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    The EU Clinical Trials Register currently displays   37236   clinical trials with a EudraCT protocol, of which   6125   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2016-002766-31
    Sponsor's Protocol Code Number:BI1200.277
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-05-16
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-002766-31
    A.3Full title of the trial
    A phase 2, single arm, European multi-center trial evaluating the efficacy of afatinib as first-line or later-line treatment in advanced chordoma.
    Een Europees, multicenter, fase 2 onderzoek naar de effectiviteit van afatinib als eerste- of latere lijn behandeling van gevorderd chordoom.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Afatinib in patients with advanced chordoma.
    Afatinib bij patiënten met gevorderd chordoom.
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberBI1200.277
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03083678
    A.5.4Other Identifiers
    Name:Boehringer Ingelheim protocol numberNumber:1200.277
    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 SponsorLeiden University Medical Center
    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 supportBoehringer Ingelheim
    B.4.1Name of organisation providing supportChordoma Foundation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointResearch secretary
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2300 RC
    B.5.4Telephone number+310715261093
    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 Yes
    D. name Giotrif
    D. of the Marketing Authorisation holderBoehringer Ingelheim
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Metastatic or unresectable chordoma
    Gemetastaseerd of niet resectabel chordoom
    E.1.1.1Medical condition in easily understood language
    Advanced chordoma
    Gevorderd chordoom
    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 PT
    E.1.2Classification code 10008747
    E.1.2Term Chordoma
    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 treatment efficacy by progression free survival (PFS) according to RECIST 1.1.
    - Quality of life assessment
    - Evalueren van effectiviteit van behandeling dmv progressie vrije overleving
    - Kwaliteit van leven assessment
    E.2.2Secondary objectives of the trial
    - To evaluate the treatment efficacy by growth modulation index
    - To evaluate the safety and tolerability of afatinib in chordoma
    - To determine the overall survival after start of treatment
    - Evalueren van effectiviteit van behandeling dmv de 'growth modulation index'
    - Evalueren van veiligheid en verdraagbaarheid van afatinib in chordoma
    - Bepalen van overleving na start behandeling
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Translational research objectives:
    - To evaluate whether EGFR pathway and genetic alterations of pre-treatment tumor material correlates with outcome in patients treated with afatinib
    - To evaluate circulating predictive and prognostic biomarkers in patients treated with afatinib

    Pharmacokinetic objectives:
    - To explore the population pharmacokinetics, pharmacogenetics and dynamics of afatinib in metastatic or unresectable chordoma.
    o To develop a population pharmacokinetics (PK) / pharmacodynamics (PD) / pharmacogenetic (PG) model using non-linear mixed effects modeling (NONMEM)
    o To develop a limited sampling model able to accurately predict afatinib exposure with a limited amount of blood samples
    o To develop a time to event model based on the collected data to be able to simulate optimal dosing strategies for afatinib in metastatic or unresectable chordoma patients
    o To model tumor imaging data (growth or shrinkage) in relationship to afatinib exposure and genetic data of the tumor
    Translationeel onderzoek studiedoelen:
    - EGFR route en genetische veranderingen evalueren in tumormateriaal afgenomen voor start behandeling om te correleren met uitkomsten in patienten na behandeling met afatinib
    - Evalueren van circulerende predictieve en prognostische biomarkers in patienten na behandeling met afatinib

