Clinical trials: FGFR2 Gene Amplification
Intrahepatic Cholangiocarcinoma, Combined Hepatocellular and Cholangiocarcinoma
Derazantinib in Subjects With FGFR2 Gene Fusion-, Mutation- or Amplification- Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma
This Phase II, open-label, single-arm study evaluated the anti-cancer activity of derazantinib in subjects with inoperable or advanced intrahepatic cholangiocarcinoma (iCCA) who received at least one prior regimen of systemic…
- Trial name
- FIDES-01 (NCT03230318)
- Testing
- derazantinib
- Where
- 41 sites in United States, Belgium and 9 more
- Volunteers
- 148 people
- Sponsor
- Basilea Pharmaceutica
Intrahepatic Cholangiocarcinoma (Icc), Cholangiocarcinoma
A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors
This is an open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4859 in adult…
- Conditions
- Intrahepatic Cholangiocarcinoma (Icc), Cholangiocarcinoma, Other Solid Tumors, Adult, FGFR2 Gene Fusion/Rearrangement
- Trial name
- NCT06777316
- Testing
- CGT4859
- Where
- 13 sites in United States, Canada
- Volunteers
- 110 people
- Sponsor
- Cogent Biosciences, Inc.
Cholangiocarcinoma, Liver Cancer
Phase Ib Trial of Infigratinib In Combination With Atezolizumab And Bevacizumab for The Second-Line Treatment of Advanced Cholangiocarcinoma With FGFR2 Fusion/Amplification
To find the highest tolerable dose of infigratinib that can be given in combination with bevacizumab and atezolizumab to patients with advanced/metastatic CCA with a FGFR2 mutation.
- Trial name
- NCT05510427
- Testing
- Infigratinib, Atezolizumab, Bevacizumab
- Sponsor
- M.D. Anderson Cancer Center
FGFR1 Gene Amplification, FGFR1 Gene Mutation
Lung-MAP: AZD4547 as Second-Line Therapy in Treating FGFR Positive Patients With Recurrent Stage IV Squamous Cell Lung Cancer
This phase II/III trial studies how well FGFR inhibitor AZD4547 (AZD4547) works in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment.
- Conditions
- FGFR1 Gene Amplification, FGFR1 Gene Mutation, FGFR2 Gene Amplification, FGFR2 Gene Mutation
- Trial name
- NCT02965378
- Testing
- Docetaxel, FGFR Inhibitor AZD4547, Laboratory Biomarker Analysis
- Where
- 1,084 sites in United States, Canada
- Volunteers
- 43 people
- Sponsor
- SWOG Cancer Research Network
Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3, Squamous Lung Cancer With FGFR1 Amplification
A Dose Escalation Study in Adult Patients With Advanced Solid Malignancies
The study will determine the maximum tolerated dose and thus the recommended phase II dose and schedule of the compound and characterize the safety.
- Conditions
- Advanced Solid Tumors With Alterations of FGFR1, 2 and or 3, Squamous Lung Cancer With FGFR1 Amplification, Bladder Cancer With FGFR3 Mutation or Fusion, Advanced Solid Tumors With FGFR1 Amplication
- Trial name
- NCT01004224
- Testing
- BGJ398
- Where
- 50 sites in United States, Australia and 12 more
- Volunteers
- 208 people
- Sponsor
- Novartis Pharmaceuticals
FGFR Gene Amplification, FGFR1 Gene Amplification
BGJ398 in Treating Patients With FGFR Positive Recurrent Head and Neck Cancer
This phase IIa trial studies how well the experimental drug, BGJ398 (infigratinib), works in treating patients with fibroblast growth factor receptor (FGFR) 1-3 translocated, mutated, or amplified head and neck cancer that has…
- Conditions
- FGFR Gene Amplification, FGFR1 Gene Amplification, FGFR2 Gene Amplification, FGFR2 Gene Mutation
- Trial name
- NCT02706691
- Testing
- BGJ398
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- University of Chicago
FGFR1 Gene Amplification, FGFR1 Gene Mutation
Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations
This phase II trial studies how well pemigatinib works in treating patients with colorectal cancer with mutations (alterations) in a FGFR gene and that has spread to other places in the body (metastatic) or cannot be removed by…
- Conditions
- FGFR1 Gene Amplification, FGFR1 Gene Mutation, FGFR1 Gene Translocation, FGFR2 Gene Amplification
- Trial name
- NCT04096417
- Testing
- Pemigatinib, Quality-of-Life Assessment
- Where
- 6 sites in United States
- Volunteers
- 14 people
- Sponsor
- Academic and Community Cancer Research United
Bladder Cancer, Urothelial Carcinoma
Biomarker Research Study for Patients With FGFR-Mutant Bladder Cancer Receiving Erdafitinib
Bladder cancers are associated with genetic mutations that are present in the patient's bladder or urothelium, the lining of the lower urinary tract.
