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
- -
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
- Conditions
- Interventions
- First Posted Date
- 2019-04-03
- Last Posted Date
- 2024-12-20
- Lead Sponsor
- Uma Borate
- Target Recruit Count
- 18
- Registration Number
- NCT03900949
- Locations
- 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia
- Conditions
- Interventions
- First Posted Date
- 2019-02-11
- Last Posted Date
- 2024-02-22
- Lead Sponsor
- PrECOG, LLC.
- Target Recruit Count
- 181
- Registration Number
- NCT03836209
- Locations
- 🇺🇸
UCLA, Los Angeles, California, United States
🇺🇸University of Rochester Medical Center, Rochester, New York, United States
🇺🇸HonorHealth Research Institute, Scottsdale, Arizona, United States
HDM201 Added to CT in R/R or Newly Diagnosed AML
- First Posted Date
- 2018-11-30
- Last Posted Date
- 2020-01-09
- Lead Sponsor
- Novartis Pharmaceuticals
- Registration Number
- NCT03760445
Midostaurin Associated With Standard Chemotherapy in Patients With Core-binding Factor Leukemia
- Conditions
- Interventions
- First Posted Date
- 2018-09-26
- Last Posted Date
- 2023-11-09
- Lead Sponsor
- Niguarda Hospital
- Target Recruit Count
- 39
- Registration Number
- NCT03686345
- Locations
- 🇮🇹
Ospedale CÃ Granda - Niguarda S.C: Ematologia, Milano, Italy
A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML
- Conditions
- Interventions
- First Posted Date
- 2018-07-19
- Last Posted Date
- 2024-04-05
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 23
- Registration Number
- NCT03591510
- Locations
- 🇹🇷
Novartis Investigative Site, Istanbul, Turkey
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)
- Conditions
- Interventions
- First Posted Date
- 2018-04-30
- Last Posted Date
- 2023-08-21
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 511
- Registration Number
- NCT03512197
- Locations
- 🇺🇸
University of Chicago Medical Center ., Chicago, Illinois, United States
🇺🇸Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Oregon Health and Science Univ, Portland, Oregon, United States
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.
- First Posted Date
- 2017-12-20
- Last Posted Date
- 2024-02-29
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 301
- Registration Number
- NCT03379727
- Locations
- 🇸🇪
Novartis Investigative Site, Uppsala, Sweden
A Study of Midostaurin Efficacy and Safety in Newly Diagnosed Patients With FLT3-mutated AML
- First Posted Date
- 2017-09-12
- Last Posted Date
- 2023-04-19
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 75
- Registration Number
- NCT03280030
- Locations
- 🇻🇳
Novartis Investigative Site, Hanoi, Vietnam
Study of Crenolanib vs Midostaurin Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed FLT3 Mutated AML
- Conditions
- Interventions
- First Posted Date
- 2017-08-23
- Last Posted Date
- 2020-05-22
- Lead Sponsor
- Arog Pharmaceuticals, Inc.
- Target Recruit Count
- 510
- Registration Number
- NCT03258931
- Locations
- 🇺🇸
John Theurer Cancer Center at Hackensack UMC, Hackensack, New Jersey, United States
🇺🇸Cornell University, New York, New York, United States
🇺🇸Oregon Health and Science University, Portland, Oregon, United States
iCare4: Genomic Signatures With Midostaurin in Acute Myeloid Leukemia (UF-HEM-004)
- First Posted Date
- 2017-07-02
- Last Posted Date
- 2018-10-22
- Lead Sponsor
- University of Florida
- Registration Number
- NCT03207334
- Locations
- 🇺🇸
University of Florida, Gainesville, Florida, United States
Drug Development Updates
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