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    Summary
    EudraCT Number:2014-002439-32
    Sponsor's Protocol Code Number:SirTac2014
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-02-13
    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 ConcernedGermany - BfArM
    A.2EudraCT number2014-002439-32
    A.3Full title of the trial
    A Randomized Phase II Trial of Transarterial Radioembolization with Yttrium-90 (SIRT) in Comparison to Transarterial Chemoembolization with Cisplatin (TACE) in Patients with Liver Metastases from Uveal Melanoma
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized Phase II Trial of SIRT and TACE in Liver Metastases of Uveal Melanoma
    A.3.2Name or abbreviated title of the trial where available
    SirTac
    A.4.1Sponsor's protocol code numberSirTac2014
    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 SponsorCharité – Universitätsmedizin Berlin
    B.1.3.4CountryGermany
    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 supportSirtex Medical Inc
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportPharmaCept GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité - Universitätsmedizin Berlin
    B.5.2Functional name of contact pointCharité Comprehensive Cancer Center
    B.5.3 Address:
    B.5.3.1Street AddressCharitéplatz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10117
    B.5.3.4CountryGermany
    B.5.4Telephone number004930450 564 222
    B.5.5Fax number004930450 564 999
    B.5.6E-mailulrich.keilholz@charite.de
    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 Cisplatin Neo Corp® 1 mg/ml - Konzentrat zur Herstellung einer Infusionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderHexal AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 nameCisplatin
    D.3.2Product code 39021.01.00
    D.3.4Pharmaceutical form Solution for injection/infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCisplatin Neo Corp® 1 mg/ml
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.3Concentration number0,5
    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) Yes
    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) Yes
    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
    Liver Metastases from Uveal Melanoma
    E.1.1.1Medical condition in easily understood language
    Liver Metastases from Uveal Melanoma
    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
    This is a randomized phase II trial to evaluate the relative efficacy of transarterial radioembolization with yttrium-90 microspheres (SIRT) in comparison to standard treatment with transarterial chemoembolization with cisplatin (DSM-TACE) in patients with liver metastases due to advanced uveal melanoma in terms of progression-free survival.
    E.2.2Secondary objectives of the trial
    To compare quality of life during treatment and feasibility of the two treatment options.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female patients ≥ 18 years of age
    • ECOG PS of 0, 1 or 2
    • Histologically or cytologically confirmed liver metastases of uveal melanoma
    • At least one measurable lesion according to RECIST criteria v1.1 determined MRI (if contraindications against MRI exist CT with contrast media can is allowed)
    • Metastases in other sides are allowed if not in need of treatment (e.g. asymptomatic bone metastasis without indication for radiation)
    • Life expectancy > 3 months
    • Signed informed consent
    • The following laboratory parameters must be met at time of inclusion:
    o Total bilirubin < 3x ULN
    o Neutrophil granulocytes ≥ 1.0/nl
    o Leucocytes ≥ 2.5/nl
    o Platelets ≥ 100/nl
    o Haemoglobin ≥ 9 g/dl
    o Serum creatinine < 1.5 mg/dl
    o aPTT ≤ 50 sec.
    o Prothrombine time (PT) ≥ 70%
    o Serum albumine ≥ 28 g/l
    o SGOT, SGPT < 2x ULN
    • Prior treatment with systemic anti-cancer therapy is allowed if terminated ≥ 4 weeks prior to study treatment start and recovery from toxicity is achieved
    • Surgery in general and hepatic surgery in particular (e.g. lobe resection, radiofrequency ablation) prior to study enrollment are allowed if realized ≥ 4 weeks prior to study enrollment and recovery from surgery is achieved
    • Women of childbearing potential must have a negative serum pregnancy test within 7 days of the first administration of study treatment and must be willing to use adequate methods of contraception (pearl index < 1) during the study and for 3 months after last study drug administration
    E.4Principal exclusion criteria
    Surgically treatable liver metastases
    Previous intraarterial hepatic treatment (e.g. radioemolization, chemoembolization, intraarterial chemotherapy, isolated or percutaneous hepatic perfusion)
    Previous treatment with external liver radiation
    Major intrahepatic occlusion of the portal vein and/or tumor infiltration of the portal vein
    Liver cirrhosis Child-Pugh C
    Other malignancy and/or metastases in need of treatment
    Current treatment with any anti-cancer therapy
    One of the following existing medical conditions:
    o Unstable cardiac disease despite treatment, congestive heart failure NYHA grade > II, malignant cardiac arrhythmia
    o Significant neurologic or psychiatric disorders including dementia
    o Active uncontrolled infection
    o Active disseminated intravascular coagulation
    o Active bleeding diathesis or patients on oral anti-vitamin-K medication or comparable coagulation influencing medication (such as thrombin inhibitors as dabigatran or direct Factor Xa inhibitors as rivaroxaban or apixaban)
    o Known history of HIV seropositivity or Hepatitis B or C infection
    o Any other severe and/or uncontrolled medical conditions which could impair the ability of the patient to participate in the study
    • Pregnancy (absence confirmed by serum ß-HCG test) or breast-feeding
    • Known allergic reactions or hypersensitivity to any of the components of the treatment
    • Legal incapacity or limited legal capacity or existing medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or to sign meaningful informed consent
    • Accommodation in an institution under officially or judicially orders (§40 p.1 No. 4 AMG)
    • Participation in an interventional study in the last 30 days before inclusion in this trial
    • Employees of the study site are excluded from participation in the trial (§40 subparagraph 1 No. 3b AMG)
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 6 weeks.
    E.5.2Secondary end point(s)
    • Hepatic response (CR + PR)
    • Toxicity
    • Disease control (PR + CR + SD)
    • Hepatic progression-free survival (PFS-L)
    • Overall survival (OS)
    • Quality of Life (QoL)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Interrim analysis after 20 patients have been accrued to each study arm and final analysis after inclusion of 45 patients in each study arm (total of 90 patients).
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial2
    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
    End of trial is defined as the last follow-up visit of the last patient. The follow-up phase is 12 months.
    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: 90
    F.1.3Elderly (>=65 years) No
    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 state90
    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)
    Post-treatment follow-up will be conducted every 6 weeks for general state of health and course of disease.
    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 Decision2015-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-22
    P. End of Trial
    P.End of Trial StatusOngoing
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