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 rearrange |
Gene Variant Detail | |
Relevant Treatment Approaches | FGFR Inhibitor (Pan) |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
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... |
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 | 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 | 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... |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT04294277 | Phase II | Pemigatinib | Safety and Efficacy of Pemigatinib in Patients With High-risk Urothelial Cancer After Radical Surgery (PEGASUS) | Active, not recruiting | ITA | 0 |
NCT03011372 | Phase II | Pemigatinib | A Study to Evaluate the Efficacy and Safety of Pemigatinib (INCB054828) in Subjects With Myeloid/Lymphoid Neoplasms With FGFR1 Rearrangement - (FIGHT-203) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT | 3 |
NCT01975701 | Phase II | Infigratinib | A Phase 2 Study of BGJ398 in Patients With Recurrent GBM | Completed | USA | ESP | BEL | 3 |
NCT02706691 | Phase II | Infigratinib | Pan FGFR Kinase Inhibitor BGJ398 in Treating Patients With FGFR1-3 Translocated, Mutated, or Amplified Recurrent Head and Neck Cancer | Terminated | USA | 0 |
NCT03801434 | Phase II | Ruxolitinib | Ruxolitinib in Treating Patients With Hypereosinophilic Syndrome or Primary Eosinophilic Disorders | 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 |
NCT04233567 | Phase II | Infigratinib | Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations | Recruiting | USA | 0 |
NCT03611868 | Phase Ib/II | APG-115 + Pembrolizumab | A Study of APG-115 in Combination With Pembrolizumab in Patients With Metastatic Melanomas or Advanced Solid Tumors | Recruiting | USA | 1 |
NCT01831726 | Phase II | Dovitinib | Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib | Completed | USA | 0 |
NCT04096417 | Phase II | Pemigatinib | Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations | Active, not recruiting | USA | 0 |
NCT03862157 | Phase Ib/II | Azacitidine + MLN4924 + Venetoclax | Azacitidine, Venetoclax, and Pevonedistat in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia | Active, not recruiting | USA | 0 |
NCT02268253 | Phase II | Tagraxofusp-erzs | Tagraxofusp (SL-401) in Patients With CMML or MF | Recruiting | USA | CAN | 0 |
NCT04189445 | Phase II | Futibatinib | Futibatinib in Patients With Specific FGFR Aberrations | Recruiting | USA | ITA | FRA | ESP | DEU | BEL | 9 |
NCT05216120 | Phase II | Pemigatinib | Pemigatinib in Subjects With Adenosquamous Carcinoma of the Pancreas | Recruiting | USA | 0 |
NCT04003623 | Phase II | Pemigatinib | Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208) | Terminated | USA | 0 |
NCT04923126 | Phase Ib/II | PD-0325901 | SJ901: Evaluation of Mirdametinib in Children, Adolescents, and Young Adults With Low-Grade Glioma | Recruiting | USA | 0 |
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 |
NCT04601857 | Phase II | Futibatinib + Pembrolizumab | Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma | Recruiting | USA | FRA | ESP | 0 |