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    Summary
    EudraCT Number:2017-002517-64
    Sponsor's Protocol Code Number:BTG-002814-02
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-07-06
    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 ConcernedUK - MHRA
    A.2EudraCT number2017-002517-64
    A.3Full title of the trial
    An open label, single-arm, Phase I/II study of vandetanib-eluting radiopaque embolic beads (BTG-002814) in patients with hepatocellular carcinoma (HCC) without curative options
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial of tiny beads linked to an anti-cancer drug (vandetanib) injected into liver tumours
    A.3.2Name or abbreviated title of the trial where available
    VALENCIA
    A.4.1Sponsor's protocol code numberBTG-002814-02
    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 SponsorBiocompatibles UK Ltd
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBiocompatibles UK Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPrn Clinical Services
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressGrove House, Lutyens Close, Chineham Court
    B.5.3.2Town/ cityBasingstoke
    B.5.3.3Post codeRG248AG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441256316551
    B.5.6E-mailpread@prnservices.co.uk
    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.2.5The 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 nameVandetanib Eluting Radiopaque Bead
    D.3.2Product code BTG-002814
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraarterial 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Hepatocellular Carcinoma (HCC)
    E.1.1.1Medical condition in easily understood language
    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 20.0
    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
    To assess the safety and tolerability of BTG-002814
    To identify the Recommended Dose (RD) of BTG-002814
    E.2.2Secondary objectives of the trial
    To evaluate the pharmacokinetics of vandetanib and the N-desmethyl metabolite
    To assess the anti-tumour activity according to Modified Response Evaluation Criteria in Solid Tumours (mRECIST) and Response Evaluation Criteria in Solid Tumours (RECIST 1.1) criteria
    To evaluate the changes in serum alpha fetoprotein (AFP) levels following treatment with BTG-002814
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female adults (≥18 years old)
    2. Primary confirmed diagnosis of HCC according to the EASL criteria or histology
    3. Patient is a candidate for TACE and is not eligible or amenable for curative treatment (resection, liver transplantation or percutaneous ablation)
    4. Part A: Patients with unilobar tumours. Patient must have a single tumour diameter of 5 cm or more or multiple tumours with the sum of the diameters being 8 cm or more
    Part B: Patients with unilobar or bilobar tumours. For bilobar tumours, both lobes must be able to be treated in the same session
    5. Measurable disease according to mRECIST and RECIST 1.1
    6. Performance Status ECOG 0 or 1
    7. Part A: Patients with well preserved liver function (Child-Pugh A with no clinically detectable ascites, or if minor ascites on imaging, the patients must have no diuretic medication).
    Part B: Patients with Child-Pugh A or B7
    8. Adequate haematological function with Hb >90 g/L, absolute neutrophil count (ANC) >1.5 x 109/L, Plt >75 x 109/L, INR ≤1.5
    9. Adequate liver function with serum bilirubin <1.5 x ULN, ALT (or AST if ALT not available) ≤5 x ULN, ALP <5 x ULN, serum albumin >28 g/L
    10. Adequate renal function with serum creatinine ≤1.5 x ULN and calculated creatinine clearance (GFR ) ≥50 mL/min estimated using a validated creatinine clearance calculation (e.g. Cockroft-Gault or Wright formula).
    11. Patient is able and willing to participate in the study and has provided written informed consent
    E.4Principal exclusion criteria
    1. Advanced tumoural disease, vascular invasion (VP3, VP4) of the tumour extrahepatic spread
    2. Patients previously treated in the same liver lobe with transarterial embolisation (with or without chemotherapy) of the liver, prior radiotherapy or prior yttrium-90 microsphere therapy
    3. Patients who are currently on the liver transplant waiting list
    4. Part A: Patients with bilobar disease
    5. Part A: Advanced liver disease patients who are Child-Pugh >A6 or who have active gastrointestinal bleeding
    Part B: Advanced liver disease patients who are Child-Pugh >B7 or who have active gastrointestinal bleeding
    6. Any contraindication to vandetanib according to its label including:
    a.Hypersensitivity to the active substance
    b. Congenital long QTc syndrome.
    c. Patients known to have a QTc interval over 480 milliseconds.
    d. Concomitant use of medicinal products also known to also prolong the QTc interval and/or induce Torsades de pointes (See Appendix 1)
    7. Any contraindication to hepatic artery catheterisation or hepatic embolisation procedures (e.g. portal venous thrombosis, severely reduced portal venous flow or hepatofugal blood flow, untreated varices at high risk of bleeding) biliary obstruction, bilio-enteric anastomosis and incompetent ampulla of vater
    8. Women of childbearing potential not using effective contraceptive methods or women who are breast feeding
    9. Confirmed allergy to iodine-based intravenous contrast media that cannot be managed with standard of care
    10. Any co-morbid disease or condition or event that, in the Investigator’s judgment, would place the patient at undue risk, that and would preclude the safe use of treatment with BTG-002814
    11. Patients who cannot have Computerized Tomography (CT) imaging (according to site policy)
    12. Levels of potassium, calcium, magnesium or Thyroid Stimulating Hormone (TSH) outside the normal ranges, and that in the Investigator’s judgement are clinically significant, or laboratory findings that in the view of the Investigator makes it undesirable for the patient to participate in the study
    13. History of second malignancy (except those treated with curative intent for more than three years previously without relapse) and non-melanoma skin cancer or cervical carcinoma in situ
    14. Patients who have received treatment in another clinical study with an investigational product within 4 weeks prior to the screening visit.
    15. Concomitant treatment with any other anti cancer treatment (chemotherapy, targeted therapy, immunotherapy, Chinese medicine)
    16. Patients previously treated with any systemic anti-cancer therapy for HCC
    E.5 End points
    E.5.1Primary end point(s)
    Adverse Events (AEs) related to treatment with BTG-002814 using the standardised grading criteria (National Cancer Institute-Common Terminology Criteria for Adverse Events-Version 4.0 (NCI-CTCAE v4.0))
    E.5.1.1Timepoint(s) of evaluation of this end point
    Adverse events:
    Part A - At all visits from treatment to end of study (up to 7 weeks)
    Part B - At all visits from treatment to end of study (up to 26 weeks)
    E.5.2Secondary end point(s)
    PK profile of vandetanib and the N-desmethyl metabolite
    Objective response rate (ORR) according to mRECIST and RECIST 1.1 at 4 weeks, 3 and 6 months following first treatment
    Time to progression (TTP) according to mRECIST and RECIST 1.1
    Disease Control Rate (DCR) according to mRECIST and RECIST 1.1 at 4 weeks, 3 and 6 months following first treatment
    Change in AFP levels from baseline
    Blood biomarkers
    Hepatic time to progression (hTTP) according to mRECIST and RECIST 1.1
    E.5.2.1Timepoint(s) of evaluation of this end point
    PK Profile: Part A - pre-dose, and at 20, 60, and 90 minutes and at 2, 4, 8, 12, and 24 hours after start of the treatment. Thereafter, plasma samples will be obtained at 3, 7, 14, 21, 28 and 48 days.
    Objective response rate: 4 weeks, 3 and 6 months
    Disease control rate: 4 weeks, 3 and 6 months
    AFP Levels: Baseline to end of study
    Blood Biomarkers: Baseline to end of study
    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 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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose escalation
    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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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
    France
    Switzerland
    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
    Last visit of last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial 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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 48
    F.4.2.2In the whole clinical trial 56
    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
    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 Decision2017-08-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-05-16
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