A Study to Evaluate DAY101 in Pediatric and Young Adult Patients With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors
Advanced Solid Tumor | Low-grade GliomaFIREFLY-1 is an ongoing, Phase 2, multi center, open-label study to evaluate the safety and efficacy of oral pan-RAF inhibitor DAY101 in pediatric, adolescent, and young adult patients with recurrent or progressive low-grade glioma or an advanced solid tumor harboring a known RAF alteration.
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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
1 to 25
Critères de participation
Inclusion Criteria:
* Age 6 months to 25 years with:
1. Arms 1 \& 2: a relapsed or progressive LGG with documented known activating BRAF alteration
2. Arm 3: locally advanced or metastatic solid tumor with documented known or expected to be activating RAF fusion
* Confirmation of histopathologic diagnosis of LGG and molecular diagnosis of activating BRAF alteration
* Must have received at least one line of systemic therapy and have 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:
* Patient's tumor has additional previously-known activating molecular alterations
* Patient has symptoms of clinical progression in the absence of radiographic progression
* Known or suspected diagnosis of neurofibromatosis type 1 (NF-1)
* Other inclusion/exclusion criteria as stipulated by protocol may apply
Lieu de l'étude
Centre Mère-Enfant Soleil du CHU
Centre Mère-Enfant Soleil du CHUQuébec, Quebec
Canada
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Centre Hospitalier Universitaire Ste-Justine
Centre Hospitalier Universitaire Ste-JustineMontreal, Quebec
Canada
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Montreal Children's Hospital
Montreal Children's HospitalMontreal, Quebec
Canada
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- Étude parrainée par
- Day One Biopharmaceuticals, Inc.
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT04775485