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    Summary
    EudraCT Number:2018-000399-13
    Sponsor's Protocol Code Number:Uni-Koeln-3254
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-10-18
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2018-000399-13
    A.3Full title of the trial
    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
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of advanced lung cancer
    A.3.2Name or abbreviated title of the trial where available
    FIND
    A.4.1Sponsor's protocol code numberUni-Koeln-3254
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity of Cologne
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Pharmaceutica N.V.
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hopital of Cologne
    B.5.2Functional name of contact pointLung Cancer Group Cologne
    B.5.3 Address:
    B.5.3.1Street AddressKerpener Str. 62
    B.5.3.2Town/ cityCologne
    B.5.3.3Post code50937
    B.5.3.4CountryGermany
    B.5.4Telephone number+4922147887008
    B.5.5Fax number+492214783978
    B.5.6E-maillucia.nogova@uk-koeln.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameErdafitinib 3mg Tablets
    D.3.2Product code JNJ-42756493
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNErdafitinib
    D.3.9.1CAS number 1346242-81-6
    D.3.9.2Current sponsor codeJNJ-427556493
    D.3.9.3Other descriptive nameERDAFITINIB
    D.3.9.4EV Substance CodeSUB167731
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameErdafitinib 4mg Tablets
    D.3.2Product code JNJ-42756493
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNErdafitinib
    D.3.9.1CAS number 1346242-81-6
    D.3.9.2Current sponsor codeJNJ-427556493
    D.3.9.3Other descriptive nameERDAFITINIB
    D.3.9.4EV Substance CodeSUB167731
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameErdafitinib 5mg Tablets
    D.3.2Product code JNJ-42756493
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNErdafitinib
    D.3.9.1CAS number 1346242-81-6
    D.3.9.2Current sponsor codeJNJ-427556493
    D.3.9.3Other descriptive nameERDAFITINIB
    D.3.9.4EV Substance CodeSUB167731
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    •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 status score 0, 1, or 2.
    E.1.1.1Medical condition in easily understood language
    Pat.with advanced NSCLC and FGFR alterations,in good clinical condition(ECOG 0-2),with acc. lab. results,after standard treatment and consenting for a fresh frozen biopsy will be considered eligible
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of erdafitinib in NSCLC with FGFR genetic alteration
    E.2.2Secondary objectives of the trial
    •To evaluate the tolerability of erdafitinib (endpoints: assessment of adverse events (AEs) according to CTC-AE V5.0)
    •To evaluate the clinical efficacy of erdafitinib descriptively (endpoints: progression-free survival (PFS), overall survival (OS))
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Age > 18 years
    •Stage IIIB/IV NSCLC patients with activating FGFR alteration after failure on standard treatment, or in the opinion of the investigator no effective standard therapy exists, is appropriate, tolerated, or is considered equivalent to study treatment
    •Activating FGFR alteration as approved by FIND Molecular Board
    •ECOG performance status score 0, 1, or 2.
    •Must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
    •Clinical laboratory values and cardiovascular measurements at screening:
    Hematology
    Hemoglobin 8 g/dL (5 mmol/L) (must be without red blood cell [RBC] transfusion within 7 days prior to the laboratory test; recombinant human erythropoietin use is permitted)
    Platelets 75×109/L
    Absolute Neutrophil Count (ANC) 1.5×109/L (prior growth factor support is permitted more than 7 days prior to the laboratory test)
    Chemistry
    AST and ALT ≤2.5 × upper limit of normal (ULN) or
    ≤5 × ULN for patients with liver metastases
    Creatinine clearance 40 mL/min based upon CKD-EPI formula
    Total bilirubin ≤1.5 × ULN; except in patients with congenital bilirubinemia, such as Gilbert syndrome (in which case direct bilirubin ≤1.5 × ULN is required)
    Cardiovascular
    Corrected QT interval according to Fridericia (QTcF) ≤480 msec based on the average of triplicate assessments performed approximately 5 minutes apart
    ALT=alanine aminotransferase; ANC=absolute neutrophil count; AST=aspartate aminotransferase; GFR=glomerular filtration rate; QTcF=QT corrected interval by the Fridericia’s formula; ULN=upper limit of normal

    •Disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for cohort 1 and 2.
    •A woman of childbearing potential (WOCBP) who is sexually active must have a negative pregnancy test (beta- human chorionic gonadotropin [beta-hCG]) at Screening (urine or serum, minimum sensitivity 25 IU/L or equivalent units of beta-HCG) within 24 hours prior to the start of erdafitinib.
    •WOCBP and men who are sexually active with WOCBP must use appropriate method(s) of contraception with a failure rate of less than 1% per year before study entry, during the study and until 5 months after taking the last dose of study drug.
