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)

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

and more 503 locations

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

and more 41 locations

Standard of Care +/- Midostaurin to Prevent Relapse Post Stem Cell Transplant in Patients With FLT3-ITD Mutated AML

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

and more 16 locations

Protocol in Acute Myeloid Leukemia With FLT3-ITD

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

and more 52 locations

PK and Safety of Midostaurin in Subjects With Impaired Hepatic Function and Subjects With Normal Hepatic Function

Phase 1
Completed
Conditions
Interventions
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

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