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    Summary
    EudraCT Number:2012-005743-24
    Sponsor's Protocol Code Number:1214
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-07-02
    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 ConcernedAustria - BASG
    A.2EudraCT number2012-005743-24
    A.3Full title of the trial
    ACTIVITY AND SAFETY OF REGORAFENIB IN PATIENTS WITH METASTATIC
    SOFT TISSUE SARCOMA PREVIOUSLY TREATED WITH ANTHRACYCLIN-BASED CHEMOTHERAPY: A MULTINATIONAL, RANDOMIZED, PHASE II, PLACEBO-CONTROLLED TRIAL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II study of regorafenib as salvage therapy in metastatic soft tissue sarcoma
    A.3.2Name or abbreviated title of the trial where available
    REGO-SARC
    A.4.1Sponsor's protocol code number1214
    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 SponsorCentre Oscar Lambret
    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
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Oscar Lambret
    B.5.2Functional name of contact pointProject manager
    B.5.3 Address:
    B.5.3.1Street Address3 rue Frederique Combemale - BP 307
    B.5.3.2Town/ cityLille
    B.5.3.3Post code59020
    B.5.3.4CountryFrance
    B.5.4Telephone number33320295918
    B.5.5Fax number33320295896
    B.5.6E-maily-vendel@o-lambret.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 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 nameregorafenib
    D.3.4Pharmaceutical form 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.3.9.1CAS number 755037-03-7
    D.3.9.2Current sponsor coderegorafenib
    D.3.9.3Other descriptive nameREGORAFENIB
    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 placeboTablet
    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 soft tissue sarcoma
    E.1.1.1Medical condition in easily understood language
    Metastatic soft tissue sarcoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level HLGT
    E.1.2Classification code 10041299
    E.1.2Term Soft tissue sarcomas
    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
    To evaluate the progression-free survival (PFS)
    E.2.2Secondary objectives of the trial
    - To evaluate progression-free rate at 3 and 6 months (PFR-3 and PFR-6), time to progression, response rate, duration of response and overall survival
    - To explore the growth modulation index in patients receiving regorafenib after randomization
    - To evaluate toxicity according to NCI-CTC AE V4.0.
    Exploratory
    - To identify potential predictive factors for regorafenib response.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - To identify potential predictive factors for regorafenib response.
    E.3Principal inclusion criteria
    1. Age ≥18 years of age
    2. Histological documentation of soft tissue (including uterus) sarcoma with available FFPE blocks obtained. After amendment 4: eligible soft tissue sarcomas are non-adipocytic soft tissue sarcomas.
    3. Prior treatment with doxorubicin or other anthracyclin. Moreover, Patients eligible in the Cohort E must have received pazopanib
    4. Metastatic disease not amenable to surgical resection with curative intent
    5. Documentation of progression before study entry
    6. Measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by RECIST 1.1.
    7. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 Life expectancy of at least 3 months
    8. Adequate bone marrow, renal, and hepatic function, as evidenced by the following within 7 days of study treatment initiation:
    a. Absolute neutrophil count (ANC) ≥1,500/mm3
    b. Platelets ≥100,000/mm3
    c. Hemoglobin ≥9.0 g/dL
    d. Serum creatinine ≤1.5 x upper limit of normal (ULN)
    e. Glomerular filtration rate (GFR) ≥30 ml/min/1.73m2
    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 and 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 urinanalysis shows 1+ protein or more, a 24-hour urine collection will be required and must show total protein excretion <1000 mg/24 hours
    9. INR/PTT ≤1.5 x ULN
    10. 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. 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. Adequate contraception is defined as any medically recommended method (or combination of methods) as per standard of care.
    12. 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).
    13. In the assessment of the investigator, patient is able to comply with study requirements
    14. Signed, IRB-approved written informed consent
    E.4Principal exclusion criteria
    1. More than 4 lines of systemic treatment for metastatic sarcoma
    2. Histological subtypes listed in Appendix C (especially GIST, osseous sarcoma, embryonnal or alveolar rhabdomyosarcoma)
    Patients with liposarcoma are not eligible in the cohort E
    3. Primary bone sarcoma
    4. Prior treatment with regorafenib
    5. Known history of or concomitant malignancy likely to affect life expectancy in the judgment of the investigator
    6. Pregnant or breastfeeding patients. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment
    7. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of Day 1 of treatment
    8. Active cardiac disease including any of the following: Congestive heart failure (New York Heart Association [NYHA]) ≥Class 2, Unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months), Cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
    9. Uncontrolled hypertension. (Systolic blood pressure >150 mmHg or diastolic pressure >90 mmHg despite optimal medical management)
    10. Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism
    11. Ongoing infection >Grade 2 according to NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v. 4.0)
    12. Known history of human immunodeficiency virus (HIV) infection
    13. Known history of chronic hepatitis B or C
    14. Patients with seizure disorder requiring medication
    15. History of organ allograft
    16. Evidence or history of bleeding diathesis. Any hemorrhage or bleeding event > Grade 3 within 4 weeks of start of treatment
    17. Non-healing wound, ulcer, or bone fracture
    18. Renal failure requiring hemo- or peritoneal dialysis
    19. Dehydration according to NCI-CTC v 4.0 Grade >1
    20. Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
    21. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation
    22. Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
    23. Inability to swallow oral medications, Any malabsorption condition
    24. Pleural effusion or ascites that causes respiratory compromise (Grade 2 dyspnea)
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) according to modified Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and after central radiological review
    E.5.1.1Timepoint(s) of evaluation of this end point
    Disease progression
    E.5.2Secondary end point(s)
    1. Progression-free rate at 3 and 6 months (PFR-3 and PFR-6), time to progression, response rate and duration of response, overall survival according to RECIST 1.1 criteria
    2. Toxicity according to NCI-CTC AE V4.0
    3. Growth modulation index
    4. Potential predictive factors for regorafenib response …. Formalin fixed, paraffin embedded (FFPE) or fresh frozen tissue samples collected either from the primary tumor or from metastatic sites, or both will be analyzed.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 3 to 6 months
    2. LVLS
    3. Disease progression
    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 Yes
    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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 years5
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months9
    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: 192
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 192
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 192
    F.4.2.2In the whole clinical trial 192
    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)
    - Survival follow-up period
    Patients will enter the Survival Follow-up Period immediately following the safety follow-up visit. They will be evaluated every 3 months to determine their survival status. Telephone follow-up is acceptable.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation SPA – Sarcoma Platform - Austria
    G.4.3.4Network Country Austria
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-07
    P. End of Trial
    P.End of Trial StatusOngoing
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