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Profile Name | FGFR2 N82K |
Gene Variant Detail | |
Relevant Treatment Approaches | FGFR Inhibitor (Pan) FGFR2 Inhibitor |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
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NCT03517956 | Phase I | Copanlisib + Rogaratinib | Phase 1 Study of the Combination of Rogaratinib With Copanlisib in Patients With Fibroblast Growth Factor Receptor (FGFR)-Positive, Locally Advanced or Metastatic Solid Tumors (ROCOCO) | Completed | USA | ESP | DEU | BEL | 2 |
NCT05052801 | Phase III | Bemarituzumab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin | Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (FORTITUDE-101) | Recruiting | USA | ITA | FRA | ESP | CAN | BEL | 20 |
NCT03088059 | Phase II | Niraparib Durvalumab + Monalizumab Methotrexate Carboplatin Rogaratinib Mitomycin C Docetaxel Afatinib Paclitaxel Durvalumab Monalizumab Palbociclib Bleomycin Gemcitabine Fluorouracil | Biomarker-based Study in R/M SCCHN (UPSTREAM) | Recruiting | ITA | FRA | BEL | 1 |
NCT05111626 | Phase I | Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin Bemarituzumab + Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin | Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer (FORTITUDE-102) | Recruiting | USA | 2 |
NCT03694522 | Phase II | Bemarituzumab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin | A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT) | Completed | USA | ITA | FRA | ESP | DEU | BEL | 12 |
NCT01888562 | Phase I | Ponatinib | Ponatinib in the Treatment of FGFR Mutation Positive Recurrent or Persistent Endometrial Carcinoma | Withdrawn | 0 | |
NCT02368951 | Phase I | Aprutumab ixadotin | Phase I, Dose-escalation Trial of BAY1187982 in Subjects With Advanced Solid Tumors Known to Express Fibroblast Growth Factor Receptor 2 (FGFR2) | Terminated | USA | 2 |
NCT04483505 | Phase I | Fulvestrant + Palbociclib + Rogaratinib | Rogaratinib, Palbociclib y Fulvestrant in Patients With Breast Cancer. (ROGABREAST) | Recruiting | ESP | 0 |
NCT03656536 | Phase III | Pemigatinib Cisplatin + Gemcitabine | A Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma - (FIGHT-302) | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT | 11 |
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 |
NCT01831726 | Phase II | Dovitinib | Dovitinib for Patients With Tumor Pathway Activations Inhibited by Dovitinib | Completed | USA | 0 |
NCT04233567 | Phase II | Infigratinib | Infigratinib for the Treatment of Advanced or Metastatic Solid Tumors in Patients With FGFR Gene Mutations | Recruiting | USA | 0 |
NCT04189445 | Phase II | Futibatinib | Futibatinib in Patients With Specific FGFR Aberrations | Recruiting | USA | ITA | FRA | ESP | DEU | BEL | 9 |
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 |
NCT01975701 | Phase II | Infigratinib | A Phase 2 Study of BGJ398 in Patients With Recurrent GBM | Completed | USA | ESP | BEL | 3 |
NCT04601857 | Phase II | Futibatinib + Pembrolizumab | Futibatinib and Pembrolizumab Combination in the Treatment of Advanced or Metastatic Urothelial Carcinoma | Recruiting | USA | FRA | ESP | 0 |
NCT05174650 | Phase II | Atezolizumab + Derazantinib | Treatment of Atezolizumab and Derazantinib in Patients With Advanced iCCA With FGFR2 Fusions/Rearrangements | Recruiting | DEU | 0 |
NCT04093362 | Phase III | Futibatinib Cisplatin + Gemcitabine | Futibatinib Vs Gemcitabine-Cisplatin Chemotherapy as 1st-Line Treatment of Patients With Advanced Cholangiocarcinoma (CCA) Harboring FGFR2 Gene Rearrangements (FOENIX-CCA3) | Recruiting | USA | ITA | FRA | ESP | DEU | BEL | 14 |
