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    Summary
    EudraCT Number:2016-003121-42
    Sponsor's Protocol Code Number:CHDR1635
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-11-08
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-003121-42
    A.3Full title of the trial
    A Phase I-IIa, Open label, Dose Escalating Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Intravenous Pegylated Liposomal Dexamethasone Sodium Phosphate as Monotherapy in Patients with Metastatic Prostate Cancer
    Fase I-IIa, open, oplopende doseringsstudie, ter evaluatie van de veiligheid, pharmacokinetiek, pharmacodynamiek van intraveneus toegediend liposomaal verpakt dexamethason zoutfosfaat als monotherapie bij patienten met gemetastaseerd prostaatcarcinoom.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study investigating intravenously administrated Oncocort in patients with metastatic prostate cancer
    Studie naar de veiligheid en werking van oncocort bij patienten met uitgezaaide prostaatkanker.
    A.3.2Name or abbreviated title of the trial where available
    Intravenous liposomal dexamethasone monotherapy in patients with metastatic prostate cancer
    Intraveneus liposomaal dexamethason monotherapie bij patienten met gemetastaseerd prostaatcarcinoom
    A.4.1Sponsor's protocol code numberCHDR1635
    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 SponsorEnceladus Pharmaceuticals BV
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEnceladus
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre for human drug research
    B.5.2Functional name of contact pointCRO
    B.5.3 Address:
    B.5.3.1Street AddressZernikedreef 8
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CL
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31717517163
    B.5.6E-mailtrials@chdr.nl
    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 nameOncocort
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEG-liposomal dexamethasone sodium phosphate
    D.3.9.1CAS number 125-02-0
    D.3.9.2Current sponsor codeOncocort
    D.3.9.3Other descriptive namea liposomal formulation of dexamethasone sodium phosphate intended for slow intravenous administration
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 40
    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
    Castration resistant prostate cancer with bone metastases.
    Naar de botten gemetastaseerd prostaatcarcinoom, resistent voor hormoontherapie.
    E.1.1.1Medical condition in easily understood language
    Metastasized prostate cancer
    Naar de botten uitgezaaid prostaatkanker
    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 10062904
    E.1.2Term Hormone-refractory prostate 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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety, tolerability, pharmacokinetics and pharmacodynamic effects of liposomal dexamethasone (Oncocort™) in patients with metastatic prostate cancer.
    Tolerantie, veiligheid en farmacokinetiek van oncocort bepalen bij patienten met gemetastaseerd prostaatkanker.
    E.2.2Secondary objectives of the trial
    To determine pharmacodynamic effects of liposomal dexamethasone (Oncocort) in patients with metastatic prostate cancer.
    Farmacodynamische effecten van oncocort bepalen bij patienten met gemetastaseerd prostaatkanker.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adult patients with mCRPC and one or more metastases in the bone, confirmed by bone scintigraphy, MRI or CT-scan within 6 weeks before first dosage;
    2. Able to participate, and willing to give written informed consent and to comply with the study restrictions;
    3. Body mass index (BMI) of 18 kg/m2 or higher (inclusive) and a minimum weight of 50 kg;
    1. Volwassen patiënten met mCRPC en één of meer metastasen in het bot bevestigd door botscan, MRI of CT-scan binnen 6 weken vóór de eerste dosis;
    2. In staat om deel te nemen, en bereid zijn om schriftelijke geïnformeerde toestemming te geven en te voldoen aan de studie beperkingen;
    3. Body mass index (BMI) van 18 kg / m2 of meer (inclusief) en een minimum gewicht van 50 kg;
    E.4Principal exclusion criteria
    1. Concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
    2. Contraindication for glucocorticoids as judged by investigator
    3. Use of systemic glucocorticosteroids within 4 weeks before first dosage, with exception of topical and inhalation steroids.
