Missing content? – Request curation!
Request curation for specific Genes, variants, or PubMed publications.
Have questions, comments or suggestions? - Let us know!
Email us at : ckbsupport@jax.org
Profile Name | FGFR1 fusion |
Gene Variant Detail | |
Relevant Treatment Approaches |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
FGFR1 rearrange | leukemia | sensitive | AZD4547 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, AZD4547 inhibited survival of leukemia cells harboring FGFR1 translocation in culture and in cell line xenograft models (PMID: 27550940). | 27550940 |
FGFR1 rearrange | myeloid and lymphoid neoplasms associated with FGFR1 abnormalities | sensitive | Ponatinib | Guideline | Actionable | Iclusig (ponatinib) is included in guidelines for patients with a myeloid/lymphoid neoplasm with eosinophilia harboring an FGFR1 rearrangement (NCCN.org). | detail... |
FGFR1 rearrange | B-cell acute lymphoblastic leukemia | not applicable | N/A | Guideline | Prognostic | FGFR1 rearrangements are associated with a poor prognosis in patients with B-cell acute lymphoblastic leukemia (NCCN.org). | detail... |
FGFR1 rearrange | myeloid and lymphoid neoplasms associated with FGFR1 abnormalities | sensitive | Pemigatinib | Guideline | Actionable | Pemazyre (pemigatinib) is included in guidelines (category 2B) for patients with a myeloid/lymphoid neoplasm with eosinophilia harboring an FGFR1 rearrangement (NCCN.org). | detail... |
FGFR1 rearrange | childhood B-cell acute lymphoblastic leukemia | not applicable | N/A | Guideline | Prognostic | FGFR1 rearrangements are associated with a poor prognosis in pediatric patients with B-cell acute lymphoblastic leukemia (NCCN.org). | detail... |
FGFR1 rearrange | lung small cell carcinoma | sensitive | AZD4547 | Preclinical - Cell culture | Actionable | In a preclinical study, AZD4547 inhibited survival of small cell lung cancer cells harboring FGFR1 translocation in culture (PMID: 27550940). | 27550940 |
FGFR1 rearrange | myeloid and lymphoid neoplasms associated with FGFR1 abnormalities | sensitive | Midostaurin | Guideline | Actionable | Rydapt (midostaurin) is included in guidelines for patients with a myeloid/lymphoid neoplasm with eosinophilia harboring an FGFR1 rearrangement (NCCN.org). | detail... |
FGFR1 rearrange | myeloproliferative neoplasm | sensitive | Dovitinib | Preclinical | Actionable | In a preclinical study, primary cells from 8p11 myeloproliferative syndrome patients harboring FGFR1 rearrangement were sensitive to Dovitinib (TKI258)-induced growth inhibition in culture (PMID: 17698633). | 17698633 |
FGFR1 mutant | Advanced Solid Tumor | predicted - sensitive | Debio 1347 | Phase I | Actionable | In a Phase I trial, Debio 1347 treatment resulted in partial response in 10.5% (6/57) and stable disease in 28.1% (16/57) of patients with advanced solid tumors harboring genomic alterations of FGFR1/2/3, including amplifications, fusions, and mutations (PMID: 30745300; NCT01948297). | 30745300 |
FGFR1 mutant | transitional cell carcinoma | predicted - sensitive | Erdafitinib | Phase II | Actionable | In a Phase II trial, Balversa (erdafitinib) treatment resulted in an objective response rate of 42% (40/96, 3 complete response, 37 partial response) and a disease control rate of 80% in patients with metastatic or unresectable urothelial carcinoma harboring FGFR alterations (J Clin Oncol 36, 2018 (suppl; abstr 4503); NCT02365597). | detail... |
FGFR1 mutant | Advanced Solid Tumor | sensitive | Pemigatinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, a variety of cancer cell lines harboring mutations in FGFR1, FGFR2, and/or FGFR3 demonstrated sensitivity to Pemazyre (pemigatinib) in culture and in cell line xenograft models, resulting in inhibition of tumor growth (Cancer Res 2015;75(15 Suppl):Abstract nr 771). | detail... |
FGFR1 mutant | Advanced Solid Tumor | predicted - sensitive | ICP-192 | Phase I | Actionable | In a Phase I trial, ICP-192 (gunagratinib) was well-tolerated, and resulted in an overall response rate or 33.3% (4/12, 1 complete response, 3 partial response) and a disease control rate of 91.7% (11/12) in patients with advanced solid tumors harboring FGF/FGFR gene aberrations (J Clin Oncol 39, 2021 (suppl 15; abstr 4092); NCT03758664). | detail... |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT04045613 | Phase Ib/II | Derazantinib Atezolizumab + Derazantinib | Derazantinib and Atezolizumab in Patients With Urothelial Cancer (FIDES-02) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | CAN | AUT | 7 |