    Note: Appropriate methods of contraception are:
    Total abstinence, if it is the appropriate lifestyle, female sterilization or tubal ligation (at least 6 weeks prior to the start of the study treatment), male sterilization (at least 6 months prior to the start of the study treatment) and/or a combination of a hormonal method of contraception with a barrier method or/and an intrauterine device or system are considered as highly effective methods of contraception.
    •Sexually active men must use a condom to prevent delivery of the drug via seminal fluid
    •Women must not be breastfeeding.
    •Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) as well as azoospermic men do not require contraception.
    •Women and men must agree not to donate eggs (ova, oocytes) or sperm, respectively, during the study and for 5 months after the last dose of study drug
    E.4Principal exclusion criteria
    •Pathogenic somatic alterations in the following genes: EGFR, BRAF, ALK ROS1 and NTRK (Please note that molecular testing might be reduced in heavy smokers with NSCLC. If discrepancies occur, please contact the sponsor). •Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 30 days or 5 half-life times (whichever is longer) prior to recruitment.
    •Treatment with small molecules or chemotherapy within 7 days prior to C1D1
    •Treatment with monoclonal antibodies within 28 days prior to C1D1.
    •Any other ongoing malignancy that would potentially interfere with the interpretation of erdafitinib efficacy.
    •Symptomatic central nervous system metastases.
    •Received prior FGFR inhibitor treatment or if the patient has known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients
    •Any corneal or retinal abnormality likely to increase the risk of eye toxicity, i.e.:
    a.History of or current evidence of central serous retinopathy (CeSR) or retinal vascular occlusion (RVO)
    b.Active wet, age-related macular degeneration (AMD)
    c.Diabetic retinopathy with macular edema (non-proliferative)
    d.Uncontrolled glaucoma (per local standard of care)
    e.Corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration.
    •Has persistent phosphate level >ULN during screening (on 2 consecutive assessments at least 1 week apart, within 14 days prior to Cycle 1 Day 1) and despite medical management
    •Has a history of current uncontrolled cardiovascular disease including:
    a.unstable angina, myocardial infarction, ventricular fibrillation, Torsades de Pointes tachycardia, cardiac arrest, or known congestive heart failure NYHA Class III-V within the preceding 3 months (Appendix 3); cerebrovascular accident or transient ischemic attack within the preceding 3 months.
    b.QTcF prolongation as confirmed by triplicate assessment at screening (QTcF >480 milliseconds).
    •Pulmonary embolism or other VTE (venous thromboembolism) within the preceding 2 months
    •Known human immunodeficiency virus (HIV) infection, testing is mandatory (a-HIV 1/2)
    •Patients with acute or chronic Hepatitis B infection (tests should include assessment of HBsAg and HBc IgG antibody. If one parameter is positive, determine HBV-DNA to confirm acute infection. Patients with positive results for HBsAg and/or HBV-DNA are considered positive for acute or chronic infection)
    •Patients with acute or chronic Hepatitis C infection (determine HCV-RNA. Patients with positive result for HCV-RNA are considered positive for acute or chronic infection)
    •Has not recovered from reversible toxicity of prior anticancer therapy (except toxicities which are not clinically significant such as alopecia, skin discoloration, Grade 1 neuropathy, Grade 1-2 hearing loss)
    •Has impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions
    •Major surgery within 2 weeks of the first dose, or will not have fully recovered from surgery, or has surgery planned during the time the patient is expected to participate in the study or within 2 weeks after the last dose of study drug administration. (Note: patients with planned surgical procedures to be conducted under local anesthesia may participate).
    •Any serious underlying medical condition, such as:
    a. Evidence of serious active viral, bacterial, or uncontrolled systemic fungal infection requiring current systemic treatment
    b. Psychiatric conditions (eg, alcohol or drug abuse), dementia, or altered mental status
    •Any other issue that would impair the ability of the patient to receive or tolerate the planned treatment at the investigational site, to understand informed consent or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (i.e., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.

    E.5 End points
    E.5.1Primary end point(s)
    Overall response rate (ORR) per RECIST 1.1 under erdafitinib treatment in NSCLC with genetic alteration in FGFR
    E.5.1.1Timepoint(s) of evaluation of this end point
    See protocol
    E.5.2Secondary end point(s)
    •Assessment of adverse events (AEs) according to CTC-AE V5.0)
    •Progression-free survival (PFS), overall survival (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    See protocol
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker by drug resistance
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned11
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Pat with a leg.rep.are also allowed to sign ICF.This was impl. since oncologic pat may be altered by prev.therapy eg,whole brain radia. ect.and thus,might have a legal rep.in order to not discriminate pat it was decided to allow ICFsig. by legal rep.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will be instructed that erdafitinib will not be made available to them after they have completed/discontinued study agent and that they should return to their primary physician to determine standard of care.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-02-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-08
    P. End of Trial
    P.End of Trial StatusOngoing
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