Midostaurin

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Information
Drug Name
Midostaurin
Description
Entry(CIViC)
4
CIViC
Disease Mutation EL ET ED CS VO TR Pubmed Links
myeloproliferative neoplasm FGFR1 ZNF198-FGFR1 FGFR1 ZNF198-FGFR1 C Predictive Supports Sensitivity/Response Somatic 4 15448205 Detail
acute myeloid leukemia FLT3 p.Asp835Tyr (p.D835Y)
( ENST00000241453.12 ) FLT3 p.Asp835Tyr (p.D835Y)
( ENST00000241453.12 ) 		B Predictive Supports Sensitivity/Response Somatic 3 20733134 Detail
systemic mastocytosis KIT p.Asp817Val (p.D817V)
( ENST00000288135.6, ENST00000412167.7, ENST00000686011.1, ENST00000687109.1, ENST00000687246.1, ENST00000687295.1, ENST00000689832.1, ENST00000689994.1, ENST00000690543.1, ENST00000692783.1 ) KIT p.Asp817Val (p.D817V)
( ENST00000686011.1, ENST00000687109.1, ENST00000288135.6, ENST00000412167.7, ENST00000687246.1, ENST00000687295.1, ENST00000689832.1, ENST00000689994.1, ENST00000690543.1, ENST00000692783.1 ) 		B Predictive Supports Sensitivity/Response Somatic 4 27355533 Detail
acute myeloid leukemia FLT3 MUTATION FLT3 MUTATION A Predictive Supports Sensitivity/Response Somatic 3 28546144 Detail
Annotation
Description Associated Genes Associated Variants Sensitivity Supported Source Links
A t(8;13)(p11;q12) patient with ZNF198-FGFR1-induc... FGFR1 FGFR1 ZNF198-FGFR1 FGFR1 ZNF198-FGFR1 Sensitivity true CIViC Evidence detail
In a phase 2 clinical study of 95 AML/high-risk MD... FLT3 FLT3 p.Asp835Tyr (p.D835Y)
( ENST00000241453.12 ) FLT3 p.Asp835Tyr (p.D835Y)
( ENST00000241453.12 ) 		Sensitivity true CIViC Evidence detail
In a phase II clinical trial, 60% of patients (N=8... KIT KIT p.Asp817Val (p.D817V)
( ENST00000288135.6, ENST00000412167.7, ENST00000686011.1, ENST00000687109.1, ENST00000687246.1, ENST00000687295.1, ENST00000689832.1, ENST00000689994.1, ENST00000690543.1, ENST00000692783.1 ) KIT p.Asp817Val (p.D817V)
( ENST00000686011.1, ENST00000687109.1, ENST00000288135.6, ENST00000412167.7, ENST00000687246.1, ENST00000687295.1, ENST00000689832.1, ENST00000689994.1, ENST00000690543.1, ENST00000692783.1 ) 		Sensitivity true CIViC Evidence detail
Midostaurin is FDA-approved for the treatment of n... FLT3 FLT3 MUTATION FLT3 MUTATION Sensitivity true CIViC Evidence detail
NCT ID Status Phase Summary Start date Completion date
NCT04097470 Active, not recruiting Phase 2 Tolerability and Efficacy of Midostaurin to 10-day Decitabine in Unfit Adult AML and High Risk MDS Patients December 5, 2019 November 2026
NCT03836209 Active, not recruiting Phase 2 Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia December 6, 2019 December 2024
NCT04027309 Active, not recruiting Phase 3 A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy December 20, 2019 June 2033
NCT03092674 Active, not recruiting Phase 2/Phase 3 Azacitidine With or Without Nivolumab or Midostaurin, or Decitabine and Cytarabine Alone in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome February 2, 2018 October 29, 2024
NCT05219266 Available Managed Access Programs for PKC412, Midostaurin
NCT01161550 Completed Phase 1 Cladribine Based Induction Therapy With All-Trans Retinoic Acid and Midostaurin in Relapsed/Refractory AML November 2010 August 2012
NCT01174888 Completed Phase 1 Phase I Combination of Midostaurin, Bortezomib, and Chemo in Relapsed/Refractory Acute Myeloid Leukemia August 2010 May 2016
NCT01282502 Completed Phase 1 Midostaurin (PKC412) for Locally Advanced Rectal Cancer August 2011 December 2018
NCT01429337 Completed Phase 1 PK and Safety of Midostaurin in Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function March 7, 2011 May 9, 2020
NCT01477606 Completed Phase 2 Protocol in Acute Myeloid Leukemia With FLT3-ITD May 2012 February 26, 2020
NCT01883362 Completed Phase 2 Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML February 6, 2014 April 30, 2018
NCT04075747 Completed Phase 1 A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia December 2, 2019 September 12, 2023
