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    Summary
    EudraCT Number:2019-001083-30
    Sponsor's Protocol Code Number:VIGAS2
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-04-03
    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 ConcernedSweden - MPA
    A.2EudraCT number2019-001083-30
    A.3Full title of the trial
    A multicenter randomized double-blinded controlled
    phase 2 study evaluating the efficacy of valganciclovir as
    add-on therapy in glioblastoma patients
    En multicenter randomiserad dubbel-blind kontrollerad fas 2 studie som avser utvärdera effekten av valganciclovir hos glioblastom patienter
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to evaluate the effect of the anti-viral drug Valganciclovir in brain tumor patients
    En kliniska studie som avser utvärdera effekten av anti-virus läkemedlet valganciclovir hos hjärntumör patienter.
    A.4.1Sponsor's protocol code numberVIGAS2
    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 SponsorKarolinska Institutet
    B.1.3.4CountrySweden
    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 supportKarolinska Instituet
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKarolinska University Hospital; SLL
    B.5.2Functional name of contact pointKonstantinos Kostulas@sll.se
    B.5.3 Address:
    B.5.3.1Street AddressKarolinska Universitetssjukhuset Hotellet plan 4
    B.5.3.2Town/ citySolna
    B.5.3.3Post code17176
    B.5.3.4CountrySweden
    B.5.4Telephone number+4672595 7237
    B.5.6E-mailkonstantinos.kostulas@sll.se
    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 Information not present in EudraCT
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 namevalganciclovir
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Glioblastoma is an incurable brain tumor with very dismal prognosis. Substantial evidence demonstrates that cytomegalovirus (CMV) is present in 90-100% of malignant glioblastoma.We have observed that valganciclovir is well tolerated among glioblastoma patients receiving temozolomide and radiation therapy. We further observed that treatment with valganciclovir may enhance the survival chances for glioblastoma patients. We aim to assess the efficacy of Valganciclovir in glioblastoma patients.
    Glioblastom är en obotlig hjärntumör med mycket dyster prognos. Bevis talar för att cytomegalovirus (CMV) är närvarande i 90-100% malignt glioblastom. Vi har observerat att valganciklovir tolereras väl bland glioblastompatienter som får temozolomid och strålbehandling. Vi observerade vidare att behandling med valganciklovir tycks kunna öka överlevnadschanserna för patienter med glioblastom. Vi strävar efter att utvärdera effekten av Valganciclovir hos patienter med glioblastom.
    E.1.1.1Medical condition in easily understood language
    Brain tumor glioblastoma
    Hjärntumören glioblastom
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    To assess the efficacy of Valganciclovir in glioblastoma patients.
    Utvärdera effekten av Valganciclovir hos glioblastoma patienter.
    E.2.2Secondary objectives of the trial
    Evaluate tumor volume, proportion of patients with stable / progressive disease, quality of life, safety aspects and subgroup analyzes regarding CMV status.
    Utvärdera tumörvolym, andel patienter med stabil/progressiv sjukdom, livskvalitet, säkerhetsaspekter och subgruppsanalyser map CMV status.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients aged 18 years or older
