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    Summary
    EudraCT Number:2012-005287-10
    Sponsor's Protocol Code Number:2012-PT023
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-05-21
    Trial results View 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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2012-005287-10
    A.3Full title of the trial
    A Phase III Double-blinded, Placebo Controlled Study of Xilonix™ for Improving Survival in Metastatic Colorectal Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Xilonix™ for Improving Survival in Colorectal Cancer
    A.4.1Sponsor's protocol code number2012-PT023
    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 SponsorXBiotech Germany GmbH
    B.1.3.4CountryGermany
    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 supportXBiotech Germany GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationXBiotech USA, Inc.
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address8201 E Riverside Drive, Building 4, Suite 100
    B.5.3.2Town/ cityAustin
    B.5.3.3Post code78744
    B.5.3.4CountryUnited States
    B.5.4Telephone number0015123862900
    B.5.6E-mailinfo@xbiotech.com
    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 nameXILONIX™
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNN/A
    D.3.9.2Current sponsor codeXILONIX
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastatic colorectal cancer
    E.1.1.1Medical condition in easily understood language
    Colorectal 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 10052362
    E.1.2Term Metastatic colorectal cancer
    E.1.2System Organ Class 100000016864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Overall survival (OS) will be the primary endpoint of this study, which will be measured from the date of randomization until death or last follow-up.
    E.2.2Secondary objectives of the trial
    •Secondary efficacy variables will include change in lean body mass (LBM) measured by dual-energy X-ray absorptiometry (DEXA) scans, change in Quality of Life assessed through the cancer-specific EORTC QLQ-C30 questionnaire, stabilization of platelet counts, progression free survival (PFS), objective response rate (ORR) and disease control rate (DCR).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects with pathologically confirmed colorectal carcinoma that is metastatic or unresectable and which is refractory to standard therapy. To be considered refractory, a subject must have experienced progression (or intolerance) after treatment with all of the following agents: oxaliplatin, irinotecan flouropyrimidine, bevacizumab, and cetuximab or panitumumab if KRAS wildtype.
    2. Subjects will not be treated with any radiation, chemotherapy, or investigational agents while enrolled in this protocol.
    3. Eastern Cooperative Oncology Group (ECOG) performance status 0,1, or 2.
    4. At least 2 weeks since the last previous cancer treatment including: chemotherapy, radiation therapy, immunotherapy, surgery, hormonal therapy, or targeted biologics and 4 weeks for patients who received treatment immediately prior to the study with anti-IL-1 or anti-TNF agents.
    5. Age ≥ 18 years, male or female subjects.
    6. Serum potassium and magnesium levels within Central Lab normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the lower limit of normal. Subjects with low potassium, calcium and magnesium levels may be replenished to allow for protocol.
    7. Adequate renal function, defined by serum creatinine ≤ 1.5 x ULN.
    8. Adequate hepatic function defined as:
    - total bilirubin ≤ 1.5 times the Central Lab upper limit ULN.
    - alanine aminotransferase (ALT) ≤ 2.0 times the Central Lab ULN.
    Exception: subjects with known liver metastases: ≤ 3.0 times the Central Lab ULN for ALT.
    9. Adequate bone marrow function as defined as:
    - absolute neutrophil count (neutrophil and bands) of ≥ 1,500/mm3 (≥ 1.5 x 10 ^9/L)
    - platelet count of ≥ 100,000/mm3 (≥100 x10^9/L)
    - hemoglobin of ≥ 9 g/dL
    10. For women of childbearing potential (WOCBP), a negative serum pregnancy test result at Screening and monthly thereafter.
    For women who are not postmenopausal (24 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use adequate methods of contraception, during the treatment period and for at least 1 month after the last dose of study drug.
    Acceptable contraceptive measures include:
    - Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: Oral, Intravaginal or transdermal
    - Progestogen-only hormonal contraception associated with inhibition of ovulation; Oral, injectable, implantable, intrauterine device (IUD), intrauterine hormone-releasing system(IUS)
    - Barrier or sterilization methods such as condoms, bilateral tubalocclusion, vasectomized partner or sexual abstinence
    For men: agreement to use a barrier method of contraception during the treatment period and for at least 1 month after the last dose of study drug.
    11. Signed and dated institutional review board (IRB)-approved informed consent before any protocol-specific screening procedures are performed.
    12. Patients enrolled must, in the Investigator’s judgment, be healthy enough to stay on the clinical trial for three months.
    E.4Principal exclusion criteria
    1. Mechanical obstruction that would prevent a patient from receiving adequate nutritional intake.
    2. A serious uncontrolled medical disorder or active infection that would impair the ability of the patient to receive protocol therapy.
    3. Uncontrolled or significant cardiovascular disease, including:
    - A myocardial infarction within 6 months
    - Uncontrolled angina within 3 months
    - Congestive heart failure within 3 months defined as NYHC-II New York Heart Association (HYHA) Classes II or higherHYNC
    - Diagnosed or suspected congenital long QT syndrome
    - Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, Wolff-Parkinson-White (WPW) syndrome, or torsade de pointes).
    - Any history of second or third degree heart block (may be eligible if currently have a pacemaker)
    - Uncontrolled hypertension (blood pressure >140 mm Hg systolic and >90 mm Hg diastolic).
    4. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
    5. Subjects who have not recovered from the adverse effects of prior therapy at the time of enrollment to ≤ grade 1; excluding alopecia and grade 2 neuropathy.
    6. Immunocompromised subjects, including subjects known to be infected with human immunodeficiency virus (HIV)
    7. Known hepatitis B surface antigen and/or positive hepatitis C antibody and presence of hepatitis C RNA.
    8. History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA)
    9. Receipt of a live (attenuated) vaccine within 1 month prior to screening
    10. Subjects with history of hypersensitivity to compounds of similar chemical or biologic composition to Xilonix
    11. Women who are pregnant or breastfeeding
    12. WOCBP or men whose sexual partners are WOCBP who are unwilling or unable to use an acceptable method of contraception for at least 1 month prior to study entry, for the duration of the study, and for at least 1 month after the last dose of study medication.
    13. Weight loss >20% in the previous 6 months.
    14. History of progressive multifocal leukoencephalopathy or other demyelinating disease
    15. Subjects on immunosuppressive therapy, including transplant patients
    E.5 End points
    E.5.1Primary end point(s)
    Overall survival (OS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    from the date of randomization until death or last follow-up
    E.5.2Secondary end point(s)
    - change in lean body mass (LBM) measured by dual-energy X-ray absorptiometry (DEXA) scans,
    - change in Quality of Life assessed through the cancer-specific EORTC QLQ-C30 questionnaire,
    - stabilization of platelet counts,
    - progression free survival (PFS),
    - objective response rate (ORR)
    - disease control rate (DCR).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Until death or last follow-up
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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) 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    Bulgaria
    Czech Republic
    Georgia
    Hungary
    Poland
    Russian Federation
    Serbia
    United States
    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
    LPLV or 552 deaths, whichever comes first
    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 months5
    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 months5
    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: 360
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 240
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 600
    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 Decision2015-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-07
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