- Conditions
- Bladder Cancer, Urothelial Carcinoma, Transitional Cell Carcinoma, Platinum-Resistant Urothelial Carcinoma
- Trial name
- NCT05052372
- Testing
- Balversa
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- xCures
Solid Tumor, FGF Receptor Gene Mutation
Pemigatinib for FGF/FGFR Alterations Advanced Pan Solid Tumors
The purpose of this clinical trial is to demonstrate safety and efficacy of Pemigatinib in the treatment of advanced pan solid tumor patients with FGF/FGFR alterations.
- Conditions
- Solid Tumor, FGF Receptor Gene Mutation, FGF Amplification, FGF Receptor Gene Family Rearrangement
- Trial name
- NCT06022289
- Testing
- Pemigatinib
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Tianjin Medical University Second Hospital
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Infigratinib in Subjects With GC or GEJ With FGFR2 Amplification or Other Solid Tumors With Other FGFR Alterations
Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 1-3. This is a multicenter, open-label, single arm phase IIa study to evaluate the efficacy and safety of Infigratinib in subjects…
- Conditions
- Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, Solid Tumor
- Trial name
- FGFR (NCT05019794)
- Testing
- Infigratinib
- Where
- 17 sites in China
- Volunteers
- 80 people
- Sponsor
- LianBio LLC
Locally Advanced Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma
Safety and Anti-Tumor Activity of TYRA-200 in Advanced Cholangiocarcinoma With Activating FGFR2 Gene Alterations
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of TYRA-200 in cancers with FGFR2 activating gene alterations, including unresectable locally…
- Conditions
- Locally Advanced Cholangiocarcinoma, Intrahepatic Cholangiocarcinoma, Solid Tumor, Metastatic Cholangiocarcinoma
- Trial name
- SURF201 (NCT06160752)
- Testing
- Phase 1 Part A - dose escalation TYRA-200 taken once daily by mouth in 28-day cycles, Phase 1 Part B - dose expansion TYRA-200 taken once daily by mouth in 28-day cycles
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- Tyra Biosciences, Inc
Gastro-oesophageal Junction Cancer, Gastric Cancer
Efficacy and Safety of AZD4547 Versus Paclitaxel in Patients With Advanced Gastric or Gastro-oesophageal Cancer
The purpose of this study is to assess the efficacy, safety and tolerability of AZD4547 compared with paclitaxel in patients with advanced gastric or lower-oesophageal cancer whose tumours are found to have FGFR2 polysomy or gene…
- Trial name
- SHINE (NCT01457846)
- Testing
- AZD4547, paclitaxel
- Where
- 61 sites in Belgium, Bulgaria and 14 more
- Volunteers
- 960 people
- Sponsor
- AstraZeneca
Metastatic Gastric Cancer, PD-L1 Gene Amplification
Nivolumab in Combination With Chemotherapy for FGFR2-positive Metastatic Gastric Cancer
The goal of this phase 2 clinical trial is to evaluate the efficacy of nivolumab in combination with CAPOX in patients with FGFR2-positive/PD-L1-positive/HER2-negative metastatic gastric cancer.
