5 terminated, 3 completed, 1 recruiting, 1 unknown. 8 Phase 2, 2 Phase 3, 1 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 8 | Completed 3, Terminated 3, Recruiting 1, Unknown 1 |
| Phase 3 | 2 | Completed 1, Terminated 1 |
| Phase 1 | 1 | Completed 1 |
Follow FGFR2 Gene Mutation: new trials by email Literature Review of FGFR2 Gene Mutation trials Research Report on FGFR2 Gene Mutation
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement Pemigatinib, Durvalumab - Intrahepatic Cholangiocarcinoma, FGFR2 Gene Rearrangement | Phase 2 | Recruiting | Mehmet Akce | 38 | 2026-01-27 | 2026-10-05 |
| Pemigatinib After Curative Local Therapy in Advanced iCCA With FGFR2 Fusion/Rearrangements Pemigatinib - Intrahepatic Cholangiocarcinoma, FGFR2 Gene Mutation | Phase 2 | Terminated | Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest | 2 | 2022-11-11 | 2025-04-13 |
| Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) in Cholangiocarcinoma TT-00420 - Cholangiocarcinoma, FGFR2 Fusion | Phase 2 | Completed | TransThera Sciences (Nanjing), Inc. | 55 | 2021-12-07 | 2024-06-25 |
| Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib Balversa - Bladder Cancer, Urothelial Carcinoma | Terminated | xCures | 2 | 2021-11-21 | 2022-12-22 | |
| REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors RLY-4008 - FGFR2 Amplification, FGFR2 Gene Mutation | Phase 1 / Phase 2 | Completed | Elevar Therapeutics | 490 | 2020-09-02 | 2026-02-27 |
| Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations Pemigatinib, Quality-of-Life Assessment - FGFR1 Gene Amplification, FGFR1 Gene Mutation | Phase 2 | Unknown | Academic and Community Cancer Research United | 14 | 2020-08-31 | 2024-02-21 |
| Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations BGJ398, Gemcitabine, Cisplatin - Advanced Cholangiocarcinoma, FGFR2 Gene Mutation | Phase 3 | Terminated | QED Therapeutics, a BridgeBio company | 48 | 2019-12-27 | 2024-05-08 |
| BGJ398 in Treating Patients With FGFR Positive Recurrent Head and Neck Cancer BGJ398 - FGFR Gene Amplification, FGFR1 Gene Amplification | Phase 2 | Terminated | University of Chicago | 1 | 2018-06-01 | 2019-04-16 |
| Lung-MAP: AZD4547 as Second-Line Therapy in Treating FGFR Positive Patients With Recurrent Stage IV Squamous Cell Lung Cancer Docetaxel, FGFR Inhibitor AZD4547, Laboratory Biomarker Analysis - FGFR1 Gene Amplification, FGFR1 Gene Mutation | Phase 2 / Phase 3 | Completed | SWOG Cancer Research Network | 43 | 2014-10-01 | 2021-05-27 |
| A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma BGJ398 (infigratinib) - Advanced Cholangiocarcinoma, FGFR2 Gene Mutation | Phase 2 | Terminated | QED Therapeutics, a BridgeBio company | 143 | 2014-07-23 | 2023-07-03 |
Cholangiocarcinoma (6) · Carcinoma, Transitional Cell (1) · Colorectal Neoplasms (1) · Nasopharyngeal Neoplasms (1) · Papillomavirus Infections (1) · Squamous Cell Carcinoma of Head and Neck (1) · Urinary Bladder Neoplasms (1)
Neoplasms (9) · Carcinoma (8) · Neoplasms by Histologic Type (8) · Neoplasms, Glandular and Epithelial (8) · Adenocarcinoma (6) · Neoplasms by Site (3) · Urogenital Diseases (2) · Carcinoma, Squamous Cell (1) · Colonic Diseases (1) · Communicable Diseases (1) · DNA Virus Infections (1) · Digestive System Diseases (1) · Digestive System Neoplasms (1) · Disease Attributes (1) · Female Urogenital Diseases (1)
infigratinib (3) · pemigatinib (3) · AZD4547 (1) · Cisplatin (1) · Docetaxel (1) · Gemcitabine (1) · durvalumab (1) · erdafitinib (1)
QED Therapeutics, a BridgeBio company (2) · Academic and Community Cancer Research United (1) · Elevar Therapeutics (1) · Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest (1) · Mehmet Akce (1) · SWOG Cancer Research Network (1) · TransThera Sciences (Nanjing), Inc. (1) · University of Chicago (1) · xCures (1)
United States (9) · Germany (4) · Italy (3) · South Korea (3) · Spain (3) · Taiwan (3) · United Kingdom (3) · Australia (2) · Belgium (2) · Canada (2) · France (2) · Singapore (2) · Thailand (2) · China (1) · Hong Kong (1)
Daniel J. George, MD (1) · Kristen K Ciombor (1) · Mehmet Akce, MD (1) · Milind Javle, MD (1) · Salah-Eddin Al-Batran, Prof. Dr. (1) · Tanguy Seiwert (1) · Thorsten Goetze, Prof. Dr. (1) · Vassiliki Papadimitrakopoulou (1)
PMID 25763789, PMID 29182496, PMID 32580579, PMID 34358484, PMID 40515475, PMID 41349554, PMID 41571046
2018 (1), P30CA015083 (1), U10CA180888 (1)