    4. Any confirmed and clinically significant allergic reactions (urticaria or anaphylaxis, non-active hay fever is acceptable). Allergy or hypersensitivity against any drug, including any component of the study drug, biologic therapy or IV radiocontrast agent.
    5. Clinically significant abnormalities, as judged by the investigator, following a detailed medical history, a physical examination including vital signs, 12-lead ECG and laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant.
    6. History or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder that may aggravate due to study participation and jeopardize the health status of the patient.
    7. Any infection within 1 month prior to the anticipated dosing day.
    8. Any indication of past or present tuberculosis.
    9. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
    10. History of alcohol or substance abuse
    11. Use of CYP3A4-inhibiting drugs or food (grapefruit, grapefruit juice, grapefruit-containing products, Seville oranges, or pomelo-containing products, and quinine containing drinks within 14 days prior to day –1.
    12. Participation in an investigational drug or device study within 3 months prior to screening.
    13. Donation of blood over 500 mL within three months prior to screening.
    14. Vaccination within 6 weeks prior to start of treatment or planned vaccination up to 90 days after the final dose.
    15. Unwillingness or inability to comply with the study protocol for any other reason.
    1. Gelijktijdige ziekte of aandoening die kunnen interfereren met, of waarvoor de behandeling kan interfereren met de uitvoering van het onderzoek, of dat zou, naar het oordeel van de onderzoeker, een onaanvaardbaar risico voor het onderwerp in deze studie vormen.
    2. contra-indicatie voor glucocorticoïden zoals beoordeeld door de onderzoeker
    3. Gebruik van systemische glucocorticosteroïden binnen 4 weken vóór de eerste dosis, met uitzondering van de actuele en inademing steroïden.
    4. Elke bevestigd en klinisch significante allergische reacties (urticaria of anafylaxie, non-actief hooikoorts is acceptabel). Allergie of overgevoeligheid tegen drugs, met inbegrip van componenten van het onderzoeksgeneesmiddel, biologische therapie of IV radiocontrast middel.
    5. Klinisch significante afwijkingen, zoals beoordeeld door de onderzoeker, na een gedetailleerde medische voorgeschiedenis, een lichamelijk onderzoek met vitale tekenen, 12-lead ECG en laboratoriumonderzoek (met inbegrip van de lever en de nieren panelen, complete bloedbeeld, chemie panel en urineonderzoek). In het geval van onzekere of twijfelachtige resultaten, kunnen de tests uitgevoerd tijdens screening worden herhaald voordat randomisatie om de geschiktheid te bevestigen of dat klinisch niet relevant.
    6. History of symptomen van belangrijke ziekten, waaronder (maar niet beperkt tot), neurologische, psychiatrische, endocriene, hart-, ademhalings-, maag-, lever-, nier- of aandoening die het gevolg kunnen verergeren om de participatie te bestuderen en in gevaar brengen van de gezondheid van de patiënt.
    7. infectie binnen 1 maand voor de verwachte dosering dag.
    8. Elke indicatie van heden of verleden tuberculose.
    9. De positieve Hepatitis B oppervlakteantigeen (HBsAg), hepatitis C antilichaam (HCV Ab), of humaan immunodeficiëntievirus antilichaam (Ab HIV) bij de screening.
    10. Geschiedenis van alcohol of drugsmisbruik
    11. Gebruik van CYP3A4-remmende medicijnen of voedsel (grapefruit, grapefruitsap, grapefruit-bevattende producten, Sevilla sinaasappels, of pomelo bevattende producten, en kinine bevattende dranken binnen 14 dagen voorafgaand aan de dag -1.
    12. Deelname aan een experimenteel medicijn of apparaat studie binnen de 3 maanden voorafgaand aan de screening.
    13. Schenking van het bloed meer dan 500 ml binnen de drie maanden voorafgaand aan de screening.
    14. Vaccinatie binnen 6 weken voor aanvang van de behandeling of geplande vaccinatie tot 90 dagen na de laatste dosis.
    15. onwil of het onvermogen om te voldoen aan de studie protocol om een ​​andere reden.
    E.5 End points
    E.5.1Primary end point(s)
    Standard safety and tolerability measurements are listed below, and will be assessed according to the visit- and assessment schedule (Table 2).
    - Concomitant medication
    - Clinical laboratory tests (Haematology / Chemistry / Urinalysis)
    - Complement activation
    - Vital signs (Pulse Rate, Blood pressure, Temperature)
    - Electrocardiogram (HR, PR, QRS, QT)

