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Clinical trials for Midostaurin

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   44339   clinical trials with a EudraCT protocol, of which   7369   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    18 result(s) found for: Midostaurin. Displaying page 1 of 1.
    EudraCT Number: 2012-004868-22 Sponsor Protocol Number: UMCG41973 Start Date*: 2013-07-09
    Sponsor Name:University Medical Center Groningen
    Full Title: Phase II single arm open pilot study to demonstrate the efficacy of midostaurin in symptom improvement and decrease of mast cell burden in patients with indolent or smoldering systemic mastocytosis
    Medical condition: Indolent or smoldering mastocytosis
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2019-000136-26 Sponsor Protocol Number: MAURITIUS Start Date*: 2020-02-26
    Sponsor Name:Friedrich-Schiller-Universität Jena
    Full Title: Midostaurin in MRD positive acute myeloid leukemia after allogeneic stem cell transplantation
    Medical condition: Acute Myeloid Leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10066764 Acute myeloid leukaemia progression LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2008-006931-11 Sponsor Protocol Number: CPKC412A2114 Start Date*: 2009-11-09
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase I/II, open-label, dose-escalating study to evaluate the safety, tolerability and pharmacokinetics of twice daily oral midostaurin and to evaluate the preliminary clinical and pharmacodynami...
    Medical condition: in pediatric patients with relapsed or refractory leukemia
    Disease: Version SOC Term Classification Code Term Level
    12.0 10000835 Acute leukemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (Completed) SE (Prematurely Ended) NL (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-004440-12 Sponsor Protocol Number: CPKC412A2408 Start Date*: 2017-11-12
    Sponsor Name:Novartis Pharma AG
    Full Title: An open-label, multicenter, Phase IIIb study to assess the safety and efficacy of midostaurin (PKC412) in patients 18 years of age or older with newly-diagnosed FLT3-mutated Acute Myeloid Leukemia ...
    Medical condition: newly diagnosed FLT3 mutated acute myeloid leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) FI (Completed) CZ (Completed) ES (Ongoing) HU (Completed) FR (Completed) BG (Completed) GR (Completed) SK (Completed) LT (Completed) IT (Completed) EE (Completed) HR (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2017-003540-21 Sponsor Protocol Number: CPKC412E2301 Start Date*: 2018-05-23
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase III, randomized, double-blind study of chemotherapy with daunorubicin or idarubicin and cytarabine for induction and intermediate dose cytarabine for consolidation plus midostaurin (PKC412...
    Medical condition: newly diagnosed FLT3 non-mutated acute myeloid leukemia
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) BE (Completed) IT (Completed) PT (Completed) FR (Completed) NO (Completed) ES (Prematurely Ended) AT (Completed) HU (Prematurely Ended) BG (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2011-003168-63 Sponsor Protocol Number: AMLSG16-10/CPKC412ADE02T Start Date*: 2012-04-27
    Sponsor Name:University Hospital Ulm
    Full Title: Phase-II study evaluating midostaurin in induction, consolidation and maintenance therapy also after allogeneic blood stem cell transplantation in patients with newly diagnosed acute myeloid leuk...
    Medical condition: Patients with confirmed diagnosis of AML or related precursor neoplasm, or acute leukemia of ambiguous lineage (classified according to the World Health Organization (WHO) 2008 classification)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2011-002567-17 Sponsor Protocol Number: TUD-MIDOKI-052 Start Date*: 2012-03-15
    Sponsor Name:Technische Universität Dresden
    Full Title: A single-arm phase II trial to assess the efficacy of Midostaurin (PKC412) added to standard primary therapy in patients with newly diagnosed c-KIT or FLT3-ITD mutated t(8;21) AML
    Medical condition: Patients with newly diagnosed c-KIT or FLT3-ITD mutated t(8;21) AML
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10060557 Acute myelocytic leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-000280-42 Sponsor Protocol Number: CPKC412D2201 Start Date*: 2008-08-07
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A single arm, Phase II, Open-label Study to determine the efficacy of 100 mg twice daily oral dosing of midostaurin administered to patients with Agressive Systemic Mastocytosis or Mast Cell Leukem...
    Medical condition: Agressive Systemic Mastocytosis (ASM) or Mast Cell Leukemia (MCL) +/- an Associated Hematological Clonal Non-Mast Cell Lineage Disease (AHNMD)
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004851 10056453 Aggressive systemic mastocytosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: BE (Completed) FR (Completed) IT (Completed) DE (Completed) NO (Completed) AT (Completed) GB (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2017-004830-28 Sponsor Protocol Number: CPKC412A2218 Start Date*: 2018-11-02
    Sponsor Name:Novartis Pharma AG
    Full Title: A Phase II, open-label, single arm study to evaluate the safety, efficacy, and pharmacokinetics of twice daily midostaurin (PKC412) combined with standard chemotherapy and as a single agent post-co...
