Table 1.
Clinical Trials Involving FGFR Targeted Therapy in BTC
| Drugs | ClinicalTrials.gov Identifier | Status | Phase | Disease | Number of Patients | Design |
|---|---|---|---|---|---|---|
| BGJ398 (Infigratinib) | NCT02150967 | Recruiting | II | CCA with FGFR2 mutation | 160 | BGJ398 |
| NCT03773302 | Recruiting | III | CCA with FGFR2 mutation | 384 | BGJ398 vs GEMCIS | |
| NCT04233567 | Recruiting | II | CCA with FGFR2 fusion | 50 | BGJ398 | |
| ARQ087 (Derazantinib) | NCT01752920 | Completed | II | iCCA with FGFR2 fusion, Other solid tumor types with FGFR alterations | 119 | ARQ087 |
| NCT03230318 | Recruiting | II | iCCA, Combined hepatocellular and CCA | 143 | ARQ087 | |
| TAS-120 (Futibatinib) | NCT04093362 | Not yet recruiting | III | CCA with FGFR2 rearrangements | 216 | TAS-120 vs GEMCIS |
| NCT02052778 | Recruiting | I II |
CCA, Other solid tumor types with FGFR2 gene fusions | 371 | TAS-120 | |
| Pemigatinib (INCB054828) | NCT02924376 | Active, not recruiting | II | CCA | 147 | Pemigatinib |
| NCT03656536 | Recruiting | III | CCA | 432 | Pemigatinib vs GEMCIS | |
| NCT04256980 | Recruiting | II | CCA | 54 | Pemigatinib | |
| NCT04088188 | Not yet recruiting | I | CCA | 40 | Pemigatinib plus GEMCIS vs Ivosidenib plus GEMCIS | |
| NCT02393248 | Recruiting | I II |
CCA, Other solid tumor types | 325 | Pemigatinib plus GEMCIS vs Pemigatinib plus Pembrolizumab vs Pemigatinib plus Docetaxel vs Pemigatinib plus Trastuzumab vs Pemigatinib plus INCMGA00012 | |
| Erdafitinib (JNJ-42756493) | NCT02699606 | Recruiting | II | CCA, Other solid tumor types | 63 | Erdafitinib |
| Pazopanib | NCT01855724 | Terminated | II | BTC | 29 | Pazopanib plus Gemcitabine |
| NCT01438554 | Completed | I | CCA Thyroid Cancer Soft-tissue Sarcoma | 89 | Pazopanib plus GSK1120212 | |
| Ponatinib | NCT02265341 | Completed | II | BTC | 12 | Ponatinib |
| Dovitinib | NCT01497392 | Completed | I | BTC Pancreatic Cancer | 26 | Dovitinib plus Gemcitabine plus Capecitabine |