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Clinical trials for Erdafitinib

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   44336   clinical trials with a EudraCT protocol, of which   7366   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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    8 result(s) found for: Erdafitinib. Displaying page 1 of 1.
    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: 2019-002113-19 Sponsor Protocol Number: 42756493CAN2002 Start Date*: 2019-10-31
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 2 Study of Erdafitinib in Subjects with Advanced Solid Tumors and FGFR Gene Alterations
    Medical condition: Advanced solid tumors (other than Urothelial tumors), and FGFR gene alterations.
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065143 Malignant solid tumour LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) PL (Completed) FR (Completed) DE (Trial now transitioned) ES (Ongoing) BE (Completed) IT (Completed) Outside EU/EEA SE (Prematurely Ended)
    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: 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: 2018-000399-13 Sponsor Protocol Number: Uni-Koeln-3254 Start Date*: 2019-03-08
    Sponsor Name:University of Cologne
    Full Title: A phase II trial to evaluate efficacy and safety of erdafitinib in patients with advanced NSCLC harbouring FGFR genetic alterations after relapse of standard therapy
    Medical condition: •Stage IIIB/IV NSCLC patients with activating FGFR alteration after the failure of ≥ 1st line standard therapy •Activating FGFR alteration as defined by FIND Molecular Board •ECOG performance sta...
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10061873 Non-small cell lung cancer PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2021-005604-35 Sponsor Protocol Number: APEC1621B Start Date*: 2022-01-18
    Sponsor Name:National Cancer Institute (NCI)
    Full Title: NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of JNJ-42756493 (Erdafitinib) in Patients With Tumors Harboring FGFR1/2/3/4 Alterations
    Medical condition: Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations
    Disease: Version SOC Term Classification Code Term Level
    21.1 100000004864 10065143 Malignant solid tumour LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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 (Ongoing) IT (Trial now transitioned)
    Trial results: (No results available)
    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)
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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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