- Conditions
- Metastatic Gastric Cancer, PD-L1 Gene Amplification, FGFR2 Amplification
- Trial name
- NIVOFGFR2 (NCT05859477)
- Testing
- Nivolumab, Capecitabine, Oxaliplatin
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Kidney Cancer Research Bureau
Gastric Cancer
Dovitinib for Gastric Cancer With FGFR2 Amplification: GASDOVI-1
This is a single-center, prospective, single-arm, open-label phase II study
- Trial name
- NCT01719549
- Testing
- Dovitinib
- Where
- South Korea
- Volunteers
- 19 people
- Sponsor
- Asan Medical Center
Refractory Solid Tumors
Single-arm Study to Evaluate the Safety and Efficacy of Sunitinib, in Subjects With RET Fusion Positive or FGFR2 Amplification, Refractory Solid Tumors
This is a pilot study of sunitinib in patients with RET fusion positive or FGFR2 Amplification Refractory solid tumors. This study is a single-arm, pilot study of sunitinib in subjects with Refractory solid tumors harboring RET…
- Trial name
- NCT02450123
- Testing
- sunitinib
- Where
- South Korea
- Volunteers
- 1 people
- Sponsor
- Samsung Medical Center
Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Evaluation of Infigratinib in Patients With Locally Advanced or Metastatic Gastric Cancer or GEJ Adenocarcinoma
This is a multicenter, open-label, single arm phase II study to evaluate the efficacy and safety of Infigratinib in patients with locally advanced or metastatic GC or GEJ patient with FGFR2 gene amplification, who have failed at…
- Trial name
- NCT06206278
- Testing
- Infigratinib
- Where
- 30 sites in China
- Volunteers
- 6 people
- Sponsor
- LianBio LLC
Refractory Solid Tumors
Single-arm Study to Evaluate the Safety and Efficacy of Pazopanib, in Subjects With FGFR2 Amplification, FGFR2 Mutation Refractory Solid Tumors
This is a pilot study of Pazopanib in patients with FGFR2 Amplification or FGFR2 mutation Refractory solid tumors. This study is a single-arm, pilot study of Pazopanib in subjects with Refractory solid tumors harboring FGFR2…
- Trial name
- NCT02450136
- Testing
- pazopanib
- Where
- South Korea
- Volunteers
- 2 people
- Sponsor
- Samsung Medical Center
Metastatic Breast Cancer, FGFR 1 High Amplification
A Study of TAS-120 in Patients With Metastatic Breast Cancer
The purpose of the trial is to evaluate a patient's response to a Fibroblast Growth Factor Receptor (FGFR) inhibitor, futibatinib (TAS-120), used either alone or in combination with the hormonal therapy, fulvestrant.
- Conditions
- Metastatic Breast Cancer, FGFR 1 High Amplification, FGFR2 Amplification
- Trial name
- NCT04024436
- Testing
- Futibatinib, Futibatinib plus Fulvestrant
- Where
- 37 sites in United States, Canada and 5 more
- Volunteers
- 64 people
- Sponsor
- Taiho Oncology, Inc.
FGFR2 Amplification, FGFR2 Gene Mutation
REFOCUS: A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors
This is a Phase 1/2, open-label, FIH study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDy), and antineoplastic activity of RLY-4008, a potent and highly selective FGFR2 inhibitor, in…
- Conditions
- FGFR2 Amplification, FGFR2 Gene Mutation, FGFR2 Gene Fusion/Rearrangement, FGFR2 Gene Translocation
- Trial name
- NCT04526106
- Testing
- RLY-4008
- Where
- 48 sites in United States, Australia and 11 more
- Volunteers
- 490 people
- Sponsor
- Elevar Therapeutics