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Clinical trials for FGFR2

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44338   clinical trials with a EudraCT protocol, of which   7368   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    31 result(s) found for: FGFR2. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2010-023377-19 Sponsor Protocol Number: D2610C00004 Start Date*: 2011-11-03
    Sponsor Name:AstraZeneca
    Full Title: A Randomised Open-Label Phase II Study to Assess the Efficacy & Safety of AZD4547 Monotherapy versus Paclitaxel in Patients with Advanced Gastric Adenocarcinoma (inc. Adenocarcinoma of the Lower Th...
    Medical condition: FGFR, Amplification, polysomy, gastro-oesophageal junction cancer, lower third oesophageal cancer, gastric cancer, randomised, efficacy
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10017758 Gastric cancer PT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10063916 Metastatic gastric cancer PT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10017761 Gastric cancer recurrent PT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061967 Gastric cancer stage IV PT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10030159 Oesophageal carcinoma recurrent PT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10017765 Gastric cancer stage III PT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10026104 Malignant neoplasm of lower third of esophagus LLT
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10030155 Oesophageal carcinoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) CZ (Completed) ES (Completed) BE (Completed) IT (Completed) HU (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2016-004448-12 Sponsor Protocol Number: ARQ087-301 Start Date*: 2017-12-18
    Sponsor Name:ARQULE INC
    Full Title: A Pivotal Trial of ARQ 087 in Subjects with FGFR2 Gene Fusion Positive Inoperable or Advanced Intrahepatic Cholangiocarcinoma
    Medical condition: Inoperable or advanced FGFR2 gene fusion positive intrahepatic cholangiocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10073078 Intrahepatic cholangiocarcinoma recurrent LLT
    20.0 100000004864 10073077 Intrahepatic cholangiocarcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) GB (GB - no longer in EU/EEA) DE (Completed) IE (Completed) ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2011-000266-35 Sponsor Protocol Number: CTKI258A2211 Start Date*: 2012-03-21
    Sponsor Name:NOVARTIS FARMA
    Full Title: A phase II, open-label, single-arm, non-randomized, multi-center study to evaluate the efficacy of oral TKI258 as second-line therapy in patients with either FGFR2 mutated or wild-type advanced and...
    Medical condition: Advanced and/or metastatic endometrial carcinoma
    Disease: Version SOC Term Classification Code Term Level
    14.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10014736 Endometrial cancer recurrent PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) ES (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2018-004004-19 Sponsor Protocol Number: QBGJ398-301 Start Date*: 2020-02-13
    Sponsor Name:QED Therapeutics, Inc.
    Full Title: A Phase 3 Multicenter, Open-Label, Randomized, Controlled Study of Oral Infigratinib versus Gemcitabine with Cisplatin in Subjects with Advanced/Metastatic or Inoperable Cholangiocarcinoma with FGF...
    Medical condition: Cholangiocarcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008593 Cholangiocarcinoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Prematurely Ended) BE (Completed) GB (GB - no longer in EU/EEA) PT (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-004810-16 Sponsor Protocol Number: TPU-TAS-120-101 Start Date*: 2014-04-10
    Sponsor Name:Taiho Oncology Inc
    Full Title: PHASE 1/2 STUDY OF TAS-120 IN PATIENTS WITH ADVANCED SOLID TUMORS HARBORING FGF/FGFR ABERRATIONS
    Medical condition: Advanced solid tumors
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065147 Malignant solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) ES (Completed) DE (Completed) NL (Completed) PT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-002422-36 Sponsor Protocol Number: INCB54828-202 Start Date*: 2017-05-04
    Sponsor Name:Incyte Corporation
    Full Title: A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Advanced/Metastatic or Surgically Unresectable Cholangiocarcinoma Including F...
    Medical condition: Subjects with advanced/metastatic or surgically unresectable cholangiocarcinoma with FGFR2 translocations, with other FGF/FGFR alterations, or who are negative for any FGF/FGFR alterations, who fai...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008593 Cholangiocarcinoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BE (Completed) FR (Completed) GB (GB - no longer in EU/EEA) IT (Completed)
    Trial results: View results
    EudraCT Number: 2018-002894-23 Sponsor Protocol Number: INCB54828-302 Start Date*: 2019-05-30
    Sponsor Name:Incyte Corporation
    Full Title: A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of ...
