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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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).

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    Summary
    EudraCT Number:2013-003910-42
    Sponsor's Protocol Code Number:UC-0150/1309_SARCOME_12
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-08-24
    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 ConcernedFrance - ANSM
    A.2EudraCT number2013-003910-42
    A.3Full title of the trial
    A Randomized Phase II, placebo-controlled , multicenter study evaluating efficacy and safety of regorafenib in patients with metastatic bone sarcomas.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    _
    A.3.2Name or abbreviated title of the trial where available
    REGOBONE
    A.4.1Sponsor's protocol code numberUC-0150/1309_SARCOME_12
    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 SponsorUNICANCER
    B.1.3.4CountryFrance
    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 supportBAYER HealthCare AG
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUNICANCER
    B.5.2Functional name of contact pointKarine BUFFARD, Project Manager
    B.5.3 Address:
    B.5.3.1Street Address101 rue de Tolbiac
    B.5.3.2Town/ cityParis Cedex 13
    B.5.3.3Post code75654
    B.5.3.4CountryFrance
    B.5.4Telephone number01 44 23 55 77
    B.5.5Fax number01 44 23 55 69
    B.5.6E-mailk-buffard@unicancer.fr
    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 STIVARGA
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Pharma AG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNREGORAFENIB
    D.3.9.2Current sponsor codeREGORAFENIB
    D.3.9.4EV Substance CodeSUB73090
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 placeboCoated tablet
    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
    Metastatic bone sarcomas: conventional high grade osteosarcoma, Ewing sarcoma of bone, intermediate or high-grade chondrosarcomas.
    E.1.1.1Medical condition in easily understood language
    Bone Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10008736
    E.1.2Term Chondrosarcoma metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10015562
    E.1.2Term Ewing's sarcoma metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level PT
    E.1.2Classification code 10031294
    E.1.2Term Osteosarcoma metastatic
    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
    The principal objective of the trial is to investigate the antitumor activity of regorafenib in terms of progression Free Survival (PFS) according to modified RECIST (RECIST 1.1) after central radiological review.
    E.2.2Secondary objectives of the trial
    1. Objective response rate [defined as complete response (CR) or partial response according to RECIST 2009, version 1.1] ;
    2. Disease control rate at 6 months (defined as the proportion of patients who a best response rating of CR, PR or stable disease [SD]), SD should be at least 8 weeks ;
    3. Overall survival (defined as the time from the date of randomization until the date of death due to any cause); if the patients is alive at the date of data base cut off then he will be censored at the data base cut off date;
    4.Duration of response (defined as the time from date of first documented objective response of CR or PR, whichever is noted earlier, to first disease progression or death before progression ;
    5. Progression-free rate at 3 and 6 months (PFR-3 and PFR-6), defined as the proportion of patients without progression at 3 and 6 months post randomization;
    6. Time to progression (measured from date of randomization until the date of first observation of progression );
    7. Growth Modulation Index defined as ratio of time to PD under regorafenib to TTP under previous treatment. The GMI will be explored in patients receiving regarafenib after randomization.
    8. Identification and characterization of biomarkers

    Toxicity according to NCI-CTC V4.0.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenomic study that the objectives are :