NCT05267106 | Phase II | Pemigatinib | Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System Tumors Harboring Activating FGFR1-3 Alterations (FIGHT-209) | Recruiting | USA | ITA | FRA | ESP | DEU | 4 |
NCT03822117 | Phase II | Pemigatinib | Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207) | Terminated | USA | ITA | FRA | ESP | DEU | 6 |
NCT02608125 | Phase I | PRN1371 | A Dose Escalation Study in Solid Tumors and a Dose Expansion Study of PRN1371 in Adult Patients With Metastatic Urothelial Carcinoma | Terminated | USA | ESP | 0 |
NCT02872714 | Phase II | Pemigatinib | A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Urothelial Carcinoma - (FIGHT-201) | Completed | USA | ITA | FRA | ESP | DEU | BEL | 5 |
NCT04172675 | Phase II | Erdafitinib Gemcitabine Mitomycin C | A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) | Recruiting | USA | ITA | FRA | ESP | DEU | BEL | 11 |
NCT02465060 | Phase II | Erdafitinib Trametinib Crizotinib Sapanisertib AZD4547 Dasatinib Osimertinib Palbociclib Capivasertib Larotrectinib Ulixertinib Nivolumab + Relatlimab Copanlisib Sunitinib Nivolumab Pertuzumab + Trastuzumab Ipatasertib Dabrafenib + Trametinib Binimetinib Adavosertib Afatinib Defactinib GSK2636771 Vismodegib Ado-trastuzumab emtansine Taselisib | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) | Recruiting | USA | 2 |
NCT05253807 | Phase II | Pemigatinib | Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Relapsed or Refractory Advanced Non-Small Cell Lung Cancer With an FGFR Alteration (FIGHT-210) | Recruiting | USA | ITA | FRA | ESP | DEU | 0 |
NCT04083976 | Phase II | Erdafitinib | A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 9 |
NCT02272998 | Phase II | Ponatinib | Ponatinib for Patients Whose Advanced Solid Tumor Cancer Has Activating Mutations Involving the Following Genes: FGFR1, FGFR2, FGFR3, FGFR4, RET, KIT. | Unknown status | USA | 0 |
NCT04601857 | Phase II | Futibatinib + Pembrolizumab | Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma | Recruiting | USA | FRA | ESP | 0 |
NCT01948297 | Phase I | Debio 1347 | Debio 1347-101 Phase I Trial in Advanced Solid Tumours With Fibroblast Growth Factor Receptor (FGFR) Alterations | Terminated | USA | ESP | 3 |
NCT02546661 | Phase I | AZD9150 + Durvalumab Durvalumab + Selumetinib AZD4547 Durvalumab + Olaparib Durvalumab AZD4547 + Durvalumab Durvalumab + Vistusertib Adavosertib + Durvalumab | Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer (BISCAY) | Active, not recruiting | USA | FRA | ESP | CAN | 1 |
NCT04233567 | Phase II | Infigratinib | Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations | Recruiting | USA | 0 |
NCT05216120 | Phase II | Pemigatinib | Pemigatinib in Subjects With Adenosquamous Carcinoma of the Pancreas | Recruiting | USA | 0 |
NCT05316155 | Phase I | Erdafitinib | Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer | Recruiting | USA | FRA | ESP | DEU | 2 |
NCT02393248 | Phase Ib/II | Cisplatin + Gemcitabine + Pemigatinib Docetaxel + Pemigatinib Pemigatinib + Retifanlimab Pemigatinib + Trastuzumab Epacadostat + Pembrolizumab | Open-Label, Dose-Escalation Study of Pemigatinib in Subjects With Advanced Malignancies - (FIGHT-101) | Completed | USA | 1 |
NCT02052778 | Phase Ib/II | Futibatinib | A Study of TAS-120 in Patients With Advanced Solid Tumors | Active, not recruiting | USA | ITA | FRA | ESP | DEU | CAN | 7 |
NCT04088188 | Phase I | Cisplatin + Gemcitabine + Pemigatinib Cisplatin + Gemcitabine + Ivosidenib | Gemcitabine and Cisplatin With Ivosidenib or Pemigatinib for the Treatment of Unresectable or Metastatic Cholangiocarcinoma | Recruiting | USA | 0 |
NCT03834220 | Phase II | Debio 1347 | Basket Trial in Solid Tumors Harboring a Fusion of FGFR1, FGFR2 or FGFR3- (FUZE Clinical Trial) | Terminated | USA | FRA | ESP | AUT | 19 |
NCT02160041 | Phase II | Infigratinib | BGJ398 for Patients With Tumors With FGFR Genetic Alterations | Terminated | USA | 0 |