Active trials, both recruiting and not recruiting, with FGFR’s inhibitors described above
NCT | Phase | Status | Tumors | Line of treatment | Target | Experimental treatment | Standard treatment | Primary endpoints | Sponsor |
---|---|---|---|---|---|---|---|---|---|
NCT03656536 | 3 | Recruiting | CCA | 1 L | FGFR2 rearrangement | Pemigatinib | Gem-Cis | PFS | Profit |
NCT03773302 | 3 | Recruiting | CCA | 1 L | FGFR2 fusions/translocations | Infigratinib | Gem-Cis | PFS | Profit |
NCT04093362 | 3 | Recruiting | iCCA | 1 L | FGFR2 rearrangement | Futibatinib | Gem-Cis | PFS | Profit |
NCT04256980 | 2 | Active, not recruiting | CCA | 2 L | FGFR2 rearrangement | Pemigatinib | N.A. | ORR | Profit |
NCT04083976 | 2 | Recruiting | CCA | ≥ 2 L | FGFR mutations/fusions | Erdafitinib | N.A. | ORR | Profit |
NCT03230318 | 2 | Recruiting | iCCA | 2 L | FGFR2 fusion, mutation or amplification | Derazantinib | N.A. | ORR | Profit |
NCT04233567 | 2 | Recruiting | CCA | ≥ 2 L | FGFR fusions, translocations or activating mutations | Infigratinib | N.A. | ORR | Non-profit |
NCT04238715 | 2 | Recruiting | CCA | 2 L | FGFR2 fusion | E7090 | N.A. | ORR | Profit |
NCT04353375 | 2 | Not yet recruiting | iCCA | 2 L | FGFR2 fusion | HMPL-453 tartrate | N.A. | ORR | Profit |
NCT04565275 | 1/2 | Recruiting | CCA | NTA | FGFR alteration | ICP-192 | N.A. | MTD, ORR, AE, OBD, RP2D | Profit |
NCT03144661 | 1 | Terminated | CCA | NTA | FGF19/FGFR4 | INCB062079 | N.A. | Safety | Profit |
NCT04149691 | 1 | Recruiting | CCA | NTA | FGFR 1, 2, 3 alteration | CPL304110 | N.A. | MTD, safety | Profit |
NCT03583125 | 1 | Recruiting | CCA | NTA | FGFR alteration | EOC317 | N.A. | DLT | Profit |
NCT04526106 | 1 | Recruiting | CCA | NTA | FGFR2 fusion, mutation, or amplification | RLY-4008 | N.A. | MTD, AE | Profit |
A “withdrawn” trial was excluded, stopped early because of a slow accrual (NCT04479904). AE: adverse event; DLT: dose-limiting toxicity; MTD: maximum tolerated dose; NTA: no treatment available; OBD: optimal biological dose; PFS: progression-free survival; RP2D: recommended phase 2 dose; L: chemotherapy line; N.A.: not applicable
MDM, DM, ES contributed conception and design of the review; AC, TG, FDV organized the database; GA, CP, CZ wrote the first draft of the manuscript. All authors contributed to manuscript revision, read and approved the submitted version.
The authors declare the following financial interests/personal relationships that may be considered as potential competing interests: Massimo Di Maio received honoraria and had roles as consultant or advisor for AstraZeneca, Pfizer, Novartis, Roche, Takeda, Eisai, Janssen, Astellas; received institutional research grant by Tesaro e GlaxoSmithKline, outside the submitted work. All remaining authors declared no conflicts of interest.
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© The Author(s) 2021.