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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR MIDOSTAURIN

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Clinical Trials for Midostaurin

Trial ID Title Status Sponsor Phase Summary
NCT00093600 PKC412, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Completed Novartis Pharmaceuticals Phase 1 RATIONALE: PKC412 may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It may also increase the effectiveness of daunorubicin and cytarabine by making cancer cells more sensitive to the drugs. Drugs used in chemotherapy, such as daunorubicin and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining PKC412 with chemotherapy may kill more cancer cells. PURPOSE: This phase I trial is studying the side effects and best way to give PKC412 when given either after or together with daunorubicin and cytarabine in treating patients with newly diagnosed acute myeloid leukemia.
NCT00233454 Phase II Midostaurin in Aggressive Systemic Mastocytosis and Mast Cell Leukemia Active, not recruiting Novartis Phase 2 The safety and efficacy of midostaurin (PKC412), a novel investigational drug, will be evaluated on the basis of response rate, when administered to patients with aggressive systemic mastocytosis (ASM) or mast cell leukemia (MCL)
NCT00233454 Phase II Midostaurin in Aggressive Systemic Mastocytosis and Mast Cell Leukemia Active, not recruiting Novartis Pharmaceuticals Phase 2 The safety and efficacy of midostaurin (PKC412), a novel investigational drug, will be evaluated on the basis of response rate, when administered to patients with aggressive systemic mastocytosis (ASM) or mast cell leukemia (MCL)
NCT00233454 Phase II Midostaurin in Aggressive Systemic Mastocytosis and Mast Cell Leukemia Active, not recruiting Jason Robert Gotlib Phase 2 The safety and efficacy of midostaurin (PKC412), a novel investigational drug, will be evaluated on the basis of response rate, when administered to patients with aggressive systemic mastocytosis (ASM) or mast cell leukemia (MCL)
NCT00651261 Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Active, not recruiting National Cancer Institute (NCI) Phase 3 The purpose of this study is to compare the effects, good and/or bad, of a standard chemotherapy regimen for AML that includes the drugs daunorubicin and cytarabine combined with or without midostaurin (also known as PKC412), to find out which is better. This research is being done because it is unknown whether the addition of midostaurin to chemotherapy treatment is better than chemotherapy treatment alone. Midostaurin has been tested in over 400 patients and is being studied in a number of illnesses, including AML, colon cancer, and lung cancer. Midostaurin blocks an enzyme, produced by a gene known as FLT3, that may have a role in the survival and growth of AML cells. Not all leukemia cells will have the abnormal FLT3 gene. This study will focus only on patients with leukemia cells with the abnormal FLT3 gene.
NCT00651261 Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia Active, not recruiting Novartis Pharmaceuticals Phase 3 The purpose of this study is to compare the effects, good and/or bad, of a standard chemotherapy regimen for AML that includes the drugs daunorubicin and cytarabine combined with or without midostaurin (also known as PKC412), to find out which is better. This research is being done because it is unknown whether the addition of midostaurin to chemotherapy treatment is better than chemotherapy treatment alone. Midostaurin has been tested in over 400 patients and is being studied in a number of illnesses, including AML, colon cancer, and lung cancer. Midostaurin blocks an enzyme, produced by a gene known as FLT3, that may have a role in the survival and growth of AML cells. Not all leukemia cells will have the abnormal FLT3 gene. This study will focus only on patients with leukemia cells with the abnormal FLT3 gene.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Midostaurin

Condition Name

Condition Name for Midostaurin
Intervention Trials
Acute Myeloid Leukemia 9
Leukemia 3
Untreated Adult Acute Myeloid Leukemia 3
Myelodysplastic Syndrome 2
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Condition MeSH

Condition MeSH for Midostaurin
Intervention Trials
Leukemia, Myeloid, Acute 20
Leukemia, Myeloid 20
Leukemia 20
Myelodysplastic Syndromes 5
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Clinical Trial Locations for Midostaurin

Trials by Country

Trials by Country for Midostaurin
Location Trials
United States 108
Italy 10
Germany 8
Canada 7
Australia 6
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Trials by US State

Trials by US State for Midostaurin
Location Trials
California 8
Massachusetts 7
Texas 6
Michigan 5
Missouri 4
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Clinical Trial Progress for Midostaurin

Clinical Trial Phase

Clinical Trial Phase for Midostaurin
Clinical Trial Phase Trials
Phase 3 3
Phase 2/Phase 3 1
Phase 2 13
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Clinical Trial Status

Clinical Trial Status for Midostaurin
Clinical Trial Phase Trials
Recruiting 9
Active, not recruiting 6
Not yet recruiting 6
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Clinical Trial Sponsors for Midostaurin

Sponsor Name

Sponsor Name for Midostaurin
Sponsor Trials
Novartis Pharmaceuticals 15
National Cancer Institute (NCI) 6
Novartis 3
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Sponsor Type

Sponsor Type for Midostaurin
Sponsor Trials
Industry 21
Other 17
NIH 6
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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Daiichi Sankyo
Accenture
QuintilesIMS
Fish and Richardson
McKesson
Moodys
Johnson and Johnson
AstraZeneca

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