    Medical condition: Male and female participants at least 18 years of age who have unresectable and/or metastatic cholangiocarcinoma with FGFR2 rearrangement
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008593 Cholangiocarcinoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) SE (Trial now transitioned) DE (Trial now transitioned) AT (Trial now transitioned) FI (Completed) FR (Trial now transitioned) BE (Trial now transitioned) NO (Completed) NL (Trial now transitioned) ES (Ongoing) DK (Completed) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2015-001443-36 Sponsor Protocol Number: ARQ087-101 Start Date*: 2015-08-05
    Sponsor Name:ARQULE INC
    Full Title: A Phase 1/2 Study of ARQ 087 in Adult Subjects with Advanced Solid Tumors with FGFR Genetic Alterations, Including Intrahepatic Cholangiocarcinoma with FGFR2 Gene Fusion
    Medical condition: Advanced Solid Tumors with FGFR Genetic Alterations, Including Intrahepatic Cholangiocarcinoma with FGFR2 Gene Fusion
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004864 10065143 Malignant solid tumour LLT
    20.0 100000004864 10073077 Intrahepatic cholangiocarcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-005085-19 Sponsor Protocol Number: CBGJ398X2204 Start Date*: 2014-06-30
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: A phase II multicenter, single arm study of oral BGJ398 in adult patients with advanced or metastatic cholangiocarcinoma with FGFR2 gene fusions or other FGFR genetic alterations who failed or are ...
    Medical condition: advanced or metastatic cholangiocarcinoma FGFR2 gene fusion, FGFR genetic alteration
    Disease: Version SOC Term Classification Code Term Level
    17.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008593 Cholangiocarcinoma PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) BE (Completed) IT (Completed) DE (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2011-003718-18 Sponsor Protocol Number: CCR3689 Start Date*: 2012-02-09
    Sponsor Name:Royal Marsden Hospital NHS Foundation Trust
    Full Title: Proof-of-concept study of AZD 4547 in patients with FGFR1 or FGFR2 amplified tumours
    Medical condition: Advanced Breast Cancer Advanced Lung Cancer Advanced Upper gastrointestinal cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-004938-38 Sponsor Protocol Number: ADVANCE2020 Start Date*: 2021-12-08
    Sponsor Name:Frankfurter Institut für Klinische Krebsforschung IKF GmbH
    Full Title: ADVANCE: A phase II single-arm, open-label study of Atezolizumab and Derazantinib for patients with advanced intrahepatic cholangiocarcinoma with FGFR2 fusions/rearrangements
    Medical condition: Advanced non-resectable intrahepatic cholangiocarcinoma with positively confirmed FGFR2 fusion/rearrangements via NGS-Analysis
    Disease: Version SOC Term Classification Code Term Level
    27.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008593 Cholangiocarcinoma PT
    27.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008594 Cholangiocarcinoma non-resectable LLT
    27.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073077 Intrahepatic cholangiocarcinoma LLT
    27.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10077846 Cholangiocarcinoma metastatic LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-004630-42 Sponsor Protocol Number: TAS-120-301 Start Date*: 2021-01-25
    Sponsor Name:Taiho Oncology Inc
    Full Title: A Phase 3, Open-Label, Randomized Study of Futibatinib Versus Gemcitabine-Cisplatin Chemotherapy as First-Line Treatment of Patients with Advanced Cholangiocarcinoma Harboring FGFR2 Gene Rearrangem...
    Medical condition: Advanced solid tumors
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065147 Malignant solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) PT (Prematurely Ended) DE (Prematurely Ended) PL (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2019-001164-30 Sponsor Protocol Number: TAS-120-201 Start Date*: 2019-11-22
    Sponsor Name:Taiho Oncology, Inc.
    Full Title: A Phase 2 Study of TAS-120 in Metastatic Breast Cancers Harboring Fibroblast Growth Factor Receptor (FGFR) Amplifications
    Medical condition: Metastatic Breast Cancers Harboring Fibroblast Growth Factor Receptor (FGFR) Amplifications
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10027475 Metastatic breast cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) PT (Completed) ES (Ongoing) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2013-002200-13 Sponsor Protocol Number: CBGJ398X2201 Start Date*: 2014-05-09
    Sponsor Name:NOVARTIS FARMA S.p.A
    Full Title: A Phase 2, multicenter, open-label study of BGJ398 in patients with recurrent resectable or unresectable Glioblastoma
    Medical condition: recurrent resectable or unresectable Glioblastoma
    Disease: Version SOC Term Classification Code Term Level
    16.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10018337 Glioblastoma multiforme PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) NL (Prematurely Ended) ES (Prematurely Ended) BE (Prematurely Ended) DE (Completed)
    Trial results: View results
    EudraCT Number: 2019-004084-49 Sponsor Protocol Number: TAS-120-202 Start Date*: 2020-06-22
    Sponsor Name:Taiho Oncology Inc.
