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
- -
Midostaurin (PKC412) for Locally Advanced Rectal Cancer
- First Posted Date
- 2011-01-25
- Last Posted Date
- 2018-12-12
- Lead Sponsor
- Massachusetts General Hospital
- Target Recruit Count
- 19
- Registration Number
- NCT01282502
- Locations
- 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸Dana Farber Cancer Institute, Boston, Massachusetts, United States
Phase I Combination of Midostaurin, Bortezomib, and Chemo in Relapsed/Refractory Acute Myeloid Leukemia
- Conditions
- Acute Myeloid Leukemia With Multilineage Dysplasia FollowingAdult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Inv(16)(p13;q22)Acute Myeloid LeukemiaMyelodysplastic SyndromeAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Recurrent Adult Acute Myeloid Leukemia
- Interventions
- First Posted Date
- 2010-08-04
- Last Posted Date
- 2016-07-06
- Lead Sponsor
- Alison Walker
- Target Recruit Count
- 34
- Registration Number
- NCT01174888
- Locations
- 🇺🇸
The Ohio State University Medical Center, Columbus, Ohio, United States
Cladribine Based Induction Therapy With All-Trans Retinoic Acid and Midostaurin in Relapsed/Refractory AML
- First Posted Date
- 2010-07-13
- Last Posted Date
- 2013-07-23
- Lead Sponsor
- Washington University School of Medicine
- Target Recruit Count
- 11
- Registration Number
- NCT01161550
- Locations
- 🇺🇸
Washington University School of Medicine, St. Louis, Missouri, United States
Midostaurin and Azacitidine in Treating Elderly Patients With Acute Myelogenous Leukemia
- Conditions
- Interventions
- First Posted Date
- 2010-03-26
- Last Posted Date
- 2022-06-30
- Lead Sponsor
- Brenda Cooper, MD
- Target Recruit Count
- 34
- Registration Number
- NCT01093573
- Locations
- 🇺🇸
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
🇺🇸West Virginia University, Morgantown, West Virginia, United States
A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia
- Conditions
- Interventions
- First Posted Date
- 2009-03-20
- Last Posted Date
- 2015-12-22
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 22
- Registration Number
- NCT00866281
- Locations
- 🇺🇸
Seattle Children's Hospital CPKC412A2114, Seattle, Washington, United States
🇸🇪Novartis Investigative Site, Stockholm, Sweden
Daunorubicin, Cytarabine, and Midostaurin in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
- Conditions
- Interventions
- First Posted Date
- 2008-04-02
- Last Posted Date
- 2021-08-18
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Target Recruit Count
- 717
- Registration Number
- NCT00651261
- Locations
- 🇺🇸
St. Luke's Regional Medical Center, Sioux City, Iowa, United States
🇺🇸Ministry Saint Clare's Hospital, Weston, Wisconsin, United States
🇺🇸Cancer Centers of the Carolinas - Easley, Easley, South Carolina, United States
Phase 2 Midostaurin in Aggressive Systemic Mastocytosis and Mast Cell Leukemia
- Conditions
- Interventions
- First Posted Date
- 2005-10-05
- Last Posted Date
- 2018-09-20
- Lead Sponsor
- Jason Robert Gotlib
- Target Recruit Count
- 26
- Registration Number
- NCT00233454
- Locations
- 🇺🇸
Stanford University School of Medicine, Stanford, California, United States
🇺🇸Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Washington University-St. Louis, Saint Louis, Missouri, United States
PKC412, Daunorubicin, and Cytarabine in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
- Conditions
- Interventions
- First Posted Date
- 2004-10-08
- Last Posted Date
- 2020-12-19
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 69
- Registration Number
- NCT00093600
- Locations
- 🇺🇸
Dana Faber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California, United States
🇺🇸Wayne State University/Karmanos Cancer Institute, Detroit, Michigan, United States
Drug Development Updates
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