A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors
NCT ID: NCT04775485
Last Updated: 2025-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
141 participants
INTERVENTIONAL
2021-04-22
2027-05-31
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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Arm 1: Low-Grade Glioma
Participants with recurrent or progressive low-grade glioma will receive 420 milligrams/meters square (mg/m\^2) of tovorafenib weekly according to dose rounding guidelines and according to their baseline body surface area (BSA).
Tovorafenib
Tovorafenib is an oral Type II RAF kinase inhibitor available in 100 mg immediate-release tablet or 25 mg/milliliter (mL) powder for reconstitution.
Arm 2: Low-Grade Glioma Expanded Access
Participants with recurrent or progressive low-grade glioma will receive 420 mg/m\^2 of tovorafenib weekly according to dose rounding guidelines and according to their baseline BSA.
Tovorafenib
Tovorafenib is an oral Type II RAF kinase inhibitor available in 100 mg immediate-release tablet or 25 mg/milliliter (mL) powder for reconstitution.
Arm 3: Advanced Solid Tumor
Participants with advanced solid tumors will receive 420 mg/m\^2) of tovorafenib weekly according to dose rounding guidelines and according to their baseline BSA.
Tovorafenib
Tovorafenib is an oral Type II RAF kinase inhibitor available in 100 mg immediate-release tablet or 25 mg/milliliter (mL) powder for reconstitution.
Interventions
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Tovorafenib
Tovorafenib is an oral Type II RAF kinase inhibitor available in 100 mg immediate-release tablet or 25 mg/milliliter (mL) powder for reconstitution.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Advanced Solid Tumor: locally advanced or metastatic solid tumor with documented known or expected to be activating RAF fusion.
* Participants must have histopathologic verification of malignancy at either original diagnosis or relapse.
* Must have received at least one line of prior systemic therapy and have documented evidence of radiographic progression.
* Must have at least 1 measurable lesion as defined by RANO (Arms 1 \& 2) or RECIST v1.1 (Arm 3) criteria
Exclusion Criteria
* Participant has symptoms of without radiographically recurrent or radiographically progressive disease.
* Known or suspected diagnosis of neurofibromatosis type 1 (NF-1) via genetic testing or current diagnostic criteria.
6 Months
25 Years
ALL
No
Sponsors
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Pacific Pediatric Neuro-Oncology Consortium
OTHER
Day One Biopharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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UCSF Benioff Children's Hospital
San Francisco, California, United States
Children's National Medical Center
Washington D.C., District of Columbia, United States
Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
CS Mott Children's Hospital
Ann Arbor, Michigan, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
NYU Langone Health
New York, New York, United States
Duke Cancer Center
Durham, North Carolina, United States
Doernbecher Children's Hospital Oregon & Health Science University
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Texas Children's Hospital
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Seattle Children's Hospital
Seattle, Washington, United States
Queensland Children's Hospital
Brisbane, , Australia
Royal Children's Hospital
Parkville, , Australia
Perth Children's Hospital
Perth, , Australia
Sydney Children's Hospital
Randwick, , Australia
The Children's Hospital at Westmead
Westmead, , Australia
Centre Hospitalier Universitaire Ste-Justine
Montreal, Quebec, Canada
Montreal Children's Hospital
Montreal, Quebec, Canada
Centre Mère-Enfant Soleil du CHU
Québec, Quebec, Canada
Rigshospitalet
Copenhagen, , Denmark
Charité Universitätsmedizin Berlin, Campus Virchow Klinikum, Otto-Heubner-Centrum für Kinder
Berlin, , Germany
Hopp-Kindertumorzentrum Heidelberg (KiTZ), KiTZ Clinical Trial Unit (ZIPO)
Heidelberg, , Germany
Rambam Health Care Campus
Haifa, , Israel
Schneider Children's Medical Center of Israel
Petah Tikva, , Israel
The Chaim Sheba Medical Center
Ramat Gan, , Israel
Princess Maxima Center for Pediatric Oncology
Utrecht, , Netherlands
KK Women's and Children's Hospital
Singapore, , Singapore
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital - Yonsei University
Seoul, , South Korea
Universitäts-Kinderspital Zürich - Eleonorenstiftung
Zurich, , Switzerland
UCL Great Ormond Street Institute of Child Health
London, , United Kingdom
Newcastle University
Newcastle upon Tyne, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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References
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Kilburn LB, Khuong-Quang DA, Hansford JR, Landi D, van der Lugt J, Leary SES, Driever PH, Bailey S, Perreault S, McCowage G, Waanders AJ, Ziegler DS, Witt O, Baxter PA, Kang HJ, Hassall TE, Han JW, Hargrave D, Franson AT, Yalon Oren M, Toledano H, Larouche V, Kline C, Abdelbaki MS, Jabado N, Gottardo NG, Gerber NU, Whipple NS, Segal D, Chi SN, Oren L, Tan EEK, Mueller S, Cornelio I, McLeod L, Zhao X, Walter A, Da Costa D, Manley P, Blackman SC, Packer RJ, Nysom K. The type II RAF inhibitor tovorafenib in relapsed/refractory pediatric low-grade glioma: the phase 2 FIREFLY-1 trial. Nat Med. 2024 Jan;30(1):207-217. doi: 10.1038/s41591-023-02668-y. Epub 2023 Nov 17.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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DAY101-001/PNOC026
Identifier Type: -
Identifier Source: org_study_id
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