    If indicated additional diagnostics will be performed and treatment-emergent (serious) adverse events ((S)AEs) will be registered.
    Standard veiligheid en verdraagbaarheid metingen worden hieronder vermeld, en zal worden getoetst aan de bezoek- en evaluatie schema (tabel 2).
    - Gelijktijdig toegediende medicatie
    - Klinische laboratoriumtests (Hematologie / Chemie / Urineonderzoek)
    - complement activatie
    - De vitale functies (hartslag, bloeddruk, temperatuur)
    - elektrocardiogram (HR, PR, QRS, QT, QTcB / F)

    Als aangegeven aanvullende diagnostiek wordt uitgevoerd of behandeling plaatsvindt, worden (ernstige) bijwerkingen ((S) AES) geregistreerd.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evaluation of safety and tolerability will be assessed at least 4 days after dosing the first subject, before continuation to the next dose and start of the remaining subjects.
    Additional safety and tolerability parameters will be evaluated throughout the study and will be reported afterwards.
    Evaluatie van veiligheid en verdraagbaarheid wordt beoordeeld tenminste 4 dagen na de eerste toediening toegepast voordat vervolg op de volgende dosis en start de andere vakken.
    Additionele parameters veiligheid en verdraagbaarheid zal de gehele studie geëvalueerd en worden daarna gerapporteerd.
    E.5.2Secondary end point(s)
    Pharmacokinetic endpoints
    The following endpoints will be determined and will be measured as according to the visit- and assessment schedule for liposomal and free dexamathosone following each treatment. They will be derived by non-compartmental analysis of the plasma concentration-time data:
    - The maximum concentration (Cmax)
    - The time to reach maximum plasma concentration (tmax);
    - The area under the concentration-time curve from zero to t of the last measured concentration above the limit of quantification (AUC0-last)
    - The terminal disposition rate constant (λz) with the respective half-life (t½).
    - The area under the concentration-time curve from zero to infinity(AUC0-inf).

    Other parameters, including Vz, CL, and other parameters as appropriate, as well as dose adjusted parameters, may be determined.

    Pharmacodynamic effect endpoints
    Absolute values and change from baseline to each time point of measurement will be summarized using individual values or summated response measures (e.g. AUC).
    - PSA;
    - Alkaline phosphatase
    - Cortisole
    - Sex steroids (testosterone, estradiol, FSH, LH and SHBG);
    - Fasting blood glucose;
    - Lymphocyte count;
    - Activation of complement
    - Comprehensiveness of bone metastases, as assessed in Scintigraphy/CT/MRI;
    farmacokinetische eindpunten
    De volgende eindpunten zullen worden bepaald en zal worden gemeten volgens de bezoek- en evaluatie schema voor liposomaal en vrije dexamathosone na elke behandeling. Zij worden verkregen door niet-compartimentele analyse van de plasmaconcentratie-tijd data:
    - De maximale concentratie (Cmax)
    - De tijd tot de maximale plasmaconcentratie (Tmax) te bereiken;
    - Het gebied onder de concentratie-tijd-curve van nul tot t van de laatst gemeten concentratie boven de limiet van kwantificering (AUC0-last)
    - De terminal dispositie snelheidsconstante (Az) met de respectievelijke halfwaardetijd (t½).
    - Het oppervlak onder de concentratie-tijd curve van nul tot oneindig (AUC0-inf).

    Andere parameters, zoals Vz, CL, en andere parameters indien nodig, en parameters dosering aangepast kunnen worden bepaald.

    Farmacodynamische effect eindpunten
    Absolute waarden en verandering vanaf baseline tot elk tijdstip van de meting zal worden samengevat met behulp van afzonderlijke waarden of gesommeerd bestrijdingsmaatregelen (bijvoorbeeld AUC).
    - PSA;
    - Alkalische fosfatase;
    - Cortisol
    - Sex steroïden (testosteron, estradiol, FSH, LH en SHBG);
    - Nuchtere bloedglucose;
    - Aantal lymfocyten;
    - Activering van complement
    - Uitbreiding van botmetastasen, zoals beoordeeld Scintigrafie / CT / MRI;
    E.5.2.1Timepoint(s) of evaluation of this end point
    Pharmacokinetec endpoints will be evaluated after phase 1, and again at end of study
    All other secondary end points will be evaluated at the end of study.
    Farmacokinetische eindpunten zullen worden geëvalueerd na fase 1, en opnieuw aan het einde van de studie
    Alle andere secundaire eindpunten zullen worden geëvalueerd aan het einde van de studie.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Laatste bezoek van laatste proefpersoon
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 10
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state10
    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 followed up by their oncologist after participation in the study and if necessary during the study.
    Na de studie worden patienten teruggezien door hun oncoloog in het LUMC. Zo nodig worden zij ook tijdens de studie door de oncoloog vervolgd.
    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 Decision2016-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-09
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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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