA p.His845Tyr (p.H845Y), ENSG00000282278 p.His605Tyr (p.H605Y)
( ENST00000257290.10 ) 		Sensitivity true CIViC Evidence detail
Five PDGFRA Mutations (P577S, V658A, R841K, H845Y,... PDGFRA PDGFRA p.Gly853Asp (p.G853D), ENSG00000282278 p.Gly613Asp (p.G613D)
( ENST00000257290.10 ) PDGFRA p.Gly853Asp (p.G853D), ENSG00000282278 p.Gly613Asp (p.G613D)
( ENST00000257290.10 ) 		Sensitivity true CIViC Evidence detail
In CHO cells with PDGFRA D842I mutation that have ... PDGFRA PDGFRA p.Asp842Ile (p.D842I), ENSG00000282278 p.Asp602Ile (p.D602I)
( ENST00000257290.10 ) PDGFRA p.Asp842Ile (p.D842I), ENSG00000282278 p.Asp602Ile (p.D602I)
( ENST00000257290.10 ) 		Sensitivity true CIViC Evidence detail
In CHO cells with PDGFRA D842V mutation that have ... PDGFRA PDGFRA p.Asp842Val (p.D842V), ENSG00000282278 p.Asp602Val (p.D602V)
( ENST00000257290.10 ) PDGFRA p.Asp842Val (p.D842V), ENSG00000282278 p.Asp602Val (p.D602V)
( ENST00000257290.10 ) 		Sensitivity true CIViC Evidence detail
In CHO cells with PDGFRA D842Y mutation that have ... PDGFRA PDGFRA p.Asp842Tyr (p.D842Y), ENSG00000282278 p.Asp602Tyr (p.D602Y)
( ENST00000257290.10 ) PDGFRA p.Asp842Tyr (p.D842Y), ENSG00000282278 p.Asp602Tyr (p.D602Y)
( ENST00000257290.10 ) 		Sensitivity true CIViC Evidence detail
In CHO cells with the PDGFRA deletion I843 mutatio... PDGFRA PDGFRA p.Ile843del (p.I843del), ENSG00000282278 p.Ile603del (p.I603del)
( ENST00000257290.10 ) PDGFRA p.Ile843del (p.I843del), ENSG00000282278 p.Ile603del (p.I603del)
( ENST00000257290.10 ) 		Sensitivity true CIViC Evidence detail
In CHO cells with PDGFRA DI842-843VM mutation that... PDGFRA PDGFRA p.Asp842_Ile843delinsValMet (p.D842_I843delinsVM), ENSG00000282278 p.Asp602_Ile603delinsValMet (p.D602_I603delinsVM)
( ENST00000257290.10 ) PDGFRA p.Asp842_Ile843delinsValMet (p.D842_I843delinsVM), ENSG00000282278 p.Asp602_Ile603delinsValMet (p.D602_I603delinsVM)
( ENST00000257290.10 ) 		Sensitivity true CIViC Evidence detail
NCT ID Status Phase Summary Start date Completion date
NCT01393912 Completed Phase 1 PDGFR Inhibitor Crenolanib in Children/Young Adults With Diffuse Intrinsic Pontine Glioma or Recurrent High-Grade Glioma July 2011 October 2016
NCT02270788 Completed Phase 1 Crenolanib in Combination With Sorafenib in Patients With Refractory or Relapsed Hematologic Malignancies April 2, 2015 October 17, 2016
NCT02283177 Completed Phase 2 A Safety and Tolerability Study of Crenolanib in Combination With Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia Patients With FLT3 Mutations January 2015 December 2019
NCT02626338 Completed Phase 1/Phase 2 Pilot Study of Crenolanib Combined With Standard Salvage Chemotherapy in Subjects With R/R AML February 2016 February 2018
NCT02626364 Completed Phase 2 Study of Crenolanib in Recurrent/Refractory Glioblastoma With PDGFRA Gene Amplification April 2016 July 2020
NCT03193918 Completed Phase 1 Study of Crenolanib With Ramucirumab and Paclitaxel for Advanced Esophagogastric Adenocarcinoma April 14, 2017 July 15, 2020
NCT03250338 Recruiting Phase 3 Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML June 5, 2018 October 2024
NCT03258931 Recruiting Phase 3 Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML August 15, 2018 November 2024
NCT02298166 Terminated Phase 3 Study of Crenolanib in Combination With Chemotherapy in Patients With Relapsed or Refractory Acute Myeloid Leukemia and Activating FLT3 Mutations November 17, 2016 March 9, 2020
NCT02847429 Unknown status Phase 3 Randomized Trial of Crenolanib in Subjects With D842V Mutated GIST August 2016 August 2021
NCT03324243 Withdrawn Phase 2 A Study of Crenolanib With Fludarabine and Cytarabine in Pediatric Patients With Relapsed/Refractory FLT3-Mutated Acute Myeloid Leukemia January 2018 December 2020