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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   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).

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    Summary
    EudraCT Number:2019-001833-14
    Sponsor's Protocol Code Number:EAURF2018-02
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-09-28
    Trial results View 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 ConcernedFrance - ANSM
    A.2EudraCT number2019-001833-14
    A.3Full title of the trial
    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 have received radical surgery. A European Association of Urology Research Foundation Phase II Clinical Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study evaluating safety and efficacy of Pemigatinib drug as post-operative therapy for selected, high-risk patients with urothelial carcinoma who have received radical surgery. A European Association of Urology Research Foundation clinical trial
    A.3.2Name or abbreviated title of the trial where available
    Adjuvant Pemigatinib in surgically treated high-risk UC
    A.4.1Sponsor's protocol code numberEAURF2018-02
    A.5.4Other Identifiers
    Name:AcronymNumber:PEGASUS
    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 SponsorEAU Research Foundation
    B.1.3.4CountryNetherlands
    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 supportIncyte Biosciences International Sàrl
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAMS Advanced Medical Services GmbH
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressAm Exerzierplatz 2
    B.5.3.2Town/ cityMannheim
    B.5.3.3Post code68167
    B.5.3.4CountryGermany
    B.5.4Telephone number+4962170095100
    B.5.5Fax number+4962170095140
    B.5.6E-mailregulatoryaffairsDE@ams-europe.com
    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 namePemigatinib
    D.3.2Product code [Pemigatinib]
    D.3.4Pharmaceutical form 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 INNPemigatinib
    D.3.9.1CAS number 1513857-77-6
    D.3.9.2Current sponsor codePemigatinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.5
    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 namePemigatinib
    D.3.2Product code [Pemigatinib]
    D.3.4Pharmaceutical form 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 INNPemigatinib
    D.3.9.1CAS number 1513857-77-6
    D.3.9.2Current sponsor codePemigatinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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
    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 neoadjuvant cisplatin-based chemotherapy or, if neoadjuvant chemotherapy was not administered, ineligible to receive cisplatin-based adjuvant chemotherapy, with evidence of FGFR3 alterations
    E.1.1.1Medical condition in easily understood language
    Urothelial tumor treated with at least three cycles of cisplatin-based chemotherapy after surgery or unfit to receive cisplatin-based chemotherapy, with evidence of alterations in the FGFR3 gene
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10046714
    E.1.2Term Urothelial carcinoma bladder
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate 2-year relapse free survival rate of high-risk patients previously treated with cisplatin-based chemotherapy or ineligibility to receive cisplatin-based adjuvant chemotherapy
    E.2.2Secondary objectives of the trial
    Secondary objectives are to evaluate safety, tolerability and overall survival.
    An explorative objective is to evaluate biomarkers of clinical benefit and prognostic biomarkers. These biomarkers will be evaluated at the time of radical surgery, on the tumor tissue, before the administration of the study drug
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Men and woman, aged 18 years or older with histological evidence of pT3-4 and/or pN1-3 urothelial cancer (UC) of the urinary bladder or upper urinary tract after radical cystectomy/radical nephroureterectomy. Patients with mixed histologies are required to have a dominant (i.e. at least 50%) urothelial cell carcinoma pattern
    2. Previous administration of at least 3 cycles of neoadjuvant cisplatin-based chemotherapy OR, if neoadjuvant chemotherapy was not administered, ineligibility to receive cisplatin-based adjuvant chemotherapy based on Galsky’s criteria, that include at least one of the following: (1) WHO performance status = 2 and/or (2) creatinine-clearance < 60 ml/min and/or (3) CTCAE Gr= 2 hearing loss and/or (4) CTCAE Gr = 2 neuropathy
    3. Evidence of FGFR3 alterations (mutations or gene fusions as specified in protocol) as assessed by a centralized Foundation Medicine test (Foundation One CDx assay). A list of the allowed FGFR alterations is provided the study protocol
    4. Recovered with no evidence of disease confirmed by radiological images, prior to start of adjuvant therapy within 13 weeks after radical surgery
    5. WHO performance status of 0, 1 or 2
    6. Willingness to avoid pregnancy or fathering children. If the patient is male, he must use a condom during sexual intercourse during the treatment period and 240 days thereafter (120 days to eliminate study treatment and 120 days spermatogenesis cycle) plus partner use of a contraceptive method with a failure rate of <1% per year (See Appendix 1 of the protocol). If the patient is female, and of childbearing potential, she must practice adequate contraception (Appendix 1 of the study protocol)