    Medical condition: untreated FLT3-mutated acute myeloid leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000886 Acute myeloid leukemia LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: CZ (Trial now transitioned) SI (Trial now transitioned) AT (Trial now transitioned) PL (Trial now transitioned) DE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-000624-33 Sponsor Protocol Number: HO156_AMLSG28/18 Start Date*: 2019-08-01
    Sponsor Name:HOVON Foundation
    Full Title: A phase 3, multicenter, open-label, randomized, study of gilteritinib versus midostaurin in combination with induction and consolidation therapy followed by one-year maintenance in patients with ne...
    Medical condition: Previously untreated Acute Myeloid Leukemia (AML) or Myelodysplastic syndromes with excess blasts-2 (MDS-EB2) with FLT3 mutations
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10001941 AML LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10068361 MDS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) SE (Trial now transitioned) LT (Trial now transitioned) BE (Trial now transitioned) FI (Trial now transitioned) FR (Trial now transitioned) IE (Trial now transitioned) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-006852-37 Sponsor Protocol Number: CPKC412A2301 Start Date*: 2008-07-11
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A phase III randomized, double-blind study of induction(daunorubicin/cytarabine)and consolidation (high dose cytarabine) chemotherapy + midostaurin (PKC412) or placebo in newly diagnosed patients <...
    Medical condition: newly diagnosed FLT3 mutated acute myeloid leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) AT (Completed) CZ (Completed) NL (Completed) SK (Completed) HU (Completed) BE (Completed) IT (Completed) FR (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-002094-18 Sponsor Protocol Number: REL-AML001/2017 Start Date*: 2018-05-18
    Sponsor Name:AZIENDA OSPEDALIERA AO OSPEDALE NIGUARDA CA' GRANDA
    Full Title: Prospective evaluation of a continuation therapy with Midostaurin in adult patients with core-binding factor leukemia and integrated genetic analysis: a multi-center phase II study
    Medical condition: Acute Myeloid Leukemia (AML)
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-000047-31 Sponsor Protocol Number: HOVON155 Start Date*: 2019-09-30
    Sponsor Name:HOVON Foundation
    Full Title: A randomized phase II multicenter study to assess the tolerability and efficacy of the addition of midostaurin to 10-day decitabine in UNFIT (i.e. HCT-CI ≥ 3) adult AML and high risk myelodysplasia...
    Medical condition: Acute Meyloid Leukemia and high risk myelodysplastic syndromes
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000886 Acute myeloid leukemia LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-003863-23 Sponsor Protocol Number: TUD-MOSAIC-075 Start Date*: 2020-07-03
    Sponsor Name:Technische Universität Dresden
    Full Title: Midostaurin + Gemtuzumab Ozogamicin combination in first-line standard therapy for acute myeloid leukemia
    Medical condition: Patients with newly diagnosed acute myeloid leukemia (AML) fit for intensive curative treatment displaying a cytogenetic aberration or fusion transcript in the core-binding factor (CBF) genes or FL...
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2018-003107-19 Sponsor Protocol Number: CHDM201A2101 Start Date*: 2019-03-13
    Sponsor Name:Novartis Pharma AG
    Full Title: A phase I/II multi-center study of HDM201 added to chemotherapy in adult subjects with relapsed/refractory (R/R) or newly diagnosed acute myeloid leukemia (AML)
    Medical condition: Relapsed refractory (R/R) or newly diagnosed acute myeloid leukemia (AML)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) FR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-002195-90 Sponsor Protocol Number: SPON1334-14 Start Date*: Information not available in EudraCT
    Sponsor Name:Cardiff University
    Full Title: Adults with acute myeloid leukaemia or high-risk myelodysplastic syndrome (AML19)
    Medical condition: Acute myeloid leukaemia High Risk Myelodysplastic Syndrome (trial arm for this patient group is now closed awaiting final analysis)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10028533 Myelodysplastic syndrome PT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000880 Acute myeloid leukaemia PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2021-000761-33 Sponsor Protocol Number: KB-ENTO-3001 Start Date*: 2022-01-03
    Sponsor Name:Kronos Bio, Inc.
    Full Title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Entospletinib in Combination With Intensive Induction and Consolidation Chemotherapy in Adults Wit...
    Medical condition: Acute Myeloid Leukemia
    Disease: Version SOC Term Classification Code Term Level
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10000886 Acute myeloid leukemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) ES (Prematurely Ended) HU (Prematurely Ended) CZ (Prematurely Ended) IT (Prematurely Ended) FR (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-004836-13 Sponsor Protocol Number: BLU-285-2202 Start Date*: 2018-12-29
    Sponsor Name:Blueprint Medicines Corporation
    Full Title: An Open-label, Single Arm, Phase 2 Study to Evaluate Efficacy and Safety of Avapritinib (BLU-285), A Selective KIT Mutation-targeted Tyrosine Kinase Inhibitor, in Patients with Advanced Systemic Ma...
    Medical condition: Advanced Systemic Mastocytosis (AdvSM)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10056453 Aggressive systemic mastocytosis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) GB (GB - no longer in EU/EEA) NO (Completed) DE (Completed) ES (Ongoing) PL (Completed) FR (Completed) AT (Completed) IT (Completed)
    Trial results: (No results available)
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