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    Summary
    EudraCT Number:2018-001574-22
    Sponsor's Protocol Code Number:EREMISS-1801
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-07-24
    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 number2018-001574-22
    A.3Full title of the trial
    Efficacy of regorafenib as maintenance therapy in non-adipocytic soft tissue sarcoma having received first-line doxorubicin-based chemotherapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy of regorafenib as maintenance therapy in non-adipocytic soft tissue sarcoma having received first-line doxorubicin-based chemotherapy
    A.3.2Name or abbreviated title of the trial where available
    EREMISS
    A.4.1Sponsor's protocol code numberEREMISS-1801
    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 sponsor
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    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 pointSponsor unit
    B.5.3 Address:
    B.5.3.1Street Address3 rue Fréfdéric Combemale BP 307
    B.5.3.2Town/ cityLille
    B.5.3.3Post code59020
    B.5.3.4CountryFrance
    B.5.4Telephone number03 20 29 59 18
    B.5.5Fax number03 20 29 58 96
    B.5.6E-mailpromotion@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 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.3.1Product 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.3.9.3Other descriptive nameREGORAFENIB
    D.3.9.4EV Substance CodeSUB73090
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10075333
    E.1.2Term Soft tissue sarcoma
    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 assess the efficacy, in terms of PFS, of regorafenib compared to placebo as maintenance therapy in metastatic soft-tissue, non-adipocytic sarcomas experiencing stable disease or partial tumor response after 6 cycles of doxorubicin-based chemotherapy as 1st line chemotherapy
    E.2.2Secondary objectives of the trial
    • To assess the efficacy of regorafenib compared to placebo in terms of overall survival, best response, and time to start subsequent line of anticancer therapy
    • To assess the safety of regorafenib compared to placebo
    • To assess the relative benefit/risk ratio using the Q-TWiST approach
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Sub-study pending - will be set up once grants are obtained. The objective will be to validate the predictive value of SUMSCAN signature.
    E.3Principal inclusion criteria
    1. Age ≥18 years
    2. Histologically proven soft tissue sarcoma including leiomyosarcoma, synovial sarcoma and other sarcomas (confirmation of diagnosis by expert pathologist from the RRePS network)
    3. Patients in partial response or stable disease after 6 cycles of doxorubicin-based first-line chemotherapy for metastatic/locally advanced soft tissue sarcoma
    4. Metastatic/locally advanced disease not amenable to surgical resection with curative intent
    5. Eastern Cooperative Oncology Group (ECOG) Performance Status =0 or 1
    6. Measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by RECIST 1.1.
    7. Available tumor tissue for translational research program
    8. Adequate bone marrow, renal, and hepatic function, as evidenced by the following tests performed within 7 days of study treatment initiation:
    - Absolute neutrophil count (ANC) ≥1,500/mm3
    - Platelets ≥100,000/mm3
    - Hemoglobin ≥9.0 g/dL
    - Serum creatinine ≤1.5 x upper limit of normal (ULN)
    - Glomerular filtration rate (GFR) ≥30 mL/min/1.73m2
    - AST and ALT ≤2.5 x ULN (≤5.0 × ULN for patients with liver involvement of their cancer)
    - Bilirubin ≤1.5 X ULN
    - Alkaline phosphatase ≤2.5 x ULN (≤5 x ULN with liver involvement of their cancer)
    - Amylase and/or lipase ≤1.5 x ULN
    9. Spot urine must not show 1+ or more protein in urine or the patient will require a repeat urine analysis. If repeated urine analysis 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
    11. 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.
    12. Women of childbearing potential and male subjects 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.
    13. Recovery to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0 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).
    14. In the assessment of the investigator, patients are able to comply with study requirements
    15. Signed, IRB-approved written informed consent
    E.4Principal exclusion criteria
    1. Prior adjuvant or neoadjuvant chemotherapy not allowing at least 6 cycles of doxorubicin-based chemotherapy at metastatic stage
    2. Complete response to 1st line chemotherapy
    3. Disease progression during the 1st line of chemotherapy
    4. Time interval between the last cycle of doxorubicin-based chemotherapy superior to 8 weeks
    5. Primary bone sarcoma
    6. All forms of liposarcoma
    7. Some particular histologic types, i.e., PNET/Ewing, alveolar or embryonal rhabdomyosarcoma, Perivascular epithelioid cell sarcoma (PEComa), low grade endometrial stromal tumor, desmoid tumor
    8. Prior treatment with tyrosine kinase inhibitor
    9. Known history of or concomitant malignancy likely to affect life expectancy in the judgment of the investigator
    10. Pregnant or breastfeeding patients. Women of childbearing potential must have a pregnancy test performed a maximum of 7 days before start of treatment
    11. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of Day 1 of treatment
    12. 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)
    13. Uncontrolled hypertension (Systolic blood pressure >150 mmHg or diastolic pressure >90 mmHg despite optimal medical management)
    14. Arterial or venous thrombotic or embolic events such as myocardial infarction, cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism within 6 months of starting on study drug
    15. Any hemorrhage or bleeding event > Grade 4 within 4 weeks of start of treatment
    16. Ongoing infection >Grade 2 according to NCI Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v. 5.0)
    17. Known history of human immunodeficiency virus (HIV) infection
    18. Known history of chronic hepatitis B or C
    19. Patients with seizure disorder requiring medication
    20. History of organ allograft
    21. Evidence or history of bleeding diathesis. Any hemorrhage or bleeding event > Grade 4 within 4 weeks of start of treatment
    22. Non-healing wound, ulcer, or bone fracture
    23. Renal failure requiring hemo- or peritoneal dialysis
    24. Dehydration according to NCI-CTCAE v. 5.0 Grade >1
    25. Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
    26. Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation
    27. Interstitial lung disease with ongoing signs and symptoms at the time of informed consent
    28. Inability to swallow oral medications, Any mal-absorption condition
    29. Pleural effusion or ascites that causes respiratory compromise (Grade 2 dyspnea)
    E.5 End points
    E.5.1Primary end point(s)
    progression-free survival according to RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    From date of randomization until the date of first documented progression or date of death from any cause
    E.5.2Secondary end point(s)
    1) Overall survival, defined as the time interval from the date of randomization to the date death from any cause. Patient data will be censored at the date of last follow-up visit for patients alive at last follow-up visit.
    2) Overall best response according to RECIST 1.1 evaluated by central radiological review: Complete Response, CR, or Partial Response, PR achieved during the maintenance therapy
    3) Time to start a further cancer therapy
    4) Safety and toxicity according to NCI-CTC AE V4
    5) Quality-adjusted time without symptoms of disease or toxicity (Q-TWiST)
    6) Additional exploratory objective, this Phase II trial will be used with the aim of assessing the predictive value of SUMSCAN signature (genomic signature established on initial diagnostic biopsies or resection specimen and identifying sarcoma patients benefitting from anti-angiogenetic agents)
    E.5.2.1Timepoint(s) of evaluation of this end point
    From date of randomization until the date of first documented progression or date of death from any cause
    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 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 concerned15
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state126
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Groupe Sarcome Français GSF-GETO
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-08-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-19
    P. End of Trial
    P.End of Trial StatusCompleted
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