NCT03280030 Completed Phase 2 A Study of Midostaurin Efficacy and Safety in Newly Diagnosed Patients With FLT3-mutated AML April 6, 2018 November 14, 2022
NCT00233454 Completed Phase 2 Phase 2 Midostaurin in Aggressive Systemic Mastocytosis and Mast Cell Leukemia March 2005 April 16, 2011
NCT00093600 Completed Phase 1 PKC412, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia February 2004 June 2011
NCT05488613 Completed Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML) September 24, 2020 January 26, 2021
NCT01093573 Completed Phase 1/Phase 2 Midostaurin and Azacitidine in Treating Elderly Patients With Acute Myelogenous Leukemia July 2009 May 5, 2017
NCT03512197 Completed Phase 3 A Global Study of the Efficacy and Safety of Midostaurin + Chemotherapy in Newly Diagnosed Patients With FLT3 Mutation Negative (FLT3-MN) Acute Myeloid Leukemia (AML) July 20, 2018 February 12, 2021
NCT03379727 Completed Phase 3 Study to Assess the Safety and Efficacy of Midostaurin (PKC412) in Combination With Standard Chemotherapy During Induction and Consolidation Followed by 12 Months of Maintenance Monotherapy in Patients With Newly-diagnosed FMS-like Tyrosine 3 (FLT3) Kinase Receptor-mutated Acute Myeloid Leukemia. February 13, 2018 July 9, 2021
NCT03114228 No longer available An Expanded Treatment Protocol (ETP) of Midostaurin (PKC412) in Patients 18 Years of Age or Older With Newly-diagnosed FLT3-mutated Acute Myeloid Leukemia (AML)
NCT02624570 No longer available Midostaurin Access Program for Newly Diagnosed FLT3 (ITD or TKD) Mutated AML Adult Patients Eligible for Standard Induction and Consolidation Chemotherapy
NCT06313437 Not yet recruiting Phase 1 Revumenib in Combination With 7+3 + Midostaurin in AML September 2024 March 2, 2027
NCT04982354 Recruiting Phase 1/Phase 2 Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia July 5, 2022 August 1, 2032
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
NCT03686345 Recruiting Phase 2 Midostaurin Associated With Standard Chemotherapy in Patients With Core-binding Factor Leukemia July 1, 2018 December 31, 2025
NCT02115295 Recruiting Phase 2 Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients With Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia May 19, 2014 May 31, 2026
NCT04174612 Recruiting Phase 3 AML Patients Bearing FLT3 Mutations Based on Peripheral Blast Clearance April 24, 2020 August 1, 2025
NCT03591510 Recruiting Phase 2 A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML March 13, 2019 February 15, 2029
NCT03900949 Suspended Phase 1 Gentuzumab Ozogamicin and Midostaurin Combination With Standard Cytarabine and Danunorubi Midostaurin as a Novel Approach to Treating Patients With Newly Diagnosed FLT-3 Mutated Acute Myeloid Leukemia March 13, 2019 January 1, 2025
NCT02634827 Terminated Phase 2 Midostaurin and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mutation December 30, 2015 June 12, 2018
NCT03951961 Terminated Phase 2 Midostaurin in MRD (Minimal Residual Disease) Positive Acute Myeloid Leukemia After Allogeneic Stem Cell Transplantation March 20, 2020 February 28, 2021
NCT04496999 Terminated Phase 1 HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt. July 13, 2020 September 9, 2022
NCT01846624 Terminated Phase 2 Decitabine and Midostaurin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia June 2013 August 31, 2016
NCT00866281 Terminated Phase 1/Phase 2 A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia September 2009 September 2014
NCT00651261 Unknown status Phase 3 Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia April 2008
NCT03760445 Withdrawn Phase 1/Phase 2 HDM201 Added to CT in R/R or Newly Diagnosed AML November 15, 2019 June 13, 2023
NCT02723435 Withdrawn Phase 2 Midostaurin in Treating Older Patients With Mutated Acute Myeloid Leukemia Post-Transplant April 2018
NCT03207334 Withdrawn Phase 2 iCare4: Genomic Signatures With Midostaurin in Acute Myeloid Leukemia (UF-HEM-004) November 2018 January 2022