NCT05216120 | Phase II | Pemigatinib | Pemigatinib in Subjects With Adenosquamous Carcinoma of the Pancreas | Not yet recruiting | USA | 0 |
NCT04507503 | Expanded access | Futibatinib | Expanded Access Study of TAS-120 in Patients With Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangements | Available | 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 |
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 |
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 |
NCT04096417 | Phase II | Pemigatinib | Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations | Active, not 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 |
NCT04003623 | Phase II | Pemigatinib | Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208) | Terminated | USA | 0 |
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 |
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 |
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 |
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 |
NCT04053322 | Phase II | Durvalumab + Fulvestrant + Olaparib | Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients. (DOLAF) | Recruiting | FRA | 0 |
NCT05316155 | Phase I | Erdafitinib | Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer | Recruiting | USA | FRA | ESP | DEU | 2 |
NCT04963153 | Phase I | Enfortumab vedotin-ejfv + Erdafitinib | Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy | Recruiting | USA | 0 |
NCT03827850 | Phase II | Erdafitinib | FGFR Inhibitor in FGFR Dysregulated Cancer (FIND) | Recruiting | 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 |
NCT04565275 | Phase Ib/II | ICP-192 | A Study of ICP-192 in Patients With Advanced Solid Tumors | Recruiting | USA | 1 |
NCT04463771 | Phase II | Pemigatinib + Retifanlimab Epacadostat + Retifanlimab Retifanlimab | Safety and Efficacy of Retifanlimab (INCMGA00012) Alone or in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-based Chemotherapy. (POD1UM-204) | Recruiting | USA | ITA | FRA | DEU | BEL | 3 |
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 |
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 |
NCT02558348 | Phase Ib/II | Anlotinib | Phase 1/2a Evaluation of AL3818 in Subjects With Recurrent or Metastatic Endometrial, Ovarian or Cervical Cancer (AL3818-US-001) | Terminated | USA | 0 |
NCT02747797 | Phase II | Lucitanib | Lucitanib (E3810) in Patients With Advanced Cancer and FGFR, VEGFR, or PDGFR Pathway Aberrations | Withdrawn | USA | 0 |
NCT03297606 | Phase II | Bosutinib Palbociclib Vismodegib Ipilimumab + Nivolumab Cobimetinib + Vemurafenib Temsirolimus Olaparib Erlotinib Crizotinib Sunitinib Afatinib Dasatinib Pertuzumab + Trastuzumab Axitinib | Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) | Recruiting | CAN | 0 |
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 |
NCT04595747 | Phase II | Rogaratinib | Testing the Anti-cancer Drug, Rogaratinib (BAY 1163877), for Treatment of Advanced Sarcoma With Alteration in Fibroblast Growth Factor Receptor (FGFR 1-4), and in Patients With SDH-deficient Gastrointestinal Stromal Tumor (GIST) | Recruiting | USA | 0 |
NCT03155620 | Phase II | Tazemetostat Larotrectinib LY3023414 Vemurafenib Palbociclib Olaparib Ulixertinib Erdafitinib Selumetinib Ensartinib | Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial) | Recruiting | USA | 1 |
NCT02693535 | Phase II | Cobimetinib + Vemurafenib Atezolizumab + Talazoparib Regorafenib Larotrectinib Trastuzumab + Tucatinib Ipilimumab + Nivolumab Palbociclib Afatinib Entrectinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab Atezolizumab + Pertuzumab/trastuzumab/hyaluronidase-zzxf Crizotinib Abemaciclib Sunitinib Olaparib | TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer (TAPUR) | Recruiting | USA | 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 |