    • Identification and characterization of biomarkers: protein expression signature that can potentially be used as predictive markers of response to regorafinib.
    • Better definition of the patient population most sensitive to regorafinib.
    E.3Principal inclusion criteria
    1. Patients must have histologically confirmed diagnosis of bone sarcoma (osteosarcoma, Ewing sarcoma of bone, chondrosarcoma) with available Formalin Fixed Paraffin Embedded (FFPE) blocks obtained for centralized review;
    2. Patients with confirmed disease progression at study entry. The “baseline” radiological evaluation should demonstrate disease progression by RECIST V 1.1 when compared to a prior disease assessment done within a prior period of 3 month for osteosarcoma and Ewing sarcomas and within 6 month period for chondrosarcomas prior to screening
    Note: radiographic progression of disease will be based on at least 2 sets of scans (either MRI or CT) in the 3-month (for osteosarcomas and Ewing sarcoma) or 6-month period for chondrosarcoma prior to or during screening in which radiographic progression of disease , as defined by RECIST , is demonstrated. No central review of scans (either MRIs or CTs) will be required for study eligibility; these scans must be sent for central review within 10 days after randomization;
    3. Metastatic disease not amenable to surgical resection or radiation with curative intent;
    4. Patients must have measurable disease (outside any previous irradiated field) defined as at least one unidimensionally lesion that can be accurately measured as ≥ 10 mm with CT scan according to RECIST V1.1;
    5. Prior treatment :
    at least one, but no more than two prior (combination) chemotherapy regimen for metastatic disease; neo-adjuvant /maintenance therapy are not counted towards this requirement. At least 4 weeks since last chemotherapy (6 weeks in case of nitrosoureas and mitomycin C), immunotherapy or any other pharmacological treatment and/or radiotherapy;
    6. Age ≥ 18 years;
    7. Life expectancy of greater than 3 months;
    8. ECOG performance status < 2 (Karnofsky ≥ 60%);
    9. Patients must have adequate bone marrow, renal, and hepatic function, as evidenced by the following within 7 days of study treatment initiation : normal organ function as defined below :
    a. Absolute neutrophil count ≥ 1.5 Giga/L
    b. Platelets ≥ 100 Giga/L
    c. Hemoglobin≥ 9 d/dL
    d. Serum creatinin ≤ 1.5 x ULN
    e. Glomerular filtration rate (GFR) ≥30 ml/min/1.73m2 according to the modified Diet in Renal Disease (MDRD) abbreviated formula
    f. AST and ALT ≤2.5 x ULN ( ≤5.0 × ULN for patients with liver involvement of their cancer
    g. Bilirubin ≤1.5 X ULN
    h. Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN with liver involvement of their cancer)
    i. Amylase or lipase ≤1.5 x ULN
    j. Spot urine must not show 1+ or more protein in urine or the patient will require a repeat urine analysis. If repeat urinalysis shows 1+ protein or more, a 24-hour urine collection will be required and must show total protein excretion <1000 mg/24 hours
    10. INR/PTT ≤1.5 x ULN;
    Patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care;
    11. Recovery to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4.0 Grade 0 or 1 level or recovery to baseline preceding the prior treatment from any previous drug/procedure related toxicity (except alopecia, anemia, and hypothyroidism);
    12. Women of childbearing potential and male patients must agree to use adequate contraception for the duration of study participation and up to 3 months following completion of therapy;
    13. Women of childbearing potential must have a negative serum β-HCG pregnancy test within 7 days prior randomisation and/or urine pregnancy test within 48 hours before the first administration of the study treatment;
    14. Patients who have received the information sheet, dated and signed the informed consent form;
    15. Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures;
    16. Patients affiliated to the Social Security System.
    E.4Principal exclusion criteria
    1. Prior treatment with any VEGFR inhibitor (thus, any prior exposure to sunitinib, sorafenib, pazopanib, bevacizumab, or other VEGFR inhibitor would render the patient ineligible for this study);
    2. Low grade histological subtypes: low grade chondrosarcomas, low grade osteosarcoma, paraosteal/periosteal osteosarcoma;
    3. Soft tissue sarcoma (including Ewing soft tissue sarcoma);
    4. Other cancer (different histology) within 5 years prior to randomization;
    5. Major surgical procedure, open biopsy, significant trauma, within the last 28 days before randomization;
    6. Cardiovascular dysfunction:
    - Congestive heart failure (New York Heart Association [NYAH]) ≥ 2,
    - Myocardial infarction <6 months before study
    - Cardiac arrhythmias requiring therapy (beta blockers or digoxin are permitted)
    - Uncontrolled hypertension (systolic blood pressure > 150mmHg or diastolic pressure > 90mmHg despite optimal treatment)
    - Unstable (angina symptoms at rest) or new-onset angina (begun within the last 3 months);
    7. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within the last 6 months before randomization;
    8. Severe hepatic impairment (Child-Pugh C);
    9. Ongoing infection > Grade 2 according to NCI-CTCAE v4.0;
    10. Known history of human immunodeficiency virus (HIV) infection;
    11. Known history of chronic hepatitis B or C;
    12. Difficulties with swallowing study tablets;
    13. Prior anticancer therapy, including radiotherapy, endocrine therapy, immunotherapy, chemotherapy (CT) within the last 4 weeks (6 weeks for nitrosoureas and mitomycin C), or other investigational agents ; Concomitant antalgic palliative radiotherapy allowed.
    14. Concurrent enrolment in another clinical trial in which investigational therapies are administered;
    15. Known hypersensitivity to the active substance or to any of the excipients;
    16. Pregnant women, women who are likely to become pregnant or are breast-feeding;
    17. Individual deprived of liberty or placed under the authority of a tutor;
    18. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial;
    19. Patients with history of non compliance to medical regimens or unwilling or unable to comply with the protocol.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is PFS [defined using RECIST 1.1] after central radiological review Progression-Free Survival will be measured from the date of randomization until the date of radiological progression or death whatever the cause (if death occurs before progression).
    E.5.1.1Timepoint(s) of evaluation of this end point
    _
    E.5.2Secondary end point(s)
    1. Objective response rate [defined as complete response (CR) or partial response (PR) according to RECIST 2009, version 1.1] ;
    2. Disease control rate at 6 months (defined as the proportion of patients who a best response rating of CR, PR or stable disease [SD]), SD should be at least 8 weeks ;
    3. Overall survival (defined as the time from the date of randomization until the date of death due to any cause); if the patients is alive at the date of data base cut off then he will be censored at the data base cut off date;
    4. Duration of response (defined as the time from date of first documented objective response of CR or PR, whichever is noted earlier, to first disease progression or death before progression ;
    5. Progression-free rate at 3 and 6 months (PFR-3 and PFR-6), defined as the proportion of patients without progression at 3 and 6 months post randomization;
    6. Time to progression (measured from date of randomization until the date of first observation of progression );
    7. Growth Modulation Index defined as ratio of time to PD under regorafenib to TTP under previous treatment. The GMI will be explored in patients receiving regarafenib after randomization.
    8. Identification and characterization of biomarkers
    Toxicity according to NCI-CTC V4.0.
    E.5.2.1Timepoint(s) of evaluation of this end point
    _
    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 Yes
    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 concerned18
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 54
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 state108
    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 Decision2014-05-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-06
    P. End of Trial
    P.End of Trial StatusOngoing
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