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    Summary
    EudraCT Number:2020-003474-45
    Sponsor's Protocol Code Number:74742
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-11-17
    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 number2020-003474-45
    A.3Full title of the trial
    The STELLAR trial: Fluorescence-guided surgery in laryngeal- and hypopharyngeal cancer: a feasibility trial
    de STELLAR studie: fluorescentie geleide chirurgie bij strottenhoofd kanker: een haalbaarheid studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The STELLAR Trial
    De STELLAR studie
    A.3.2Name or abbreviated title of the trial where available
    Fluorescence-guided surgery in laryngeal- and hypopharyngeal cancer: a feasibility trial
    fluorescentie geleide chirurgie bij strottenhoofd kanker: een haalbaarheid studie
    A.4.1Sponsor's protocol code number74742
    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 University Medical Center
    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 kanker bestrijding
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus University Medical Center
    B.5.2Functional name of contact pointTrial information
    B.5.3 Address:
    B.5.3.1Street AddressDr. Molewaterplein 40
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015 GD
    B.5.3.4CountryNetherlands
    B.5.6E-mails.keereweer@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 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 namecRGD-ZW800-1
    D.3.2Product code IGS Peptide 1
    D.3.4Pharmaceutical form Lyophilisate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Intravenous bolus use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNcRGD-ZW800-1
    D.3.9.3Other descriptive namecRGD-ZW800-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.725
    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
    Squamous cell carcinoma of the larynx and hypoharynx
    plaveiselcelcarcinoom van het strottenhoofd
    E.1.1.1Medical condition in easily understood language
    Cancer of the larynx and hypopharynx
    kanker van het strottenhoofd
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
    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
    The primary aim of this study is to determine the feasibility of using intraoperative fluorescence-imaging (FLI) to identify laryngealand hypopharyngeal
    cancer during total laryng(opharyng-)ectomy. A tumor-to-Background ratio (TBR) of >2.0 is defined as 'feasible'.
    Het hoofddoel van deze studie is om de bruikbaarheid te testen van intraoperatieve fluorescentie om tumoren van het strottenhoofdte identificeren tijdens een totale laryng-(opharyng)ectomie. Een tumor-achtergrond ratio van >2.0 wordt geacht als 'bruikbaar'.
    E.2.2Secondary objectives of the trial
    - The rate of clear resection margins with FLI
    - Sensitivity, specificity, positive and negative predictive values of FLI;
    - The percentage of intra-operative change in surgical management bases on FLI (i.e. percentage of extra resection)
    - The time needed for fluorescence imaging;
    - FLI of excised lymph nodes (in vivo and ex vivo);
    - Influence of previous radiotherapy on the FLI performance;
    - Adverse events and toxicity of cRGD-ZW800-1;
    - Percentage van vrije resectie vlakken.
    - Sensitiviteit, specificiteit en positieve voorspelwaardes van fluorescentie geleide chirurgie bij larynx en/of hypopharynx tumoren
    - Het percentage extra weefsel resecties gebaseerd op fluorescentie beeldvorming gestuurde vriescoupes
    - De benodigde tijd voor fluorescentie beeldvorming
    - Het percentage van lymfeklieren die zichtbaar zijn met fluorescentie beeldvorming
    - De invloed van eerdere radiotherapie op de kwaltieit van het fluorescente signaal
    - De bijwerkingen en toxiciteit van cRGD-ZW800-1
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with biopsy-proven squamous cell LHC, eligible for surgical resection of the tumor by TL(P);
    - ≥ 18 years of age;
    - Written informed consent must be obtained;
    - Sufficient knowledge of the Dutch language to understand the informed consent form;
    - Patienten met biopt-bevestigd plaveiselcarcinoom van de larynx, die in aanmerking komen voor chirurgischeresectie van de primaire tumor door middel van een totale laryng(opharyng-)ectomie;
    - Patient ≥ 18 jaar oud;
    - Schriftelijke 'informed consent' moet worden verkregen;
    - Voldoende kennis van de Nederlandse taal om het informed consent formulier te begrijpen;
    E.4Principal exclusion criteria
    - History of a clinically significant allergy or anaphylactic reactions to any of the components of the agent;
    - Other synchronous biopsy proven malignancies currently active, except for adequately treated in situ carcinomaof cervix and basal or squamous cell skin carcinoma;
    - Patients pregnant or breastfeeding, lack of effective contraception in male or female patients with reproductivepotential;
    - Patients with renal insufficiency (defined as eGFR<60);
    - Patients with previous kidney transplantation or a solitary functioning kidney
    - Immuno-compromised patients who do not have the ability to respond normally to an infection due to an impairedor weakened immune system, caused by either a pre-existing disease or concomitant medications;
    - Patients using medications that may significantly impair renal function (i.e. NSAIDs, particularly COX-2inhibitors), that cannot be paused during the course of the study;
    - Patients with ASA classification of 4 or higher;
    - Patients with measured QTc of 500 ms or higher at screening;
    - Patients with laboratory abnormalities defined as:
    o Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase) or AlkalinePhosphatase levels above 5 times the ULN or;
    o Total bilirubin above 3 times the ULN or;
    o Platelet count below 100 x 109/L or;
    o Hemoglobin below 4 mmol/L (females) or below 5 mmol/l (males).