NCT02299141 | Phase I | Nintedanib | Nintedanib in Molecularly Selected Patients With Advanced Non-Small Cell Lung Cancer | Active, not recruiting | USA | 0 |
NCT04526106 | Phase I | RLY-4008 | First-in-human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors | Recruiting | USA | ITA | FRA | ESP | 8 |
NCT02846766 | Phase II | Lenvatinib | Study of Lenvatinib in Patients With Advanced Cancer and Aberrations in FGF/FGFR Signaling | Withdrawn | USA | 0 |
NCT04045613 | Phase Ib/II | Derazantinib Atezolizumab + Derazantinib | Derazantinib and Atezolizumab in Patients With Urothelial Cancer (FIDES-02) | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT | 7 |
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 |
NCT03210714 | Phase II | Erdafitinib | Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial) | Suspended | USA | 1 |
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 |
NCT04504331 | Phase I | Fulvestrant + Infigratinib + Palbociclib Infigratinib + Tamoxifen | Study of Infigratinib in Combination With Tamoxifen or With Fulvestrant and Palbociclib in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer | Recruiting | USA | 0 |
NCT03934372 | Phase Ib/II | Ponatinib | Safety and Efficacy of Ponatinib for Treatment of Pediatric Recurrent or Refractory Leukemias or Solid Tumors | Recruiting | ITA | FRA | ESP | DEU | BEL | 4 |
NCT04604132 | Phase Ib/II | Atezolizumab + Derazantinib Derazantinib + Paclitaxel + Ramucirumab Derazantinib Paclitaxel + Ramucirumab | Derazantinib Alone or in Combination With Paclitaxel, Ramucirumab or Atezolizumab in Gastric Adenocarcinoma (FIDES-03) | Recruiting | USA | ITA | FRA | ESP | DEU | BEL | 9 |
NCT02312804 | Phase I | Paclitaxel Carboplatin Infigratinib | Ph Ib/BGJ398/Cervix and Other Solid Tumors | Withdrawn | 0 | |
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 |
NCT02160041 | Phase II | Infigratinib | BGJ398 for Patients With Tumors With FGFR Genetic Alterations | Terminated | USA | 0 |
NCT01928459 | Phase I | Alpelisib + Infigratinib | Phase 1b Trial of BGJ398/BYL719 in Solid Tumors | Completed | USA | ITA | FRA | ESP | DEU | CAN | BEL | 5 |
NCT03230318 | Phase II | Derazantinib | Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma (FIDES-01) | Active, not recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 4 |
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 |
NCT02265341 | Phase II | Ponatinib | Ponatinib Hydrochloride in Treating Patients With Advanced Biliary Cancer With FGFR2 Fusions | Completed | USA | 0 |
NCT03773302 | Phase III | Cisplatin + Gemcitabine Infigratinib | Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations | Recruiting | USA | ITA | FRA | ESP | DEU | CAN | BEL | 8 |
NCT04972253 | Phase I | Infigratinib | Phase I BLASST-3 Trial ((BLASST)-3) | Recruiting | USA | 0 |
NCT03344536 | Phase Ib/II | Debio 1347 + Fulvestrant | A Study of Debio 1347 Plus Fulvestrant in Patients With Metastatic Breast Cancer | Completed | USA | 0 |
NCT01004224 | Phase I | Infigratinib | A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies | Completed | USA | ITA | FRA | ESP | DEU | AUT | 8 |
NCT04092673 | Phase Ib/II | eFT226 + Fulvestrant eFT226 eFT226 + Sotorasib Abemaciclib + eFT226 + Fulvestrant eFT226 + Trastuzumab | Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies (Zotatifin) | Recruiting | USA | 0 |
NCT04024436 | Phase II | Fulvestrant + Futibatinib Futibatinib | A Study of TAS-120 in Patients With Metastatic Breast Cancer | Recruiting | USA | ITA | FRA | ESP | CAN | 2 |
NCT03238196 | Phase I | Erdafitinib + Fulvestrant + Palbociclib | Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer | Active, not recruiting | USA | 0 |