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    Summary
    EudraCT Number:2014-000550-12
    Sponsor's Protocol Code Number:2014-PT026
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-09
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2014-000550-12
    A.3Full title of the trial
    A Double Blind, Placebo Controlled, Pivotal Phase III Study Evaluating Xilonix™ in Symptomatic Colorectal Cancer Patients Refractory To Standard Therapy
    Dvojitě zaslepená, placebem kontrolovaná pivotní studie III. fáze, hodnotící XILONIX™ u pacientů s kolorektálním karcinomem refrakterním ke standardní terapii.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study Evaluating Xilonix™ in Symptomatic Colorectal Cancer Patients Refractory To Standard Therapy
    A.4.1Sponsor's protocol code number2014-PT026
    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 number001512-386-2900
    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 infusion
    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 placeboConcentrate for solution for infusion
    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
    Symptomatic 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 18.0
    E.1.2Level PT
    E.1.2Classification code 10061451
    E.1.2Term Colorectal cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Efficacy Endpoint:
    • The primary endpoint of this study will be the objective response rate (ORR), a composite measure consisting of change in lean body mass (LBM) and change in quality of life, from screening to week 8. The ORR will be defined as a stabilization or positive (≥0 kg) change in lean body mass (LBM)—as assessed by dual-energy X-ray absorptiometry (DEXA) scan, and improvement or no worsening (≥0 score point change) on any two of the three symptom scale measures (fatigue, pain, appetite) of EORTC QLQ-C30.
    E.2.2Secondary objectives of the trial
    Secondary Endpoints:
    • Secondary efficacy endpoints include measures of key cancer symptoms, as well as pharmacodynamics parameters. Parameters to be measured are: (1) change in functional scales and (2) global QoL as assessed by the EORTC QLQ-C30 questionnaire at screening and 8 week follow-up; (3) reduction in serum IL-6; and (4) stabilization of platelet count at 8 week compared to screening.
    • Safety and tolerability of Xilonix™ as compared to placebo control.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects are included in the study if they meet all of the following 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 failed both an oxaliplatin (oxaliplatin may have been in the adjuvant setting) and an irinotecan based regimen.
    2. Symptomatic Disease: One symptom from each domain (metabolic and functional) must be present.
    - Evidence of metabolic dysfunction, defined as the presence of one or more of the following:
    - Any degree (up to 20%) of unintentional total body weight loss in the previous 6 months
    - Serum Interleukin 6 levels ≥10 pg/ml
    - Evidence of reduced function or presence of cancer related symptoms as determined by EORTC QLQ-C30.
    - Appetite reduction, with a score of >10
    - Presence of fatigue, with a score of >10
    - Presence of Pain, with a score of >10
    - Decreased Role, Emotional and Social function, with a score of < 90.
    3. Eastern Cooperative Oncology Group (ECOG) performance status 1 or 2.
    4. In the Investigator’s judgment, a life expectancy of at least three (3) months.
    5. In the Investigator’s judgement, patients should not need corticosteroids during the 8 week assessment period.
    6. 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.
    7. For those subjects who have previously received treatment for cancer related fatigue with agents such as corticosteroids or stimulants, a 2 week washout period is required from the last dose to C1D1.
    8. Age ≥18, male or female subjects.
    9. Serum potassium and magnesium levels within central laboratory 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 entry.
    10. Adequate renal function, defined by serum creatinine ≤ 1.5 x ULN.
    11. Adequate hepatic function defined as:
    - total bilirubin ≤ 1.5 times the central lab 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.
    12. Adequate bone marrow function as defined as:
    - absolute neutrophil count (neutrophil and bands) of  1,500/mm3 ( 1.5 x 109/L)
    - platelet count between 150,000/mm3 and 450,000/mm3
    - hemoglobin of ≥ 9 g/dL
    13. For women of childbearing potential (WOCBP), a negative serum pregnancy test result at Screening.
    14. Signed and dated institutional review board (IRB)/ Ethics Committee (EC)-approved informed consent before any protocol-specific screening procedures are performed.
    E.4Principal exclusion criteria
    Subjects with ANY of the following will be excluded from the study:
    1. Mechanical obstruction that would prevent adequate oral nutritional intake.
    2. >20% total body weight loss in the previous 6 months.
    3. Serious uncontrolled medical disorder, or active infection, that would impair the ability of the patient to receive protocol therapy.
    4. Uncontrolled or significant cardiovascular disease, including:
    - A myocardial infarction within the past 6 months.
    - Uncontrolled angina within the past 3 months.
    - Congestive heart failure within the past 3 months, if defined as NYHC-II.
    - 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 >150 mm Hg systolic and >95 mm Hg diastolic).
    5. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent.
    6. 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.
    7. Subjects who have received extensive prior radiation therapy to the bone marrow. Extensive radiation therapy is defined as treatment of more than one axial bony metastasis. However for subjects with rectal cancer pelvic irradiation, in addition to treatment of one axial bony metastasis, is acceptable.
    8. Immunocompromised subjects, including subjects known to be infected with human immunodeficiency virus (HIV).
    9. Known hepatitis B surface antigen and/or positive hepatitis C antibody or known history of infection.
    10. History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA).
    11. Receipt of a live (attenuated) vaccine within 1 month prior to Randomization
    12. Subjects with history of hypersensitivity to compounds of similar chemical or biologic composition to Xilonix™ or any component of its formulations.
    13. Women who are pregnant or breastfeeding.
    14. 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 randomization, for the duration of the study, and for at least 3 months after the last dose of study medication.
    15.History of progressive multifocal leukoencephalopathy or other demyelinating disease.
    16.Subjects on immunosuppressive therapy, including transplant patients.
    17. Subjects with known brain metastases. Subjects with symptoms of brain metastases during screening should undergo CT imaging prior to randomization.


    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study will be the objective response rate (ORR), a composite measure consisting of change in lean body mass (LBM) and change in quality of life, from screening to week 8. The ORR will be defined as a stabilization or positive (≥0 kg) change in lean body mass (LBM)—as assessed by dual-energy X-ray absorptiometry (DEXA) scan, and improvement or no worsening (≥0 score point change) on any two of the three symptom scale measures (fatigue, pain, appetite) of EORTC QLQ-C30.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints include measures of key cancer symptoms, as well as pharmacodynamics parameters. Parameters to be measured are: (1) change in functional scales and (2) global QoL as assessed by the EORTC QLQ-C30 questionnaire at screening and 8 week follow-up; (3) reduction in serum IL-6; and (4) stabilization of platelet count at 8 week compared to screening.
    • Safety and tolerability of Xilonix™ as compared to placebo control.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 8
    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 Yes
    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
    tolerability, objective response rate
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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
    France
    Georgia
    Germany
    Hungary
    Poland
    United Kingdom
    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
    last visit of the 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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months3
    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: 166
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 110
    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 251
    F.4.2.2In the whole clinical trial 276
    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)
    After week 8, subjects from both arms can receive Xilonix™ in an open label extension. Patients who decide to terminate the study will receive standard of care.
    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 Decision2014-09-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-07
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