CLINICAL TRIALS PROFILE FOR TOVORAFENIB
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All Clinical Trials for tovorafenib
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT05465174 ↗ | Nivolumab and DAY101 for Treatment of Craniopharyngioma in Children and Young Adults | Not yet recruiting | Bristol-Myers Squibb | Phase 2 | 2022-09-01 | The current study assesses the tolerability and efficacy of combination therapy with PD-1 (nivolumab) and pan-RAF-kinase (DAY101) inhibition for the treatment of children and young adults with craniopharyngioma. |
| NCT05465174 ↗ | Nivolumab and DAY101 for Treatment of Craniopharyngioma in Children and Young Adults | Not yet recruiting | Day One Biopharmaceuticals, Inc. | Phase 2 | 2022-09-01 | The current study assesses the tolerability and efficacy of combination therapy with PD-1 (nivolumab) and pan-RAF-kinase (DAY101) inhibition for the treatment of children and young adults with craniopharyngioma. |
| NCT05465174 ↗ | Nivolumab and DAY101 for Treatment of Craniopharyngioma in Children and Young Adults | Not yet recruiting | Sabine Mueller, MD, PhD | Phase 2 | 2022-09-01 | The current study assesses the tolerability and efficacy of combination therapy with PD-1 (nivolumab) and pan-RAF-kinase (DAY101) inhibition for the treatment of children and young adults with craniopharyngioma. |
| NCT05566795 ↗ | DAY101 vs. Standard of Care Chemotherapy in Pediatric Patients With Low-Grade Glioma Requiring First-Line Systemic Therapy | Not yet recruiting | SIOPe Brain Tumor Group LOGGIC Consortium | Phase 3 | 2022-10-01 | This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to evaluate the efficacy, safety, and tolerability of DAY101 monotherapy versus standard of care (SoC) chemotherapy in patients with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring front-line systemic therapy. |
| NCT05566795 ↗ | DAY101 vs. Standard of Care Chemotherapy in Pediatric Patients With Low-Grade Glioma Requiring First-Line Systemic Therapy | Not yet recruiting | Day One Biopharmaceuticals, Inc. | Phase 3 | 2022-10-01 | This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to evaluate the efficacy, safety, and tolerability of DAY101 monotherapy versus standard of care (SoC) chemotherapy in patients with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring front-line systemic therapy. |
| NCT05828069 ↗ | A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis | Recruiting | National Cancer Institute (NCI) | Phase 2 | 2023-04-07 | This phase II trial tests the safety, side effects and best dose of tovorafenib (DAY101) in treating patients with Langerhans cell histiocytosis that are growing, spreading, or getting worse (progressive), has come back (relapsed), or does respond to treatment (refractory). Tovorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and blocks over-active growth pathways in cancer cells. Giving tovorafenib may cause the tumor to stop growing or to shrink for a period of time. |
| NCT06381570 ↗ | Pilot Study of Vinblastine and Tovorafenib in Pediatric Patients With Recurrent/Progressive RAF Altered Low Grade Gliomas | RECRUITING | The Hospital for Sick Children | EARLY_PHASE1 | 2024-03-21 | 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 |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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