    for 30 days prior to administration of study treatment, have a negative pregnancy test and continue such precautions during the study treatment period and for 150 days after the last study treatment (120 days to eliminate study treatment and 30 days menstruation cycle) (See Appendix 1 of the study protocol for standards of adequate contraceptive methods)
    7. Written informed consent for screening of tumor tissue and if evidence of FGFR alterations written informed consent for the start of the complete study
    E.4Principal exclusion criteria
    1. Any previous receipt of a selective FGFR inhibitor
    2. Presence of primary CIS only
    3. Presence of another malignancy in the 3 years before enrolment except for basal cell carcinoma or squamous cell carcinoma of the skin, cis of cervix, localised prostate cancer in active surveillance or other non invasive or other indolent malignancy that has undergone potentially curative therapy
    4. Presence of pregnancy or lactation or not willing to avoid pregnancy or fathering children
    5. Distant metastases (M1 disease) or presence of radiological evidence of disease at baseline
    6. Treatment with other investigational drugs, receipt of anticancer medications or radiotherapy of the bladder or upper urinary tract prior to- or after radical surgery
    7. Use of any potent CYP3A4 inhibitors or inducers within 14 days or 5 half lives (whichever is longer) before the first dose of study Tx
    8. Abnormal laboratory parameters:
    - Total bilirubin = 1.5 × upper limit of normal (ULN; = 2.5 × ULN if Gilbert syndrome);
    - AST and/or ALT > 2.5 × ULN;
    - Creatinine clearance = 30 mL/min based on Cockroft-Gault;
    - Serum phosphate > institutional ULN;
    - Serum calcium outside of the institutional normal range or serum albumin-corrected calcium outside of the institutional normal range when serum albumin is outside of the institutional normal range
    9. History of human immunodeficiency virus infection or active tuberculosis infection
    10. Diagnosis of immunodeficiency or receiving chronic systemic steroid therapy (exceeding >10 mg daily of prednison equivalent; inhalation steroids are permitted)
    11. Evidence of hepatitis B virus or hepatitis C virus active infection or risk of reactivation
    12. History of clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months from enrollment, NYHA Class III or IV (Appendix 4 of the Protocol)
    13. Current evidence of corneal disorder/keratopathy (including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, keratoconjunctivitis, etc) or retinal disorder (including but not limited to, central serous retinopathy, macular/retinal degeneration, diabetic retino-pathy, retinal detachment, etc) as confirmed by ophthalmologic examination
    14. Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study drug and attending the required study visits
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the 2-year relapse free survival rate. Relapse free survival is defined as the time from the date of start of study treatment until disease
    relapse or progression by Investigator determination, or death due to any cause, whichever occurs first
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be evaluated at 2 years from the first dose of study drug
    E.5.2Secondary end point(s)
    Overall survival. Overall Survival (OS) is defined as the time from the date of start of study treatment to death due to any cause; Safety of study drug assessed as incidence and severity of side effects and changes in laboratory values; An explorative objective is to evaluate biomarkers of clinical benefit and prognostic biomarkers.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall survival will be assessed from the date of start of study treatment until death, withdrawal of consent, or the end of the study, whichever occurs first; Adverse event information will be collected from the start of study treatment up to the visit scheduled 30-35 days after the end of study treatment; Biomarkers will be evaluated at the time of radical surgery, on the tumor tissue, before the administration of the study drug
    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 No
    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 No
    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.8.2.4Number of treatment arms in the trial1
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    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
    The end of the study will be the timepoint when all subjects have discontinued the study after 2 years of follow-up or when the sponsor terminates the study
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 56
    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 monitored and treated according to local clinical practice
    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 Decision2020-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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