    Full Title: A PHASE 2 STUDY OF FUTIBATINIB IN PATIENTS WITH SPECIFIC FGFR ABERRATIONS
    Medical condition: Fibroblast growth factor receptor (FGFR) aberrations
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10007050 Cancer LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed) GB (GB - no longer in EU/EEA) NL (Completed) FR (Completed) BE (Completed) PT (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2017-003507-22 Sponsor Protocol Number: FPA144-004 Start Date*: 2018-12-19
    Sponsor Name:Five Prime Therapeutics, Inc.
    Full Title: A Phase 3 Randomized, Double-Blind, Controlled Study Evaluating FPA144 and Modified FOLFOX6 in Patients with Previously Untreated Advanced Gastric and Gastroesophageal Cancer: Phase 3 Preceded by ...
    Medical condition: Advanced Gastric and Gastroesophageal Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10017758 Gastric cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) GB (GB - no longer in EU/EEA) DE (Completed) PT (Completed) FR (Completed) BE (Completed) ES (Ongoing) RO (Completed) PL (Prematurely Ended) IT (Completed)
    Trial results: View results
    EudraCT Number: 2011-002445-36 Sponsor Protocol Number: 0001 Start Date*: 2011-10-31
    Sponsor Name:Department of Clinical Oncology, Leiden University Medical Center
    Full Title: Neo-adjuvant dovitinib in patients with hepatocellular carcinoma prior to local treatment: a phase II study
    Medical condition: Hepatocellular carcinoma, not metastatic
    Disease: Version SOC Term Classification Code Term Level
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10019830 Hepatocellular carcinoma resectable LLT
    14.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10019828 Hepatocellular carcinoma non-resectable LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-004740-24 Sponsor Protocol Number: INCB54828-209 Start Date*: 2022-06-29
    Sponsor Name:Incyte Corporation
    Full Title: A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Glioblastoma or Other Primary Central Nervous System ...
    Medical condition: Participants at least 18 years of age who have recurrent GBM or other recurrent gliomas, circumscribed astrocytic gliomas, and glioneuronal and neuronal tumors, harboring an FGFR1-3 mutation or fus...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065147 Malignant solid tumor LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Ongoing) DK (Completed) FR (Completed) IT (Completed) NL (Completed)
    Trial results: (No results available)
    EudraCT Number: 2018-003584-53 Sponsor Protocol Number: Debio1347-201 Start Date*: 2019-02-05
    Sponsor Name:Debiopharm International SA
    Full Title: A Phase II basket study of the oral selective pan-FGFR inhibitor Debio 1347 in subjects with solid tumors harboring a fusion of FGFR1, FGFR2 or FGFR3
    Medical condition: Three cohorts will be included consisting of subjects with biliary tract cancer (Cohort 1), urothelial cancer (Cohort 2) and all other solid tumor histologies not included in Cohorts 1-2 such as NS...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GR (Completed) AT (Completed) NL (Ongoing) GB (GB - no longer in EU/EEA) CZ (Prematurely Ended) DK (Completed) NO (Completed) BG (Completed) FI (Completed) ES (Temporarily Halted) HR (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2020-004535-24 Sponsor Protocol Number: RLY-4008-101 Start Date*: 2021-07-07
    Sponsor Name:Relay Therapeutics, Inc.
    Full Title: A First-in-Human Study of Highly Selective FGFR2 inhibitor, RLY-4008, in Patients with Intrahepatic Cholangiocarcinoma (ICC) and other Advanced Solid Tumors
    Medical condition: Unresectable or metastatic cholangiocarcinoma (CCA), other advanced solid tumors with an FGFR2-alteration or other potential FGFR2-dependent tumors
    Disease: Version SOC Term Classification Code Term Level
    27.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10073077 Intrahepatic cholangiocarcinoma LLT
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10065252 Solid tumor LLT
    27.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10008595 Cholangiocarcinoma NOS LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10014735 Endometrial cancer NOS LLT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10017760 Gastric cancer NOS LLT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006192 Breast cancer NOS LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Trial now transitioned) NL (Trial now transitioned) DE (Trial now transitioned)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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