    - Patients who are scheduled to undergo surgery with the use of a stapler for closure.
    - Incapacitated subjects
    - Geschiedenis van een klinisch significante allergie of anafylactische reacties op een van de componenten vanhet middel.
    - Andere synchrone biopt bewezen malginiteiten ten tijde van studie, met uitzondering van adequaatbehandelende cervix carcinoma in situ of basaalcelcarcinoom van de huid
    - Patiënten die zwanger zijn of borstvoeding geven, gebrek aan effectieve anticonceptie bij mannelijke ofvrouwelijke patiënten met reproductief potentieel;
    - Patienten met nierfunctiestoornissen (eGFR<60)
    - Patienten met een nierstransplantatie in de voorgeschiedenis of een mono-nier
    - Patienten die immuungecompromiteerd zijn, door medicatie danwel door een ziekte/aandoening
    - Patienten die medicatie gebruiken die de nierfunctie kan aantasten (NSAIDs, in het bijzonder COX-2 remmers)die niet gestopt kunnen worden tijdens de studie
    - Patienten met ASA klasse 4 of hoger
    - Patienten met een QTc tijd van 500 ms of hoger tijdens screening
    - Patienten met de volgende labafwijkingen:
    - Patienten labafwijkingen gedefinieerd als:
    o Aspartate AminoTransferase, Alanine AminoTransferase, Gamma Glutamyl Transferase of AlkalinePhosphatase boven 5 keer normaalwaarde of;
    o Totaal bilirubine boven 3 keer normaalwaarde of;
    o Trombocyten onder 100 x 109/L of;
    o Hemoglobin onder 4 mmol/L (vrouwen) or onder 5 mmol/l (mannen).
    - Patienten waarbij het gepland is dat tijdens de operatie zal worden gesloten met een stapler.
    - Wilsonbekwame patiënten
    E.5 End points
    E.5.1Primary end point(s)
    - The intraoperative tumor-to-background ratio (TBR) of cRGD-ZW800-1 in patients with laryngeal and hypopharyngeal cancer
    - De intraoperatieve tumor-achtergrond ratio van CRGD-ZW800-1 in patienten met strottenhoofd kanker
    E.5.1.1Timepoint(s) of evaluation of this end point
    During surgery and follow up
    Tijdens de operatie en bij follow up
    E.5.2Secondary end point(s)
    - The rate of clear resection margins with FLI
    - Sensitivity, specificity, positive and negative predictive values of FLI;
    - The percentage of intra-operative change in surgical management bases on FLI (i.e. percentage of extra resection)
    - The time needed for fluorescence imaging;
    - FLI of excised lymph nodes (in vivo and ex vivo);
    - Influence of previous radiotherapy on the FLI performance;
    - Adverse events and toxicity of cRGD-ZW800-1;
    - Percentage van vrije resectie vlakken.
    - Sensitiviteit, specificiteit en positieve voorspelwaardes van fluorescentie geleide chirurgie bij larynx en/of hypopharynx tumoren
    - Het percentage extra weefsel resecties gebaseerd op fluorescentie beeldvorming gestuurde vriescoupes
    - De benodigde tijd voor fluorescentie beeldvorming
    - Het percentage van lymfeklieren die zichtbaar zijn met fluorescentie beeldvorming
    - De invloed van eerdere radiotherapie op de kwaltieit van het fluorescente signaal
    - De bijwerkingen en toxiciteit van cRGD-ZW800-1
    E.5.2.1Timepoint(s) of evaluation of this end point
    Until 2 weeks after discharge
    Tot 2 weken na ontslag
    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 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 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
    LVLS
    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 months0
    E.8.9.1In the Member State concerned 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: 26
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 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 state26
    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
    None
    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 Decision2021-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-02-17
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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