    2. Patients with newly diagnosed glioblastoma, IDH 1 wt, WHO grade IV
    3. Radical resection; no more than 1 cm3 remaining contrast enhancement tumor by MRI or CT, postoperatively.
    4. Concomitant treatment with temozolomide and radiation therapy
    5. MGMT promoter methylation status
    6. Patients with at least KPS 70 , ECOG/WHO 2
    7. Patients providing written informed consent
    8. Patients cooperative and able to complete all the assessment procedures.
    9. Patient agrees to utilize two reliable methods of contraception combined throughout the study period.
    10. Females of childbearing age potential must have a negative pregnancy test at screening.
    11. Patients must be enrolled within 6 weeks after surgery
    1. Patienter 18 år eller äldre
    2. Patienter med nyligen diagnostiserad glioblastom, IDH 1 vildtyp, WHO klass IV
    3. Radikal resektion 1 cm3 kvarvarande kontrastförstärkningstumör vid MR eller CT, postoperativt.
    4. Samtidig behandling med temozolomid och strålbehandling
    5. MGMT-promotorns metyleringsstatus
    6. Patienter med minst KPS 70, ECOG / WHO 2
    7. Patienter som lämnar skriftligt informerat samtycke
    8. Patienterna samarbetar och kan slutföra alla bedömningsförfaranden.
    9. Patienten samtycker till att använda två tillförlitliga preventivmedel kombinerade under hela studietiden.
    10. Kvinnor i fertil ålderspotential måste ha ett negativt graviditetstest vid screening.
    11. Patienterna måste vara inskrivna inom 6 veckor efter operationen
    E.4Principal exclusion criteria
    1. Patients allergic to, or who do not tolerate Valganciclovir, aciclovir or valaciclovir treatment
    2. Patients with decreased cognitive function (below 24 in MMSE test)
    3. Pregnant or lactating females
    4. Patients not signing informed consent
    5. Patient is simultaneously participating in another experimental drug therapy trial
    6. Neutrophil count < 1500 cells/mm3l
    7. Platelet count < 150 000 cells/ mm3
    8. HGB < 8g/dL
    9. Abnormal renal function (GFR < 30)
    10. Secondary glioblastoma, or glioblastoma IDH1 mutated.
    11. Unfit for any other reason judged by investigator
    1. Patienter som är allergiska mot eller som inte tolererar behandling med valganciklovir, aciklovir eller valaciklovir
    2. Patienter med nedsatt kognitiv funktion (under 24 i MMSE-test)
    3. Gravida eller ammande kvinnor
    4. Patienter som inte undertecknar informerat samtycke
    5. Patienten deltar samtidigt i en annan experimentell läkemedelsbehandling
    6. Neutrofilantal <1500 celler / mm3l
    7. Antalet blodplättar <150 000 celler / mm3
    8. HGB <8 g / dL
    9. Onormal njurfunktion (GFR <30)
    10. Sekundärt glioblastom, eller glioblastom IDH1 muterat.
    11. Olämplig av någon annan anledning bedömd av utredaren
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint point: Median overall survival at 30 months follow up time.
    Primär utfallsanalys: Medianöverlevnad vid 30 månaders uppföljningstid.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 months follow up time after inclusion.
    30 månaders uppföljningstid efter inklusion.
    E.5.2Secondary end point(s)
    • Proportion of patients alive at 12 and 24 months
    • Overall progression free survival (RANO and NANO criteria)
    • Quality of life assessments (EORTC QoL questionnaire at base line and every three months at routine checkups (3, 6, 9, 12, 15 18, 21, 24 and 30 months)
    • Patient overall survival and median survival time (patients are followed until death).
    • Proportion of patients with progressive disease at 24 months (RANO criteria).
    • Proportion of patients with progressive disease at 24 months (Clinical and NANO criteria).
    • Proportion of patients with stable disease at 12 and 24 months (RANO criteria).
    • Proportion of patients with recurrence at 12 and 24 months
    • Continuous proportion of progressive disease
    • Continuous proportion of stable disease
    • Continuous proportion of patients with treatment failure
    • Subgroup analyses will be performed on CMV positive patients.
    • Safety assessements
    • Andelen patienter som lever vid 12 och 24 månader
    • Övergripande progressionsfri överlevnad (RANO och NANO kriterier)
    • Livskvalitetsbedömningar (EORTC QoL-frågeformulär vid baslinjen och var tredje månad vid rutinmässiga kontroller (3, 6, 9, 12, 15, 18, 21, 24 och 30 månader)
    • Övergripande överlevnad och överlevnadstid för patienten (patienter följs till döden).
    • Andel patienter med progressiv sjukdom efter 24 månader (RANO-kriterier).
    • Andel patienter med progressiv sjukdom efter 24 månader (kliniska och NANO-kriterier).
    • Andel patienter med stabil sjukdom vid 12 och 24 månader (RANO kriterier).
    • Andel patienter med återfall vid 12 och 24 månader
    • Kontinuerlig andel av progressiv sjukdom
    • Kontinuerlig andel av stabil sjukdom
    • Kontinuerlig andel patienter med behandlingssvikt
    • Undergruppsanalyser kommer att utföras på CMV-positiva patienter.
    • Säkerhetsbedömningar
    E.5.2.1Timepoint(s) of evaluation of this end point
    Tumor volume/ disease status assessments at 12 and 24 months, Quality of life assessments at:3, 6, 9, 12, 15, 18, 21, 24 och 30 months.
    Tumörvolym / sjukdomsaktivitetsbedömningar vid 12 och 24 månader, Livskvalitetsbedömningar vid: 3, 6, 9, 12, 15, 18, 21, 24 och 30 månader.
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Israel
    United States
    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
    30 months follow up evaluates primary and secondary end point analyses. Glioblastoma is a severe diagnosis and patients are followed for life by their respective clinic for patient care.
    30 månaders uppföljning utvärderar primära och sekundära utfallsanalyser. Glioblastom är en allvarlig diagnos och alla patienter följs upp hela livet vid sin respektive klinik för patientvård.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 220
    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)
    Glioblastoma is a severe diagnosis and patients are followed for life by their respective clinic for patient care.
    Glioblastom är en allvarlig diagnos och patienter följs upp hela livet genom sin respektive klinik för patientvård.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-26
    P. End of Trial
    P.End of Trial StatusOngoing
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