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    Summary
    EudraCT Number:2019-003857-27
    Sponsor's Protocol Code Number:LUPSA
    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:2019-12-09
    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 number2019-003857-27
    A.3Full title of the trial
    177Lu-PSMA Radioligand Therapy for advanced salivary gland cancer, a phase II pilot study.
    177Lu-PSMA radioligand therapie voor gevorderde speekselklierkanker, een fase II pilot study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Radioactive labeled PSMA therapy for advanced salivary gland cancer
    Radioactief gelabeld PSMA therapie voor gevorderde speekselkleirkanker.
    A.3.2Name or abbreviated title of the trial where available
    LUPSA
    A.4.1Sponsor's protocol code numberLUPSA
    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 SponsorRadboudumc
    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 supportKWF dutch cancer society
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRadboud university medical center
    B.5.2Functional name of contact pointDepartment of Medical Oncology
    B.5.3 Address:
    B.5.3.1Street AddressGeert Grooteplein Zuid 8
    B.5.3.2Town/ cityNijmegen
    B.5.3.3Post code6525 GA
    B.5.3.4CountryNetherlands
    B.5.6E-mailMaike.JM.Uijen@radboudumc.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 nameLutetium-177-PSMA-I&T
    D.3.2Product code Lutetium-177-PSMA-I&T
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPSMA I&T
    D.3.9.3Other descriptive namePSMA I&T
    D.3.9.4EV Substance CodeSUB199344
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 Yes
    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
    Salivary gland cancer.
    More specifically two subtypes: adenoid cystic carcinoma and salivary duct carcinoma.
    Speekselklierkanker.
    Meer specifiek twee subtypen: adenoid cysteus carcinoom en salivary duct carcinoom.
    E.1.1.1Medical condition in easily understood language
    Two subtypes of salivary gland cancer
    Twee vormen van speekselklierkanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    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 safety and efficacy of lutetium-177-PSMA radioligand therapy in patients with advanced adenoid cystic carcinoma or salivary duct carcinoma with PSMA ligand uptake.
    Het evalueren van de veiligheid en werkzaamheid van lutetium-177-PSMA radioligand therapie bij patiënten met gevorderde adenoid cysteus carcinoom en salivary duct carcinoom.
    E.2.2Secondary objectives of the trial
    - Assess the progression free survival (PFS).
    - Assess the overall survival (OS).
    - Assess the duration of response (DoR).
    - To calculate the dose delivered by 177Lu-PSMA RLT.
    - To determine the radiation toxicity (focusing on radiation doses to organs at risk) of 177Lu-PSMA RLT.
    - Assess the QoL of patients treated with 177Lu-PSMA RLT using EORTC questionnaires.
    - To explore differences in tumor mutational burden, immunohistochemical expression profiles and intracellular pathways between responding and non-responding patients.
    - progressie vrije overleving vaststellen
    - algehele overleving vaststellen
    - duur van de respons vaststellen
    - het berekenen van de dosis
    - het bepalen van de stralingstoxiciteit (gericht op organen die blootgesteld worden aan de straling van 177Lu-PSMA radioligand therapie)
    - het meten van de kwaliteit van leven van de behandelde patiënten, door middel van gevalideerde vragenlijsten
    - exploreren van verschillen in tumor mutaties, immunuhistochemie en intracellulaire eigenschappen tussen patiënten die reageren vergeleken met patiënten die niet reageren
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients must have the ability to provide written informed consent.
    - Patients must be ≥ 18 years of age.
    - Patients must have an ECOG performance status of 0 to 2.
    - Patients must have histological, pathological, and/or cytological confirmation of either adenoid cystic carcinoma or salivary duct carcinoma.
    - Patients must have incurable, local or regional recurrent or metastatic ACC or SDC.
    - Patients with ACC can only participate in case of objective growth in the last three months or complaints due to the disease.
    - Patients must have adequate organ function:
    Sufficient bone marrow capacity as defined by: WBC count (white blood cell) ≥2.5x10^9/L, PLT (platelet) count ≥100x10^9/L, Hb ≥6 mmol/L, absolute neutrophil count (ANC) ≥1.5x10^9/L
    Adequate liver function as defined by: Total bilirubin ≤1.5 x ULN. For patients known with Gilbert’s Syndrome ≤ 3 x ULN is permitted. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN OR ≤5.0 × ULN for patients with liver metastases.
    Adequate kidney function as defined by: Serum creatinine ≤1.5 x ULN or creatinine clearance ≥ 50 mL/min
    - Patients must have measurable disease at baseline. Defined as ≥ 1 lesion ≥ 2 cm (long axis) that is present on baseline CT.
    - Patients must have a positive 68Ga-PSMA PET/CT scan, defined by at least one lesion ≥ 1.5 cm (long axis) with a ligand uptake above liver level.
    - patiënten moeten in staat zijn om informed consent te kunnen geven.
    - patiënten moeten ≥ 18 jaar zijn.
    - patiënten moeten een ECOG performance status hebben van 0 tot 2
    - patiënten moeten histologisch, pathologisch en/of cytologisch bewezen adenoid cysteus carcinoom of salivary duct carcinoom hebben.
    - alleen patiënten met lokaal uitgebreid, teruggekomen of uitgezaaid adenoid cysteus carcinoom of salivary duct carcinoom kunnen deelnemen.
