Midostaurin
- Generic Name
- Midostaurin
- Brand Names
- Rydapt
- Drug Type
- Small Molecule
- Chemical Formula
- C35H30N4O4
- CAS Number
- 120685-11-2
- Unique Ingredient Identifier
- ID912S5VON
- Background
Midostaurin (as Rydapt) is a multitarget kinase inhibitor for the treatment for adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3. It was initially characterized as a potential broad-spectrum antineoplastic agent, with activity toward diverse solid and hematopoietic tumors . It was approved on A...
- Indication
Investigated for use/treatment in adult patients with high-risk acute myeloid leukemia (AML) who are FLT3 mutation-positive, agressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).
- Associated Conditions
- Acute Myeloid Leukemia, Aggressive Systemic Mastocytosis, Mast Cell Leukemia (MCL), Systemic Mastocytosis
- Associated Therapies
- -
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)
- Conditions
- First Posted Date
- 2017-04-14
- Last Posted Date
- 2019-10-15
- Lead Sponsor
- Novartis Pharmaceuticals
- Registration Number
- NCT03114228
- Locations
- 🇨🇦
Novartis Investigative Site, Montreal, Quebec, Canada
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
- First Posted Date
- 2017-03-28
- Last Posted Date
- 2024-12-17
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 78
- Registration Number
- NCT03092674
- Locations
- 🇺🇸
Cancer Hematology Centers - Flint, Flint, Michigan, United States
🇺🇸Anchorage Associates in Radiation Medicine, Anchorage, Alaska, United States
🇺🇸Alaska Breast Care and Surgery LLC, Anchorage, Alaska, United States
Midostaurin in Treating Older Patients With Mutated Acute Myeloid Leukemia Post-Transplant
- Conditions
- Interventions
- First Posted Date
- 2016-03-30
- Last Posted Date
- 2018-05-04
- Lead Sponsor
- Stanford University
- Registration Number
- NCT02723435
Midostaurin and Decitabine in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia and FLT3 Mutation
- Conditions
- Interventions
- First Posted Date
- 2015-12-18
- Last Posted Date
- 2019-08-07
- Lead Sponsor
- Mayo Clinic
- Target Recruit Count
- 1
- Registration Number
- NCT02634827
- Locations
- 🇺🇸
Mayo Clinic, Rochester, Minnesota, United States
Midostaurin Access Program for Newly Diagnosed FLT3 (ITD or TKD) Mutated AML Adult Patients Eligible for Standard Induction and Consolidation Chemotherapy
- First Posted Date
- 2015-12-08
- Last Posted Date
- 2020-07-15
- Lead Sponsor
- Novartis Pharmaceuticals
- Registration Number
- NCT02624570
- Locations
- 🇺🇸
City of Hope National Medical Center Department of Hematology & HCT, Duarte, California, United States
🇺🇸The Jordan Research and Education Center ABSMC Comprehensive Cancer Ctr, Berkeley, California, United States
🇺🇸St. Judes Medical Center, Fullerton, California, United States
Cladribine, Idarubicin, Cytarabine, and Venetoclax in Treating Patients with Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, or Blastic Phase Chronic Myeloid Leukemia
- Conditions
- Acute Biphenotypic LeukemiaAcute Myeloid LeukemiaBlast Phase Chronic Myelogenous Leukemia, BCR-ABL1 PositiveBlasts 10 Percent or More of Bone Marrow Nucleated CellsBlasts 10 Percent or More of Peripheral Blood White CellsDe Novo Myelodysplastic SyndromeMyelodysplastic SyndromePreviously Treated Myelodysplastic SyndromeRecurrent Acute Myeloid LeukemiaRecurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Interventions
- First Posted Date
- 2014-04-16
- Last Posted Date
- 2024-12-10
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 508
- Registration Number
- NCT02115295
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML
- Conditions
- Interventions
- First Posted Date
- 2013-06-21
- Last Posted Date
- 2021-03-17
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 60
- Registration Number
- NCT01883362
- Locations
- 🇺🇸
University of California at Los Angeles Oncology, Los Angeles, California, United States
🇺🇸Northside Hospital, Atlanta, Georgia, United States
🇺🇸Washington University School Of Medicine-Siteman Cancer Ctr Washington U School of Med, Saint Louis, Missouri, United States
Decitabine and Midostaurin in Treating Older Patients With Newly Diagnosed Acute Myeloid Leukemia
- Conditions
- AML (Adult) With 11q23 (MLL) AbnormalitiesAML (Adult) With Inv (16) (p13; q22)Acute Myeloid Leukemia (AML) With Multilineage Dysplasia Following Myelodysplastic Syndrome, in AdultsSecondary AML (Adult)Untreated AML (Adult)AML (Adult) With t (16;16) (p13; q22)AML (Adult) With Del (5q)AML (Adult) With t (8; 21) (q22; q22)
- Interventions
- First Posted Date
- 2013-05-03
- Last Posted Date
- 2018-09-27
- Lead Sponsor
- David Iberri
- Target Recruit Count
- 13
- Registration Number
- NCT01846624
- Locations
- 🇺🇸
Stanford University School of Medicine, Stanford, California, United States
Protocol in Acute Myeloid Leukemia With FLT3-ITD
- Conditions
- Interventions
- First Posted Date
- 2011-11-22
- Last Posted Date
- 2020-06-04
- Lead Sponsor
- University of Ulm
- Target Recruit Count
- 451
- Registration Number
- NCT01477606
- Locations
- 🇦🇹
Krankenhaus der Elisabethinen Linz GmbH, Linz, Austria
🇩🇪Helios Klinikum Bad Saarow, Bad Saarow, Germany
🇩🇪Städtisches Klinikum Braunschweig gGmbH, Braunschweig, Germany
PK and Safety of Midostaurin in Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function
- First Posted Date
- 2011-09-07
- Last Posted Date
- 2021-05-12
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 43
- Registration Number
- NCT01429337
- Locations
- 🇷🇴
Novartis Investigative Site, Cluj, Napoca, Romania
🇺🇸American Research Corporation Inc, San Antonio, Texas, United States
Drug Development Updates
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