Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43876   clinical trials with a EudraCT protocol, of which   7294   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-001257-31
    Sponsor's Protocol Code Number:TACTIDA
    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:2021-07-02
    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 number2021-001257-31
    A.3Full title of the trial
    An open, single center two-step trial (A+B), comparing the safety and tolerability of idarubicin 10 mg and 15 mg after separate single hepatic intra-arterial injections of a drug formulation based on lipiodol emulsion in patients with unilobular or bilobular intermediate stage hepatocellular carcinoma.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A single center study comparing the safety and tolerability after separate single intra-hepatic (liver) injections of idarubicin 10 mg and 15 mg together with a lipid based formulation to patients with liver cancer.
    A.4.1Sponsor's protocol code numberTACTIDA
    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 SponsorDepartment of Pharmaceutical Biosciences, Uppsala University
    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 supportCancerfonden
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Pharmaceutical Biosciences, Uppsala University
    B.5.2Functional name of contact pointProfessor
    B.5.3 Address:
    B.5.3.1Street AddressBox 591
    B.5.3.2Town/ cityUppsala
    B.5.3.3Post code75124
    B.5.3.4CountrySweden
    B.5.6E-mailhans.lennernas@farmbio.uu.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 Yes
    D.2.1.1.1Trade name Zavedos®
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer AB
    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 nameidarubicin hydrochloride
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntrahepatic use (Noncurrent)
    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
    intermediate stage hepatocellular carcinoma
    E.1.1.1Medical condition in easily understood language
    primary liver cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10019828
    E.1.2Term Hepatocellular carcinoma non-resectable
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Study part A: To evaluate and compare the plasma pharmacokinetics of idarubicin and its active metabolite idarubicinol after two different doses of idarubicin administered with TACE in patients with hepatocellular carcinoma.

    Study part B: To evaluate long-term safety and population pharmacokinetics of idarubicin and idarubicinol in hepatocellular carcinoma patients treated with TACE.
    E.2.2Secondary objectives of the trial
    • To evaluate tumour-uptake and lymphatic uptake of lipiodol with computer tomography (CT).
    • To evaluate the anti-tumour effect defined as changes in tumour volume, the amount of necrosis using positron emission tomography (PET) and magnetic resonance imaging (MRI), histopathology, liver biopsies from tumour and nontumor tissues, and multi-omics techniques.
    • To compare the anti-tumour effect (amount of necrosis) achieved in vivo and in vitro in the same tumours.
    • To evaluate cardiotoxicity, hematologic, liver safety and other adverse events (with established biomarkers).
    • To evaluate and compare the plasma pharmacokinetics of IDA and IDAol between the different single local doses of IDA-emulsion and to assess interindividual variability (IIV) and inter-occasion variability (IOV) as well as covariate relationships and to characterize the relationship between the PK and the hematological, cardio and liver toxicity.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female adults (≥18 years),
    2. Diagnosis of HCC: based on the Guidelines issued by AASLD (American Association for the Study of Liver Diseases)
    3. HCC for which transplantation, surgical resection or percutaneous ablation are not indicated.
    4. Child-Pugh ≤ 7 p
    5. Performance status: ECOG 0-2 (WHO),
    6. Life expectancy of at least 3 months in absence of treatments
    7. Has been vaccinated against Covid-19 or has a negative PCR-test.
    8. Signature of informed consent obtained from the patient.
    E.4Principal exclusion criteria
    1. Portal vein thrombosis, with the exception of thrombosis of a segment branch of the portal vein,
    2. Extra hepatic cancer involvement,
    3. Contraindications to arteriography,
    4. Use of IDA and/or other anthracyclines for the last three months prior to inclusion into the study,
    5. Previous or ongoing transarterial chemoembolization (TACE) treatment,
    6. Known or suspect hypersensitivity to the investigational drug or to the investigational pharmacological class,
    7. Presence of localized or systemic infections (with the exception of HIV infection responsive to therapy, HBV and HCV),
    8. The patients must not be pregnant or attempt to get pregnant during the course of the study. Female patients of reproductive age must submit to a pregnancy test once monthly during the study and protect themselves from getting pregnant using a birth control method that can achieve a failure rate of less than 1% per year when used consistently and correctly (“Recommendations related to contraception and pregnancy testing in clinical trials”, supplied from www.hma.eu/
    9. Patients who are not capable of complying with the procedures established by the protocol and of signing the informed consent. In case of incapacitated patients unable to release their informed consent to take part in the study, the consent must be released and signed also by the parents/guardian or by the legal representative. Incapacitated patients must as well sign the informed consent to the best of their ability.
    10. Patients evaluated for a liver transplantation.
    E.5 End points
    E.5.1Primary end point(s)
    Study part A:
    • To compare the plasma AUC(0-t) for idarubicin and idarubicinol between the two doses of 10 or 15 mg idarubicin .