    Farmacokinetiek studiedoelen:
    - Exploreren van populatie farmacokinetiek (PK), farmacogenetica (PG) en farmacodynamiek (PD) van afatinib in gevorderd chordoom
    o Ontwikkelen van een PK/PG/PD model dmv een nonlineair mixed effects model (NONMEM)
    o Ontwikkelen van beperkt afname model om nauwkeurig afatinib blootstelling te bepalen met een beperkt aantal bloedafnames
    o Ontwikkelen van een 'tijd tot event' model gebaseerd op verzamelde data om optimale doseerstrategieen voor afatinib te simuleren
    o Modelleren van uitslagen van beeldvorming (tumorgroei of krimp) in relatie tot afatinib blootstelling en genetische tumorgegevens
    E.3Principal inclusion criteria
    - Locally advanced or metastatic, pathologically proven, EGFR expressing chordoma, not amenable for local therapies
    - Patients of 18 years and up
    - Documented radiographic progression of disease according to RECIST 1.1 criteria in last 6 months
    - ECOG Performance status ≤ 2
    - Adequate bone marrow function (Hb ≥ 6.0 mmol/L, absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥ 75 x 109/L)
    - An adequate renal function with GFR ≥ 45 ml/min calculated by Cockroft-Gault formula
    - Total Bilirubin ≤ 1.5 times upper limit of normal (ULN) (Patients with Gilbert’s syndrome total bilirubin must be ≤4 times institutional upper limit of normal).
    - Aspartate amino transferase (AST) or alanine amino transferase (ALT) ≤ 3 times ULN (if related to liver metastases ≤ 5 times ULN)
    - Ability to swallow medication
    - Recovered from any previous therapy related toxicity to ≤ grade 1 at study entry (except for stable sensory neuropathy ≤ grade 2 and alopecia)
    - Availability of archival tumor material for central review (if not please obtain a new tumor biopsy)
    - Written signed informed consent
    - Ability to adhere to the study visits and all protocol requirements
    - Lokaal gevorderd of gemetastaseerd chordoom, PA bewezen met EGFR expressie, niet beschikt voor lokale therapie
    - Patienten van 18 jaar of ouder
    - Gedocumenteerde radiologische ziekteprogressie volgens RECIST 1.1 criteria in de 6 maanden voorafgaand aan studiedeelname
    - ECOG performance status ≤ 2
    - Adequate beenmergfunctie (Hb ≥ 6.0 mmol/L, neutrofielen ≥ 1.5 x 109/L, trombocyten ≥ 75 x 109/L)
    - Adequate nierfunctie met GFR ≥ 45 ml/min volgens de Cockroft-Gault formule
    - Totaal bilirubine ≤ 1.5 keer bovengrens van normaal (Voor patienten met het syndroom van Gilbert is een totaal bilirubine van ≤ 4 keer bovengrens van normaal vereist)
    - Aspartaat amino transferase (ASAT) of alanine amino transferase (ALAT) ≤ 3 keer bovengrens van normaal (indien gerelateerd aan levermetastasen ≤ 5 keer bovengrens van normaal)
    - In staat om medicatie door te slikken
    - Hersteld van bijwerkingen als gevolg van eerdere behandeling tot ≤ graad 1 op het moment van start van de studie (met als uitzondering stabiele sensibele neuropathie ≤ graad 2 en alopecia)
    - Beschikbaarheid van gearchiveerd tumormateriaal voor centrale beoordeling (nieuw biopt vereist indien niet beschikbaar)
    - Schriftelijk informed consent
    - Vermogen om studiebezoeken af te leggen en te voldoen aan de vereisten zoals geformuleerd in het studieprotocol
    E.4Principal exclusion criteria
    - Life expectancy of less than 3 months
    - No measurable lesions according to RECIST 1.1
    - Known hypersensitivity to afatinib
    - Major surgery less than 4 weeks prior to start of treatment
    - Previous treatment with any other investigational agents within 14 days of first day of study drug dosing
    - History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure NYHA classification of ≥ 3, unstable angina or poorly controlled arrhythmia as determined by the investigator. Myocardial infarction within 6 months prior to inclusion.
    - Known pre-existing interstitial lung disease
    - Any history or presence of poorly controlled gastrointestinal disorders that could affect the absorption of the study drug (e.g. Crohn’s disease, ulcerative colitis, chronic diarrhea, malabsorption)
    - Known active hepatitis B infection (defined as presence of HepB sAg and/ or Hep B DNA), active hepatitis C infection (defined as presence of Hep C RNA) and/or known HIV carrier.
    - Systemic anti-cancer therapy within 28 days prior to the first dose of study drug , or radiotherapy to an index (or target)lesion within 21 days prior to the first dose of study drug
    - Requiring treatment with any of the prohibited concomitant medications listed in Section 6.3.9 that cannot be stopped for the duration of trial participation
    - Pregnant or lactating women
    - Other invasive malignancies diagnosed within the last 5 years, except non-melanoma skin cancer and localized cured prostate and cervical cancer
    - Any history of or concomitant condition that, in the opinion of the Investigator, would compromise the patient’s ability to comply with the study or interfere with the evaluation of the efficacy and safety of the test drug
    - Levensverwachting van minder dan 3 maanden
    - Afwezigheid van meetbare lesies volgens RECIST 1.1 criteria
    - Bekende overgevoeligheid voor afatinib
    - Grote operatie minder dan 4 weken voor start van studiedeelname
    - Behandeling met experimentele middelen in de 14 dagen voorafgaand aan start van studie
    - Voorgeschiedenis of aanwezigheid van hartfalen NYHA klasse ≥ 3, niet stabiele angina pectoris of onvoldoende gereguleerde aritmieen in de opinie van de onderzoeker. Myocardinfarct binnen 6 maanden voorafgaand aan inclusie
    - Bekende pre-existente interstitiele longziekte
    - Voorgeschiedenis of aanwezigheid van onvoldoende gereguleerde gastrointestinale ziekten die de opname van studiemedicatie in de darm kunnen beinvloeden (bv. de ziekte van Crohn, colitis ulcerosa, chronische diarree, malabsorptie)
    - Bekende actieve hepatitis B infectie (gedefinieerd als aanwezigheid van HepB sAg en/of Hep B DNA), actieve hepatitis C infectie (gedefinieerd als aanwezigheid van Hep C RNA) en/of bekende HIV drager
    - Behandeling met systemische antineoplastische behandeling binnen 28 dagen voorafgaand aan eerste dosis studiemedicatie, of radiotherapie op een index (of target)lesie binnen 21 dagen voorafgaand aan eerste dosis studiemedicatie
    - Noodzakelijke behandeling met één van de medicamenten uit de lijst met niet toegestane medicamenten tijdens de studie in protocol sectie 6.3.9, welke niet gestaakt kan worden gedurende deelname aan deze studie
    - Zwangere vrouwen of vrouwen die borstvoeding geven
    - Andere invasieve maligniteiten gediagnosticeerd in de afgelopen 5 jaar, met uitzondering van niet-melanomateuze huidkanker en lokaal en volledig gereseceerd cervix- en prostaatkanker
    - Voorgeschiedenis of aanwezigheid van aandoeningen die, naar mening van de onderzoeker, een adequate studiedeelname compromitteren of de effectiviteitsevaluatie of veiligheid van de studiemedicatie verstoren
    E.5 End points
    E.5.1Primary end point(s)
    - PFS ≥ 12 months in first line treatment and ≥ 9 months in further line treatment
    - Change from baseline in EORTC QLQ-C30 questionnaire / Brief pain inventory score
    - PFS ≥ 12 maanden in eerstelijns behandeling en ≥ 9 maanden in latere lijn behandeling
    - Verandering tov baseline op EORTC QLC-C30 en Brief pain questionnaire short form vragenlijst scores
    E.5.1.1Timepoint(s) of evaluation of this end point
    - PFS is evaluated at time point of progressive disease (goal PFS > 12 months for first-line treatment and > 9 months for later-line treatment, imaging every 12 weeks), evaluation throughout complete study
    - Questionnaire scores measured every 8 weeks during afatinib treatment compared to baseline, until progression / withdrawal (no set time limit), evaluation after 1 year
    - Progressie vrije overleving wordt bepaald/geevalueerd op moment van ziekteprogressie onder afatinib (doel > 12 maanden voor eerstelijns behandeling en > 9 maanden voor latere lijn behandeling, elke 12 weken beeldvorming), evaluatie tijdens gehele studie
    - Vragenlijst scores elke 8 weken gemeten gedurende de studie vergeleken met baseline, tot aan progressie / einde deelname (geen maximum tijdslimiet), evaluatie na 1 jaar
    E.5.2Secondary end point(s)
    Secondary endpoints
    - Time to progression during afatinib treatment (TTP2) divided by time to progression before start of this treatment TTP1 (= growth modulation index)
    - Toxicity determined by CTCAE v 4.03 criteria
    - Overall survival from start of afatinib treatment