    - patiënten met een adenoid cysteus carcinoom kunnen alleen deelnemen indien er objectieve groei is de laatste 3 maanden of indien patiënten klachten heeft gerelateerd aan de ziekte.
    - patiënten moeten een adequate orgaan functie hebben:
    voor het beenmerg is dit gedefinieerd als: leukocyten ≥2.5x10^9/, trombocyten ≥100x10^9/L, Hb ≥6 mmol/L en abcolute neutrofielen ≥1.5x10^9/L
    voor de lever is dit gedefinieerd als: totaal bilirubine ≤1.5 x ULN. Voor patiënten bekend met Gilbert’s Syndrome ≤ 3 x ULN is toegestaan. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 × ULN OR ≤5.0 × ULN voor patiënten die bekend zijn met levermetastasen.
    voor de nieren is dit gedefinieerd als: serum creatinine ≤1.5 x ULN or creatinine clearance ≥ 50 mL/min
    - patiënten moeten een meetbare ziekte hebben. Dit is gedefinieerd als ≥ 1 lesie ≥ 2 cm (lange as) die aanwezig is op de baseline CT.
    - patiënten moeten een positieve 68Ga-PSMA PET/CT scan hebben, gedefinieerd als ten minste een laesie van 1.5 cm (lange as) met ligand opname boven de leveropname.
    E.4Principal exclusion criteria
    - Patients whom are pregnant or breast feeding.
    - Patients with reproductive potential not implementing adequate contraceptives measures.
    - Patients with known brain metastases or cranial epidural disease or intracardial metastases.
    - Patients with concurrent serious (as determined by the Principal Investigator) medical conditions, including, but not limited to, New York Heart Association class III or IV congestive heart failure, history of congenital prolonged QT syndrome, uncontrolled infection, active hepatitis B or C, or other significant comorbid conditions that in the opinion of the investigator would impair study participation or cooperation.
    - Patients with urinary tract obstruction or marked hydronephrosis
    - Less than 4 weeks since last myelosuppressive therapy or other radionuclide therapy.
    - Concomitant cancer treatments
    - Patiënten die zwanger zijn of borstvoeding geven
    - Patiënten in de vruchtbare levensfase en die geen adequate anticonceptie gebruiken
    - Patiënten die bekend zijn met hersenmetastasen of craniele epidurale ziekte of intracardiale metastasen
    - Patiënten met gelijktijdige ernstige medische aandoeningen (bepaald door de hoofdonderzoeker), waaronder niet beperkt tot: New York Heart Association klasse III of IV hartfalen, geschiedenis van aangeboren verlengd QT syndroom, ongecontroleerde infectie, actieve hepatitis B of C, andere significante comorbiditeit die naar mening van de onderzoeker niet wenselijk zijn voor deelname aan de studie.
    - Patiënten met een urineweginfectie of hydronefrose
    - Minder dan 4 weken sinds laatste beenmergonderdrukkende therapie of andere radionuclide therapie
    - Gelijktijdige kankerbehandeling
    E.5 End points
    E.5.1Primary end point(s)
    Safety: Safety and tolerability will be studied by analysis of adverse events, physical examinations, vital signs, Eastern Cooperative Oncology Group (ECOG) per-formance status, and laboratory-abnormality assessments. Severity of adverse events will be rated by investigators by use of the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0
    Veiligheid: Veiligheid en verdraagbaarheid zullen worden bestudeerd door analyse van bijwerkingen, lichamelijk onderzoek, vitale functies, prestatiestatus van de Eastern Cooperative Oncology Group (ECOG) en beoordelingen van laboratoriumafwijkingen. De ernst van bijwerkingen wordt door onderzoekers beoordeeld aan de hand van de National Terminology Criteria for Adverse Events (CTCAE) v5.0 van het National Cancer Institute
    E.5.1.1Timepoint(s) of evaluation of this end point
    During study and at 6 monhts, 12 months and 3 years after start of study.
    Gedurende de studie en op 6 maanden, 12 maanden en 3 jaar na de start van de studie.
    E.5.2Secondary end point(s)
    - Efficacy: by objective response rate (ORR)
    - Progression free survival (PFS)
    - Overal survival (OS)
    - Duration of response (DoR)
    - Quality of life (QoL)
    - delivered dose
    - radiation toxicity
    - to explore differences in tumor mutational burden, immunohistochemical expression profiles and intracellular pathways between responding and non-responding patients
    - effectiviteit: middels de ojbjectief responspercentage
    - progressie vrije overleving
    - algemene overleving
    - duur van respons
    - kwaliteit van leven
    - geleverde dosis
    - stralingstoxiciteit
    - verschil in tumoreigenschappen exploreren tussen patiënten die wel en niet reageren op de behandeling
    E.5.2.1Timepoint(s) of evaluation of this end point
    During study and at 6 monhts, 12 months and 3 years after start of study.
    Gedurende de studie en op 6 maanden, 12 maanden en 3 jaar na de start 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 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 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
    LVLS
    laatste bezoek van laatste patiënt
    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 months6
    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: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 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)
    resume normale care
    hervatten van reguliere zorg
    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 Decision2019-12-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-23
    P. End of Trial
    P.End of Trial StatusOngoing
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