    Study part B
    • To compare the plasma C(t) for idarubicin and idarubicinol between the two doses of 10 or 15 mg idarubicin.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 h from administration
    E.5.2Secondary end point(s)
    Study part A
    • To evaluate tumour-uptake of lipiodol with computer tomography (CT).
    • To evaluate the anti-tumour effect defined as changes in tumour volume (evaluated with RECIST), and the amount of necrosis using positron emission tomography (PET) and magnetic resonance imaging (MRI).
    • To evaluate the effect of the IDA-lipiodol-emulsion on the regulation of the lipidome and proteome (metabolomics) of HCC and non-tumour cells with multi-omics analytical techniques in liver biopsies from tumour and nontumor tissues as well as liquid biopsies from blood/serum/plasma.
    • To explore changes in RNA-isolation, protein extraction and metabolomics/lipidomics assays in primary tumour material grown from liver biopsies cultured in 3D hydrogels in comparison with baseline.
    • To detect lipiodol in lymph ducts during TACE.
    • To evaluate cardiotoxicity, hematologic and liver safety, and other adverse events.

    Study part B
    • Pharmacokinetics (PK) endpoints:
    • Differences in plasma population C(t) clearance for IDA and IDAol between the two doses of 10 or 15 mg.

    • Imaging endpoints:
    • To quantify and localize Lipiodol deposition in the liver, reflecting the uptake of IDA, on CT after all TACE-treatments.
    • To assess tumour volume with RECIST1, and viability before and after all TACE-treatments on CT.
    • To investigate whether any differences between HCCs within and between patients identified in study part Aon pre-TACE MRIare correlated to overall treatment response (evaluated with RECIST), PFS, OS,and the occurrence and severity of adverse events
    • To detect lipiodol in lymph vessels at fluoroscopy during TACE.

    Biochemistry and cell biology endpoints:
    • To compare the plasma concentrations of α-fetoprotein before and after every TACE.
    • To detect circulating tumour cells in systemic blood circulation.
    • To compare the anti-tumour effect (amount of necrosis) achieved in vivo and in vitro in the same tumours and whether there is a correlation to any differences between HCCs within and between patients identified in study part A

    Safety endpoints:
    • To evaluate cardiotoxicity with plasma and blood serum concentrations of troponin I and N-terminal pro-brain natriuretic peptide (NT-proBNP), respectively.
    • To evaluate hematologic toxicity and liver safety with neutropenia and thrombocytopenia before and after treatment.
    • To evaluate liver safety with serum/plasma bilirubin and serum aminotransferase before and after treatment.
    • To evaluate clinical tolerability of the treatment.
    • To estimate quality of life
    •
    Overall endpoints:
    • To investigate whether the differences between HCCs detected with histopathology correlate with those detected with PET/MRI and/or any of the multi-omics techniques.
    • To evaluate the ability of single or combined imaging and multi-omics biomarkers to predict treatment response.
    • To evaluate progression-free and overall survival
    E.5.2.1Timepoint(s) of evaluation of this end point
    Lipiodol enhancement on CT 2 weeks after first and second TACE and anti-tumor response of treated lesion after 4-6 weeks assessed with PET/MRI.
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state30
    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)
    Patient continue with the clinical routine at the specific clinical site
    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 Decision2021-08-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-01
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 11 16:57:44 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA