Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors
NCT ID: NCT04985604
Last Updated: 2025-10-02
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
23 participants
INTERVENTIONAL
2021-07-15
2024-07-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Melanoma Cohort
Tovorafenib monotherapy
Tovorafenib
Tovorafenib tablet for oral use.
Tissue Agnostic Cohort
Tovorafenib monotherapy
Tovorafenib
Tovorafenib tablet for oral use.
Interventions
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Tovorafenib
Tovorafenib tablet for oral use.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants must have a histologically confirmed diagnosis of melanoma or other solid tumor and a BRAF fusion, CRAF/RAF1 fusion, or CRAF/RAF1 amplifications obtained through a tumor or liquid biopsy as assessed by genomic sequencing, polymerase chain reaction (PCR), fluorescence in situ hybridization (FISH), or another clinically accepted molecular diagnostic method recognized by local laboratory or regulatory agency.
* Participants must have radiographically-recurrent or radiographically-progressive disease that is measurable using the appropriate tumor response criteria (e.g. RECIST version 1.1 or RANO).
* Archival tumor tissue (preferably less than 3 years old) or fresh tumor tissue for correlative studies is required
* If brain metastases are present, they must have been previously treated and be stable as assessed by radiographic imaging
Exclusion Criteria
* Known presence of concurrent activating mutation
* Participants with current evidence or a history of central serous retinopathy (CSR), retinal vein occlusion (RVO)
12 Years
ALL
No
Sponsors
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Day One Biopharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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The Angeles Clinic
Los Angeles, California, United States
Hoag Health
Newport Beach, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Cancer Specialists of North Florida
Jacksonville, Florida, United States
Community North Cancer Center
Indianapolis, Indiana, United States
OHSU Knight Cancer Institute
Portland, Oregon, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Monash Medical Centre
Clayton, Victoria, Australia
Antwerp University Hospital
Edegem, , Belgium
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Hopital de La Timone - APHM
Marseille, Bouches-du-Rhône, France
Dong-A University Hospital
Busan, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Hospital Clinic Barcelona
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol: Sub-protocol DAY102-102a
Document Type: Study Protocol: Umbrella (Master) Protocol- DAY102-102
Document Type: Statistical Analysis Plan
Other Identifiers
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2021-003768-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DAY101-102a
Identifier Type: -
Identifier Source: org_study_id
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