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
- -
Revumenib in Combination With 7+3 + Midostaurin in AML
- Conditions
- Interventions
- First Posted Date
- 2024-03-15
- Last Posted Date
- 2024-03-21
- Lead Sponsor
- Maximilian Stahl, MD
- Target Recruit Count
- 22
- Registration Number
- NCT06313437
- Locations
- 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸Brigham and Women's Hospital, Boston, Massachusetts, United States
Healthcare Resource Utilization in Adults Diagnosed With Acute Myeloid Leukemia (AML)
- First Posted Date
- 2022-08-04
- Last Posted Date
- 2022-11-08
- Lead Sponsor
- Novartis Pharmaceuticals
- Target Recruit Count
- 81
- Registration Number
- NCT05488613
- Locations
- 🇫🇮
Novartis Investigative Site, Helsinki, Finland
Managed Access Programs for PKC412, Midostaurin
- First Posted Date
- 2022-02-02
- Last Posted Date
- 2024-06-28
- Lead Sponsor
- Novartis Pharmaceuticals
- Registration Number
- NCT05219266
Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia
- First Posted Date
- 2021-07-29
- Last Posted Date
- 2024-10-01
- Lead Sponsor
- Guenther Koehne
- Target Recruit Count
- 20
- Registration Number
- NCT04982354
- Locations
- 🇺🇸
Miami Cancer Institute at Baptist Health of South Florida, Miami, Florida, United States
HDM201 and Midostaurin (HDMM) in Relapsed/Refractory AML With FLT3mut and TP53wt.
- First Posted Date
- 2020-08-04
- Last Posted Date
- 2022-10-06
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- Target Recruit Count
- 2
- Registration Number
- NCT04496999
- Locations
- 🇨🇭
Departement of Medical Oncology, University Hospital Berne, Berne, Switzerland
AML Patients Bearing FLT3 Mutations Based on Peripheral Blast Clearance
- Conditions
- Interventions
- First Posted Date
- 2019-11-22
- Last Posted Date
- 2022-03-02
- Target Recruit Count
- 172
- Registration Number
- NCT04174612
- Locations
- 🇮🇹
Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia, Orbassano, Italy
🇮🇹Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia, Mestre, Italy
🇮🇹Aou Policlinico P. Giaccone - Palermo - Uo Ematologia, Palermo, Italy
Tolerability and Efficacy of Midostaurin to 10-day Decitabine in Unfit Adult AML and High Risk MDS Patients
- First Posted Date
- 2019-09-20
- Last Posted Date
- 2023-01-06
- Target Recruit Count
- 140
- Registration Number
- NCT04097470
- Locations
- 🇧🇪
BE-Haine-Saint-Paul-JOLIMONT, Haine-Saint-Paul, Belgium
🇨🇭CH-Bellinzona-IOSI, Bellinzona, Switzerland
🇧🇪BE-Antwerpen-ZNASTUIVENBERG, Antwerpen, Belgium
A Phase 1b Master Trial to Investigate CPX-351 in Subjects With Previously Untreated Acute Myeloid Leukemia
- Conditions
- Interventions
- First Posted Date
- 2019-09-03
- Last Posted Date
- 2023-10-16
- Lead Sponsor
- Jazz Pharmaceuticals
- Target Recruit Count
- 57
- Registration Number
- NCT04075747
- Locations
- 🇺🇸
University of Kansas Cancer Center, Fairway, Kansas, United States
🇺🇸University of Nebraska Medical Center, Omaha, Nebraska, United States
🇺🇸Hackensack University Medical Center, Hackensack, New Jersey, United States
A Study of Gilteritinib Versus Midostaurin in Combination With Induction and Consolidation Therapy Followed by One-year Maintenance in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndromes With Excess Blasts-2 With FLT3 Mutations Eligible for Intensive Chemotherapy
- Conditions
- Interventions
- First Posted Date
- 2019-07-19
- Last Posted Date
- 2024-12-17
- Target Recruit Count
- 777
- Registration Number
- NCT04027309
- Locations
- 🇦🇺
AU-Adelaide-FLINDERS, Adelaide, Australia
🇦🇺AU-Adelaide-RAH, Adelaide, Australia
🇦🇺AU-Brisbane-PAH, Brisbane, Australia
Midostaurin in MRD (Minimal Residual Disease) Positive Acute Myeloid Leukemia After Allogeneic Stem Cell Transplantation
- First Posted Date
- 2019-05-16
- Last Posted Date
- 2022-01-21
- Lead Sponsor
- University of Jena
- Target Recruit Count
- 1
- Registration Number
- NCT03951961
- Locations
- 🇩🇪
Klinikum Chemnitz gGmbH, Chemnitz, Germany
🇩🇪Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Dresden, Germany
🇩🇪Universitätsklinikum Jena, Jena, Germany
Drug Development Updates
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