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    Summary
    EudraCT Number:2016-002993-11
    Sponsor's Protocol Code Number:2016-02
    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: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 number2016-002993-11
    A.3Full title of the trial
    A single arm phase 2 multicenter study determining the response to Cabazitaxel in metastatic prostate cancer (mCRPC) patients with AR-V7 positive circulating tumor cells (CTCs)
    Fase 2 multicentrische eenarmige studie naar de respons op cabazitaxel in patiënten met gemetastaseerd castratieresistent prostaatcarcinoom en AR-V7 positieve circulerende tumorcellen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cabazitaxel in metastatic prostate cancer patients with AR-V7 positive CTCs
    Cabazitaxel in gemetastaseerd CRPC patiënten met AR-V7 positieve CTC’s
    A.3.2Name or abbreviated title of the trial where available
    CABA-V7
    A.4.1Sponsor's protocol code number2016-02
    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 SponsorErasmus MC Cancer Institute
    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 supportSanofi-aventis
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC cancer institute
    B.5.2Functional name of contact pointClinical Trial Center
    B.5.3 Address:
    B.5.3.1Street Address's Gravendijkwal 230
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 CE
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031107041560
    B.5.6E-mailsecretariaatctc@erasmusmc.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 Yes
    D.2.1.1.1Trade name Cabazitaxel
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-aventis groupe
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 Concentrate and solvent for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous 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.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
    metastatic castration-resistant prostate cancer
    gemetastaseerd castratieresistent prostaatcarcinoom
    E.1.1.1Medical condition in easily understood language
    metastatic prostate cancer not responsive to castration therapy
    uitgezaaide prostaatkanker resistent voor castratie
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Explore the PSA response rate to cabazitaxel in mCRPC patients who have progressed to docetaxel and have detectable AR-V7 expression in CTCs
    Het primaire doel van deze studie is om te exploreren wat de PSA respons op cabazitaxel is in mCRPC patiënten die progressie hebben getoond op docetaxel en die AR-V7 positieve CTCs hebben
    E.2.2Secondary objectives of the trial
    PSA response to third-line cabazitaxel after enzalutamide or abiraterone treatment, toxicity of cabazitaxel in second and third-line treatment, as well as cabazitaxel pharmacokinetics in relation to response. We will explore associations between other AR splice variants and response to cabazitaxel treatment. We will also explore differences in AR splice variant expression before and after therapy, to gain insight into possible mechanisms of resistance and means to predict treatment resistance at an early time point. In addition, we will analyze cfDNA for dynamic changes during treatment and tumor-specific mutations.
    PSA respons in derdelijns cabazitaxel behandeling, de toxiciteit van tweede vs. derdelijns cabazitaxel behandeling en de farmacokinetiek van cabazitaxel gerelateerd aan respons. Er wordt ook gekeken naar de associaties van andere AR splice variants en de response op cabazitaxel, het verschil tussen AR splice variant voor en tijdens therapie, om inzicht te krijgen in de mechanismes van resistentie en om resistentie voor behandeling vroegtijdig te kunnen voorspellen. Ook analyseren we cfDNA veranderingen tijdens behandeling en tumorspecifieke mutaties.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Histologically or cytologically confirmed adenocarcinoma of the prostate
    without neuroendocrine differentiation or small cell features.
    - Continued androgen deprivation therapy either by LHRH
    agonists/antagonists or orchiectomy.
    - Serum testosterone <50 ng/ml (1.7 nmol/L) within 21 days of
    treatment arm allocation.
    - Age ≥18 years
    progression for study entry is defined as one or more of the following
    criteria:
    • At least 3 consecutive PSA rises over a reference value, with an
    interval of ≥ 1 week between each determination. PSA at screening visit
    should be ≥ 2.0 μg/l.
    • Bone disease progression defined by the appearance of ≥2 new
    lesions on a bone scan (confirmed by a second bone scan 6 weeks later).
    • Soft tissue disease progression defined by modified RECIST 1.1.
    - ECOG performance status 0-2
    - Written informed consent according to ICH-GCP
    - histologisch of cytologisch bevestigde diagnose adenocarcinoom van de
    prostaat zonder neuroendocriene differentiatie of kleincellige kenmerken
    - Voortdurende androgeendeprivatie door middel van LHRHagonisten/
    antagonisten of orchidectomie
    - Serum testosteron < <50 ng/ml (1.7 nmol/L) binnen 21 dagen
    voorafgaand aan studie-inclusie
    - Leeftijd 18 jaar of ouder
    - Ziekteprogressie tijdens of na behandeling met doxetaxel,
    gedefinieerd als 1 of meer van de volgende criteria
    o Minstens 3 opeenvolgende PSA stijgingen boven een
    referentiewaarde, met een interval van minstens 1 week tussen elke
    bepaling. PSA moet ≥ 2.0 μg/l ten tijde van screening
    o Ziekteprogressie van het skelet gedefinieerd als het verschijnen van 2
    of meer nieuwe lesies op een botscan (bevestigd met een tweede
    botscan na 6 weken)
    o Ziekteprogressie van de weke delen volgens gemodificeerde RECIST
    1.1 criteria
    - ECOG performance status 0-2
    - Schriftelijke geïnformeerde toestemming volgens ICH-GCP richtlijnen
    E.4Principal exclusion criteria
    • Geographical, psychological or other non-medical conditions
    interfering with follow-up
    • Uncontrolled severe illness or medical condition (including
    uncontrolled diabetes mellitus or active systemic or local bacterial, viral,
    fungal - or yeast infection)
    • Symptomatic CNS metastases or history of psychiatric disorder that
    would prohibit the understanding and giving of informed consent.
