Clinical trials: FGFR2 Gene Mutation
Cancer, Cancer Metastatic
Real Word European Registry of NTRK Fusions and Other Rare Actionable Fusions (TRacKING)
This registry will make it possible to describe real life management of patients with rare actionable fusions and to better understand these cancers.
- Conditions
- Cancer, Cancer Metastatic, NTRK Gene Fusion Overexpression, NTRK Family Gene Mutation
- Trial name
- TRacKING (NCT04921553)
- Testing
- Data collection and quality of life questionnaire
- Where
- 41 sites in Austria, Czechia and 9 more
- Volunteers
- 500 people
- Sponsor
- Centre Leon Berard
Advanced Cholangiocarcinoma, FGFR2 Gene Mutation
A Phase II, Single Arm Study of BGJ398 in Patients With Advanced Cholangiocarcinoma
This is a multi-center, open label, single arm phase II study evaluating BGJ398 (infigratinib) anti-tumor activity in advanced or metastatic cholangiocarcinoma patients with fibroblast growth factor receptor (FGFR) genetic…
- Trial name
- NCT02150967
- Testing
- BGJ398 (infigratinib)
- Where
- 37 sites in United States, Belgium and 9 more
- Volunteers
- 143 people
- Sponsor
- QED Therapeutics, a BridgeBio company
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
Advanced Cholangiocarcinoma, FGFR2 Gene Mutation
Phase 3 Study of BGJ398 (Oral Infigratinib) in First Line Cholangiocarcinoma With FGFR2 Gene Fusions/Translocations
Infigratinib is an oral drug which selectively binds to fibroblast growth factor receptor (FGFR) 2 and is being developed to treat participants with FGFR2 mutated cholangiocarcinoma.
- Trial name
- NCT03773302
- Testing
- BGJ398, Gemcitabine, Cisplatin
- Where
- 116 sites in United States, Australia and 13 more
- Volunteers
- 48 people
- Sponsor
- QED Therapeutics, a BridgeBio company
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
Solid Tumor
Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations
This was an open-label, Phase 1/2, dose escalation and signal finding study of derazantinib administered to patients with advanced solid tumors (Part 1; Dose Escalation/Food-effect Cohorts) or with advanced solid tumors with FGFR…
- Trial name
- NCT01752920
- Testing
- Derazantinib low dose range, Derazantinib middle dose range, Derazantinib high dose range
- Where
- 12 sites in United States, Italy
- Volunteers
- 119 people
- Sponsor
- Basilea Pharmaceutica
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
Intrahepatic Cholangiocarcinoma, FGFR2 Gene Rearrangement
A Phase II Study of Pemigatinib Plus Durvalumab in Previously Treated Advanced Intrahepatic Cholangiocarcinoma Patients With FGFR-2 Fusion or Rearrangement
This is a single arm phase II study of pemigatinib and durvalumab combination in patients with FGFR-2 fusion or rearrangement positive intrahepatic cholangiocarcinoma. Each cycle will be 3 weeks.
- Conditions
- Intrahepatic Cholangiocarcinoma, FGFR2 Gene Rearrangement, FGFR2 Gene Mutation
- Trial name
- NCT06728410
- Testing
- Pemigatinib, Durvalumab
- Where
- 3 sites in United States
- Volunteers
- 38 people
- Sponsor
- Mehmet Akce
Intrahepatic Cholangiocarcinoma, FGFR2 Gene Mutation
Pemigatinib After Curative Local Therapy in Advanced iCCA With FGFR2 Fusion/Rearrangements
The aim of this phase II study is to determine whether pemigatinib is clinically efficious after curative local therapy such as surgery/ SBRT or ablation in iCCA patients harboring FGFR2 fusion/rearrangement and to assess the…
- Conditions
- Intrahepatic Cholangiocarcinoma, FGFR2 Gene Mutation, FGFR2 Gene Rearrangement, FGFR2 Gene Translocation
- Trial name
- NCT05565794
- Testing
- Pemigatinib
- Where
- 10 sites in Germany
- Volunteers
- 2 people
- Sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Cholangiocarcinoma, FGFR2 Fusion
Study to Evaluate the Efficacy and Safety of TT-00420 (Tinengotinib) in Cholangiocarcinoma
This study is an open-label, multicenter study to evaluate the efficacy and safety of TT-00420 tablet in adult patients with advanced cholangiocarcinoma.
- Conditions
- Cholangiocarcinoma, FGFR2 Fusion, FGFR2 Gene Mutation, FGFR1 Alteration
- Trial name
- NCT04919642
- Testing
- TT-00420
- Where
- 32 sites in United States
- Volunteers
- 55 people
- Sponsor
- TransThera Sciences (Nanjing), Inc.
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
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
Biliary Tract Cancer
ctDNA in Genetic Profiling and Clinical Outcomes of Advanced Biliary Tract Cancer
This prospective, multicenter, observational study aims to evaluate the role of circulating tumor DNA (ctDNA) in advanced or metastatic biliary tract cancer (BTC) patients in Korea.
- Trial name
- NCT07151118
- Testing
- Blood Sampling for ctDNA Analysis
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- CHA University
Advanced Solid Tumor, CNS Tumor
Study With Infigratinib in Subjects With Advanced Solid and CNS Tumors or Recurrent or Progressive Low-Grade Glioma With Selected FGFR1-3 Alterations
The phase 1b study is aimed at determining the pediatric recommended phase 2 dose (RP2D) of Infigratinib. The phase 2 study will evaluate efficacy and safety of infigratinib.
- Conditions
- Advanced Solid Tumor, CNS Tumor, Recurrent WHO Grade II Glioma
- Trial name
- NEWEL (NCT05222165)
- Testing
- Infigratinib
- Where
- 10 sites in United States, Canada and 1 more
- Sponsor
- Helsinn Healthcare SA
Malignant Neoplasm
Ponatinib for Patients Whose Advanced Solid Tumor Cancer Has Activating Mutations Involving the Following Genes: FGFR1, FGFR2, FGFR3, FGFR4, RET, KIT.
This phase II trial studies how well ponatinib hydrochloride works in treating patients with cancer that has spread to other parts of the body (metastatic), has failed previous treatment (refractory), and has one of several…
- Trial name
- NCT02272998
- Testing
- ponatinib hydrochloride, laboratory biomarker analysis
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Sameek Roychowdhury
Biliary Tract Cancer
Role of ctDNA in Genetic Profiling & Outcomes for Advanced BTC
Biliary tract cancer (BTC) is a rare and heterogeneous disease with high incidence and mortality in Korea. Molecular profiling has enabled the identification of actionable alterations such as Isocitrate Dehydrogenase 1 (IDH1)…
- Trial name
- NCT07142226
- Testing
- Circulating Tumor DNA (ctDNA) Testing (ctDNA-based Next-Generation Sequencing (NGS))
- Where
- South Korea
- Volunteers
- 200 people
- Sponsor
- CHA University