Tovorafenib
- Generic Name
- Tovorafenib
- Drug Type
- Small Molecule
- Chemical Formula
- C17H12Cl2F3N7O2S
- CAS Number
- 1096708-71-2
- Unique Ingredient Identifier
- ZN90E4027M
- Background
Tovorafenib (TAK-580) is under investigation in clinical trial NCT02723006 (Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Participants With Advanced Melanoma).
Study for Patients With Hairy Cell Leukemia to Test the Targeted Agent Tovorafenib in Combination With Rituximab and Compare the Combination With Current Standard Treatment
- Conditions
- Hairy Cell LeukemiaRecurrent Hairy Cell LeukemiaRefractory Hairy Cell Leukemia
- Interventions
- Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyProcedure: Computed Tomography
- First Posted Date
- 2025-05-11
- Last Posted Date
- 2025-05-11
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 78
- Registration Number
- NCT06965114
Pilot Study of Vinblastine and Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Gliomas
- First Posted Date
- 2024-04-24
- Last Posted Date
- 2025-05-15
- Lead Sponsor
- Daniel Morgenstern
- Target Recruit Count
- 57
- Registration Number
- NCT06381570
- Locations
- 🇨🇦
The Hospital for Sick Children, Toronto, Ontario, Canada
A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis
- Conditions
- Recurrent Langerhans Cell HistiocytosisRefractory Langerhans Cell Histiocytosis
- Interventions
- Procedure: Biospecimen CollectionProcedure: Bone Marrow AspirationProcedure: Bone Marrow BiopsyProcedure: Computed TomographyProcedure: Echocardiography TestProcedure: FDG-Positron Emission Tomography and Computed Tomography ScanProcedure: Lumbar PunctureProcedure: Multigated Acquisition Scan
- First Posted Date
- 2023-04-25
- Last Posted Date
- 2025-05-20
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 48
- Registration Number
- NCT05828069
- Locations
- 🇺🇸
Children's Hospital of Alabama, Birmingham, Alabama, United States
🇺🇸Arkansas Children's Hospital, Little Rock, Arkansas, United States
🇺🇸Kaiser Permanente Downey Medical Center, Downey, California, United States
Expanded Access Program (EAP) for Tovorafenib (DAY101) in RAF-Altered, Relapsed or Refractory Low-Grade Glioma
- Conditions
- Low-grade Glioma
- First Posted Date
- 2023-03-08
- Last Posted Date
- 2024-08-12
- Lead Sponsor
- Day One Biopharmaceuticals, Inc.
- Registration Number
- NCT05760586
DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
- Conditions
- Low-grade GliomaPediatric Low-grade GliomaRapidly Accelerated Fibrosarcoma (RAF) Altered Glioma
- Interventions
- Drug: Chemotherapeutic Agent
- First Posted Date
- 2022-10-04
- Last Posted Date
- 2025-05-08
- Lead Sponsor
- Day One Biopharmaceuticals, Inc.
- Target Recruit Count
- 400
- Registration Number
- NCT05566795
- Locations
- 🇦🇺
Perth Children's Hospital, Nedlands, Australia
🇦🇺Women's and Children's Health Network, North Adelaide, Australia
🇦🇺The Royal Children's Hospital - Children's Cancer Centre, Parkville, Australia
Nivolumab and Tovorafenib for Treatment of Craniopharyngioma in Children and Young Adults
- Conditions
- Recurrent CraniopharyngiomaCraniopharyngioma, ChildCraniopharyngioma
- Interventions
- First Posted Date
- 2022-07-19
- Last Posted Date
- 2024-12-19
- Lead Sponsor
- Sabine Mueller, MD, PhD
- Target Recruit Count
- 56
- Registration Number
- NCT05465174
- Locations
- 🇺🇸
University of Michigan, Ann Arbor, Michigan, United States
🇺🇸University of Alabama at Birmingham, Birmingham, Alabama, United States
🇺🇸Rady Children's Hospital/University of California, San Diego, San Diego, California, United States
Tovorafenib (DAY101) Monotherapy or in Combination With Other Therapies for Patients With Melanoma and Other Solid Tumors
- Conditions
- MelanomaSolid TumorCRAF Gene AmplificationSpitzoid MelanomaPilocytic AstrocytomaPilocytic Astrocytoma, AdultNon Small Cell Lung CancerNon-Small Cell AdenocarcinomaColorectal CancerPancreatic Acinar Carcinoma
- Interventions
- First Posted Date
- 2021-08-02
- Last Posted Date
- 2024-03-29
- Lead Sponsor
- Day One Biopharmaceuticals, Inc.
- Target Recruit Count
- 168
- Registration Number
- NCT04985604
- Locations
- 🇺🇸
The Angeles Clinic, Los Angeles, California, United States
🇺🇸Hoag Health, Newport Beach, California, United States
🇺🇸University of Colorado Hospital, Aurora, Colorado, United States
A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors
- First Posted Date
- 2021-03-01
- Last Posted Date
- 2025-04-10
- Lead Sponsor
- Day One Biopharmaceuticals, Inc.
- Target Recruit Count
- 141
- Registration Number
- NCT04775485
- Locations
- 🇨🇦
Montreal Children's Hospital, Montreal, Quebec, Canada
🇺🇸University of Utah, Salt Lake City, Utah, United States
🇦🇺Sydney Children's Hospital, Randwick, Australia
DAY101 In Gliomas and Other Tumors
- First Posted Date
- 2018-02-12
- Last Posted Date
- 2025-02-03
- Lead Sponsor
- Karen D. Wright, MD
- Target Recruit Count
- 44
- Registration Number
- NCT03429803
- Locations
- 🇺🇸
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States
🇺🇸Children's Hospital Los Angeles, Los Angeles, California, United States
🇺🇸Massacusetts General Hospital, Boston, Massachusetts, United States
Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Participants With Advanced Melanoma
- Conditions
- Melanoma
- Interventions
- First Posted Date
- 2016-03-30
- Last Posted Date
- 2024-03-05
- Lead Sponsor
- Millennium Pharmaceuticals, Inc.
- Target Recruit Count
- 22
- Registration Number
- NCT02723006
- Locations
- 🇺🇸
Emory University Hospital, Atlanta, Georgia, United States
🇺🇸Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
🇺🇸Texas Oncology-Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Drug Development Updates
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