    • Chemotherapy or immunotherapy (other than LHRH analogues)
    within the last 4 weeks before study inclusion.
    • Prior treatment with cabazitaxel
    • Successive treatment with both abiraterone and enzalutamide in the
    post-docetaxel setting
    • Radiotherapy to 40% or more of the bone marrow
    • Known hypersensitivity to corticosteroids
    • History of severe hypersensitivity reaction (≥grade 3) to docetaxel
    • History of severe hypersensitivity reaction (≥grade 3) to polysorbate
    80 containing drugs
    • Concurrent or planned treatment with strong inhibitors or strong
    inducers of cytochrome P450 3A4/5 (a one week wash-out period is
    necessary for patients who are already on these treatments) (see
    Appendix C)
    • Concomitant vaccination with yellow fever vaccine
    • Abnormal liver functions consisting of any of the following (within 21
    XML File Identifier: Ox6Q0W5xu5l8id6EpdbT1nRYoE4=
    Page 11/21
    days before treatment group allocation):
    • Total bilirubin > 1.5 x ULN (except for patients with documented
    Gilbert's disease)
    • If total bilirubin > 1 x ULN or AST > 1.5 x ULN inclusion is permitted
    but cabazitaxel dose should be reduced 20mg/m2
    • Abnormal hematological blood counts consisting of any of the
    following (within 21 days before treatment group allocation):
    • Absolute neutrophil count < 1.5 x 109/L
    • Platelets < 100 x 109/L
    • Hemoglobin < 6.2 mmol/L
    - Geografische, psychologische of andere niet-medische aandoeningen
    die interfereren met follow-up
    - Ongecontroleerde ernstige ziekte (inclusief ongereguleerde diabetes
    mellitus of actieve systemische of lokale bacteriële, virale, gist- of
    schimmelinfectie)
    - Symptomatische hersenmetastasen of voorgeschiedenis van
    psychiatrische ziekte die het begrijpen en geven van toestemming
    belemmert
    - Chemotherapie of immuuntherapie (anders dan LHRH analogen)
    binnen 4 weken voor inclusie in de studie
    - Eerdere behandeling met cabazitaxel
    - Opeenvolgende behandeling met zowel abiraterone als enzalutamide
    na docetaxelbehandeling
    - Radiotherapie op 40% of meer van het beenmerg
    - Geschiedenis van ernstige overgevoeligheidsreactie (≥graad 3) op
    docetaxel
    - Geschiedenis van ernstige overgevoeligheidsreactie (≥graad 3) op
    polysorbaat 80-bevattende medicatie
    - Bekende overgevoeligheid voor corticosteroïden
    - Gelijktijdige of geplande behandeling met sterke remmers of
    stimulators van cytochroom P450 3A4/5 (patiënten die deze medicatie
    reeds gebruiken dienen een week van tevoren gestopt te zijn)
    - Gestoorde leverfunctie gedefinieerd als een van de onderstaande
    (bepaald binnen 21 dagen voor toewijzen behandelarm):
    o Totaal bilirubine >1.5x de bovengrens van de normaalwaarde
    (uitgezonderd patiënten met gedocumenteerde ziekte van Gilbert)
    o Totaal bilrubine >1x de bovengrens van normaal of aspartate
    aminotransferase (ASAT) > 1.5 x de bovengrens van de normaalwaarde
    is toegestaan maar cabazitaxel dosis dient gereduceerd te worden tot
    20mg/m2.
    - Gestoorde hematologische bloedwaardes gedefinieerd als een van de
    onderstaande (bepaald binnen 21 dagen voor toewijzen behandelarm):
    o Absoluut neutrofielengetal < 1.5 x 109/L
    o Trombocyten < 100 x 109/L
    o Hemoglobine < 6.2 mmol/L
    E.5 End points
    E.5.1Primary end point(s)
    PSA response rate, defined as the percentage of AR-V7 positive cabazitaxel-treated patients with a ≥50% PSA decline from baseline.
    Het primaire eindpunt is PSA respons, gedefinieerd als het percentage AR-V7 positieve patiënten die onder cabazitaxel behandeling een ≥50% PSA afname laten zien vanaf baseline
    E.5.1.1Timepoint(s) of evaluation of this end point
    12-15 weeks after start of treatment
    12-15 weken na start van de behandeling
    E.5.2Secondary end point(s)
    CTC response rate, progression-free survival and overall survival to cabazitaxel in AR-V7 positive patients, as well as toxicity and cumulative administered dose of cabazitaxel in second and third-line therapy. Furthermore, we want to explore the relationship between systemic cabazitaxel exposure and response
    Secundaire uitkomstmaten zijn onder andere CTC respons, progressievrije overleving en totale overleving op cabazitaxel in AR-V7 positieve patiënten en toxiciteit van en cumulatief toegediend dosis cabazitaxel in tweede vs. derdelijns behandeling. Ook wordt gekeken naar de relatie tussen systemische cabazitaxel blootstelling en respons.
    E.5.2.1Timepoint(s) of evaluation of this end point
    PFS, OS, toxicity and cumulative administered
    cabazitaxel dose: end of the study
    CTC response rate, relation between response and systemic cabazitaxel exposure: 12-15
    weeks after start of the study
    PFS, OS, toxiciteit en cumulatief toegediende dosis
    cabazitaxel: eind van de studie
    CTC respons, relatie tussen respons en systemische blootstelling aan cabazitaxel: 12-
    15 weken na start van behandeling
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    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 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 concerned10
    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 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 defined as the last patient's last visit.
    Het einde van de studie is gedefinieerd als het laatste bezoek van de
    laatste patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state100
    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)
    none
    geen
    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 Decision2016-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-26
    P. End of Trial
    P.End of Trial StatusOngoing
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