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Clinical trials for Bladder cancer AND FGFR

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
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • 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   44393   clinical trials with a EudraCT protocol, of which   7405   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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    13 result(s) found for: Bladder cancer AND FGFR. Displaying page 1 of 1.
    EudraCT Number: 2016-001321-14 Sponsor Protocol Number: INCB54828-201 Start Date*: 2017-01-12
    Sponsor Name:Incyte Corporation
    Full Title: A Phase 2, Open-Label, Single-Agent, Multicenter Study to Evaluate the Efficacy and Safety of INCB054828 in Subjects With Metastatic or Surgically Unresectable Urothelial Carcinoma Harboring FGF/FG...
    Medical condition: Subjects with metastatic or surgically unresectable urothelial cancer (may include primary site from ureters, upper tract, renal pelvis, and bladder) with an FGF/FGFR alteration, who failed at leas...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005003 Bladder cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Completed) FR (Completed) ES (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2014-002408-26 Sponsor Protocol Number: 42756493BLC2001 Start Date*: 2015-04-16
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2, Two-arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two Different Dose Regimens of a pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects with Metast...
    Medical condition: Urothelial cancer
    Disease: Version SOC Term Classification Code Term Level
    18.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005003 Bladder cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) BE (Completed) IT (Completed) DE (Completed) FR (Trial now transitioned) GB (GB - no longer in EU/EEA) RO (Ongoing) AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-002449-39 Sponsor Protocol Number: 42756493BLC2003 Start Date*: 2020-07-10
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Inva...
    Medical condition: Cohort 1 and 2: High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) with FGFR Mutations or Fusions Cohort 3 Intermediate Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) with FGFR Mutations or Fusi...
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005003 Bladder cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Ongoing) GB (GB - no longer in EU/EEA) ES (Temporarily Halted) PL (Trial now transitioned) BE (Completed) FR (Trial now transitioned) CZ (Prematurely Ended) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2022-002586-15 Sponsor Protocol Number: SOGUG-2020-IEC(VEJ)-11 Start Date*: 2023-03-31
    Sponsor Name:Spanish Oncology Genito Urinary Group (SOGUG)
    Full Title: A Phase 2, open-label, multi-centre, multi-national interventional trial to evaluate the efficacy and safety of erdafitinib (ERDA) monotherapy and erdafitinib (ERDA) and cetrelimab (CET) combinatio...
    Medical condition: Muscle-invasive bladder cancer (MIBC)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) ES (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2016-004340-11 Sponsor Protocol Number: 17403 Start Date*: 2018-06-13
    Sponsor Name:Bayer AG
    Full Title: A randomized, open label, multicenter Phase 2/3 study to evaluate the efficacy and safety of rogaratinib (BAY 1163877) compared to chemotherapy in patients with FGFR-positive locally advanced or me...
    Medical condition: mRNA FGF receptor 1 and 3 positive locally advanced or metastatic urothelial carcinoma progressed after prior platinum-containing chemotherapy
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10064467 Urothelial carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IE (Completed) NL (Prematurely Ended) FR (Completed) AT (Completed) CZ (Completed) ES (Completed) PT (Completed) FI (Completed) SK (Completed) HU (Completed) DK (Completed) BE (Completed) SE (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2017-001980-19 Sponsor Protocol Number: 42756493BLC2002 Start Date*: 2018-04-25
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Erdafitinib plus JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Subjects with Metastatic or Surgically...
    Medical condition: Metastatic or Surgically Unresectable Urothelial Cancer
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10005003 Bladder cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) BE (Completed) GB (GB - no longer in EU/EEA) PL (Completed) IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2019-001833-14 Sponsor Protocol Number: EAURF2018-02 Start Date*: 2020-12-04
    Sponsor Name:EAU Research Foundation
    Full Title: Open-label, single-arm, Phase II study, evaluating safety and efficacy of INCB054828 (Pemigatinib) as adjuvant therapy for molecularly-selected, high-risk patients with urothelial carcinoma who hav...
    Medical condition: pT3-4 and/or pN1-3 urothelial carcinoma (UC) of the urinary bladder or upper urinary tract after radical cystectomy /radical nephroureterectomy previously treated with at least three cycles of ne...
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10046714 Urothelial carcinoma bladder LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-004072-10 Sponsor Protocol Number: MO11/9803 Start Date*: 2012-07-24
    Sponsor Name:University of Leeds
    Full Title: FGFR Inhibition for Epithelial Solid Tumours: a Phase Ib trial of AZD4547 in combination with gemcitabine and cisplatin
    Medical condition: Epithelial Solid Tumours. Locally advanced and/or metastatic transitional cell carcinoma (pure or mixed histology) of (upper or lower) urinary tract, including bladder cancer.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-001483-38 Sponsor Protocol Number: BAY1163877/19131 Start Date*: 2019-09-02
    Sponsor Name:Bayer AG
    Full Title: An international, multicenter, Phase 1b/2 study of rogaratinib (BAY 1163877) in combination with atezolizumab as first-line treatment in cisplatin-ineligible patients with FGFR-positive locally adv...
    Medical condition: FGFR-positive locally advanced or metastatic urothelial carcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10064467 Urothelial carcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) FR (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2017-002932-18 Sponsor Protocol Number: 42756493-BLC3001 Start Date*: 2018-02-08
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 3 Study of Erdafitinib Compared with Vinflunine or Docetaxel or Pembrolizumab in Subjects with Advanced Urothelial Cancer and Selected FGFR Gene Aberrations
    Medical condition: Advanced Urothelial Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10077840 Urothelial cancer of renal pelvis LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Trial now transitioned) HU (Completed) ES (Ongoing) AT (Completed) FR (Trial now transitioned) DE (Ongoing) NL (Ongoing) PT (Completed) GR (Completed) PL (Completed) IT (Completed) DK (Completed) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-002831-14 Sponsor Protocol Number: INCB54828-101 Start Date*: 2017-03-29
    Sponsor Name:Incyte Corporation
    Full Title: A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of INCB054828 in Subjects With Advanced Malignancies (FIGHT-101)
    Medical condition: Advanced Malignancies
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10048683 Advanced cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2015-002228-25 Sponsor Protocol Number: D2615C00001 Start Date*: 2015-11-10
    Sponsor Name:AstraZeneca AB
    Full Title: An Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Multi-Centre, Multi-arm Phase 1b Study in patients with Muscle Invasive Bladder Cancer (MIBC) who have progressed on prior treatment (BISCAY)
    Medical condition: Muscle-invasive bladder cancer
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2020-000945-15 Sponsor Protocol Number: TAS-120-203 Start Date*: 2021-07-28
    Sponsor Name:Taiho Oncology, Inc.
    Full Title: A Phase 2 Study Evaluating Futibatinib (TAS-120) Plus Pembrolizumab in the Treatment of Advanced or Metastatic Urothelial Carcinoma
    Medical condition: Advanced or Metastatic Urothelial Carcinoma
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004864 10064467 Urothelial carcinoma LLT
    20.0 100000004864 10077056 Urothelial carcinoma recurrent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (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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