Condition: Low-grade Glioma · Sponsor: Daniel Morgenstern
This is a Pilot, multicenter, open-label study of patients less than or equal to 25 years, with recurrent or progressive LGG harboring a CRAF or BRAF alteration, including BRAF V600 mutations and KIAA1549: BRAF fusions. Patients with BRAF or CRAF alterations will be identified through molecular assays as routinely performed at Clinical Laboratory Improvement Amendments (CLIA) of 1988 or other similarly certified laboratories. The study will be conducted in two sequential phases: Phase A: A Feasibility (combination dose finding) phase, followed by Phase B: An Efficacy phase. The maximum tolerated dose (MTD)/Recommended Phase 2 Dose (RP2D) of the combination as determined in Phase A would be the dose used in Phase B. The patients on Phase A who were below the MTD/RP2D would be eligible for intra-patient dose escalation to MTD/RP2D subject to criteria outlined later
This description comes directly from the study's public registry record.
Nirav Thacker · 613-737-7600 · nthacker@cheo.on.ca
Aiman Siddiqi · aiman.siddiqi@sickkids.ca
Always discuss trial participation with your own doctor first.
| The Hospital for Sick Children | Toronto, Ontario, Canada | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06381570