    Exploratory endpoints
    - EGFR pathway and dimerization analysis in archival tumor tissue
    - Genome sequence analysis of available tumor samples
    - Analysis of circulating biomarkers in patients pre and post treatment
    - Observed afatinib plasma levels, administered afatinib doses and time between afatinib doses and sampling. Used to construct:
    o a population PK / PD / PG model
    o a limited sampling model for afatinib exposure
    o a time to event model
    o tumor imaging data in relationship to afatinib exposure and genetic data of the tumor.
    Secundaire eindpunten
    - 'Growth modulation index' gedefinieerd als; tijd tot progressie onder afatinib behandeling (TTP2) gedeeld door tijd tot progressie onder voorgaande behandeling (TTP1)
    - Toxiciteit volgens CTCAE versie 4.03 criteria
    - Overleving vanaf start van afatinib behandeling

    Verkennende eindpunten
    - EGFR route en dimerisatie analyse in gearchiveerd tumorweefsel
    - Genoomsequentie analyse in beschikbare tumorweefsels
    - Analyse van circulerende biomarkers in patienten voor en na behandeling met afatinib
    - Geobserveerde afatinib spiegels, toegediende afatinib doseringen en tijd tussen dosering en bloedafname, voor het construeren van
    * een populatie PK/PG/PD model
    * een beperkt afname model voor afatinib blootstelling
    * een 'tijd tot event' model
    * beeldvorming uitslagen in relatie tot afatinib blootstelling en genetische tumorgegevens
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints
    - Growth modulation is evaluated at time point of progressive disease (imaging every 12 weeks, , evaluation throughout complete study)
    - Toxicity evaluated continuously during study (every 4 weeks), until progression / withdrawal
    - Overall survival evaluated at time of death (during trial and during follow-up period every 3 months for total 3 years follow-up)

    Translational research endpoints:
    - Blood samples and requesting archival tumor tissue and optinal extra tumor biopsy at baseline, during study blood withdrawals for circulating biomarkers and tumor DNA at baseline, cycle 4 day 1 (C4D1), C7D1 and at progression / withdrawal.

    Pharmacokinetic endpoints:
    - PK withdrawals at C1D1, C1D15, C3D1, C5D1 (total 12 withdrawals)
    - GMI geevalueerd op moment van ziekteprogressie onder afatinib (beeldvorming elke 12 weken), evaluatie tijdens gehele studie
    - Toxiciteit wordt continue gemonitord/geevalueerd gedurende studie (á 4 weken), tot aan progressie / einde deelname
    - Overleving wordt geevalueerd op moment van overlijden (gedurende onderzoek en tijdens follow-up elke 3 maanden gedurende 3 jaar totale follow-up

    Translationeel onderzoek eindpunten
    - Bloedafnames en opvragen gearchiveerd tumorweefsel en optioneel extra tumorbiopt op baseline, tijdens studie elke 12 weken bloedafnames voor circulende biomarker / tumor DNA analyse, op baseline, C4D1, C7D1, bij progressie / einde deelname

    Farmacokinetisch onderzoek eindpunten
    - PK afnames op C1D1, C1D15, C3D1 en C5D1 (totaal 12 afnames)
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    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. 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 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 is considered to be the last visit of the last patient on-study. Patients will be followed for an additional 3 years for survival.
    Het einde van de studie is het laatste bezoek van de laatste patient. Patienten zullen vervolgd tot 3 jaar na stop behandeling.
    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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 Yes
    F. of other specific vulnerable populations
    patients with incurable disease
    patienten met ongeneeslijke ziekte
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    Follow-up for survival for 3 years after stop afatinib. After that no specific treatment or care planned.
    Follow-up voor overlevingsdata tot 3 jaar na stop afatinib. Hierna geen specifieke behandeling of zorg gepland.
    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 Decision2017-05-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-29
    P. End of Trial
    P.End of Trial StatusOngoing
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