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    Summary
    EudraCT Number:2010-022687-12
    Sponsor's Protocol Code Number:STREAM
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-12-14
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-022687-12
    A.3Full title of the trial
    A Randomized Discontinuation, Blinded, Placebo-Controlled, Phase II Study of Sorafenib in Patients with Chemonaïve Metastatic Uveal Melanoma
    (Sorafenib Treatment of Metastatic Uveal Melanoma)
    A.4.1Sponsor's protocol code numberSTREAM
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversitätsklinikum Essen
    B.1.3.4CountryGermany
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Nexavar
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Schering 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 nameSorafenib
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNSORAFENIB
    D.3.9.1CAS number 284461-73-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboFilm-coated 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
    choroid melanoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10008773
    E.1.2Term Choroid melanoma
    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 determine progression free survival (PFS) of sorafenib versus placebo after random assignment (randomized subset only).
    E.2.2Secondary objectives of the trial
    To compare safety and tolerability in randomization phase

    The following secondary objectives refer to all patients enrolled:
    - To determine median overall survival
    - To determine disease control rate (DCR)
    - To determine overall PFS and time to progression (TTP)
    - To determine response rate
    - To determine whether tumor markers correlate with clinical benefit and whether
    tumor markers in run-in phase predict clinical benefit
    - To determine PFS and TTP after unblinding and retreatment with sorafenib
    (only in subjects randomized to placebo and retreated with sorafenib)
    - Safety and tolerability
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated written informed consent before the start of specific protocol procedures
    2. Metastatic uveal melanoma with histological or cytological confirmation of liver metastasis (histological or cytological confirmation in case of only extrahepatic metastasis not required for inclusion)
    3. By means of whole-body MRI documented disease according to RECIST version 1.1 with at least one unidimensional measurable lesion ≥ 10 mm
    4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, 2
    5. Male or female patients ≥ 18 years of age
    6. Estimated life-expectancy more than 5 months
    7. Hematologic function, as follows:
    Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
    Platelet count ≥ 100 x 109/L
    Hemoglobin ≥ 9 g/dL
    8. Renal function, as follows
    Creatinine ≤ 1.5 x upper limit of normal (ULN)
    9. Hepatic function, as follows
    Aspartate aminotransferase (AST) ≤ 2.5 x ULN (if liver metastases ≤ 5 x ULN)
    Alanine aminotransferase (ALT) ≤ 2.5 x ULN (if liver metastases ≤ 5 x ULN)
    Total bilirubin ≤ 3 mg/dl
    Alkaline phosphatase ≤ 4.0 x ULN
    10. PT-INR/PT < 1.5 x ULN
    11. Females of childbearing potential (FCBP) must have a negative pregnancy test within 7 days of the first application of study treatment
    and
    must agree to use effective contraceptive birth control measures (combined oral contraceptives, hormone-releasing intrauterine contraceptive device, hormonal contraceptive implants, hormonal contraceptive injectables) in combination with barrier birth control measures during the course of the trial
    or be surgically sterile
    A female subject is considered to be of childbearing potential unless she is age ≥ 50 years and naturally amenorrhoeic for ≥ 2 year, or unless she is surgically sterile.
    12. Males must agree to use barrier birth control measures (condomes) during the course of the trial. In addition males must agree to continue to use these barrier birth control measures for at least 3 months after last administration of study medication.
    E.4Principal exclusion criteria
    1. Previous or concurrent tumor other than uveal melanoma with the exception of cervical cancer in situ, adaequately treated basal cell carcinoma, superficial bladder tumors (Ta, Tis, and T1) or any curatively treated tumors > 3 years prior to enrollment
    2. History of cardiac disease: congestive heart failure ≥ New York Heart Association (NYHA) class 2; active coronary artery disease ([CAD], myocardial infarction more than 6 months prior to study entry is allowed), cardiac arrhythmias requiring antiarrhythmic therapy (only beta blockers or digoxin are permitted)
    3. Known HIV infection
    4. Known chronic infection with hepatitis B or C
    5. Active infection requiring systemic antibiotic/antiviral/antifungal treatment or any uncontrolled infection > Grade 2 NCI-CTCAE
    6. Symptomatic brain or meningeal tumors (unless patient is > 6 months from definitive therapy, had a negative imaging study within 4 weeks of study entry and is clinically stable with respect to the tumor at the time of study enrollment)
    7. Patients with seizure disorder requiring medication (such as steroids or antiepileptics)
    8. History of organ allograft
    9. Patients with evidence or history of bleeding diathesis
    10. Thrombotic or embolic events within the last 6 months
    11. Serious non-healing wound, ulcer or fracture
    12. Uncontrolled arterial hypertension with systolic blood pressure >150 mm Hg and/ or diastolic blood pressure > 90 mg Hg despite optimal treatment, determined twice within one week
    13. Pregnant or breast-feeding patients
    14. Marked claustrophobia
    15. Cardiac pacemaker, cochlea implants or other implanted metal devices, residual metal splinters
    16. Known allergy to the used study drug sorafenib or to any of its excipients
    17. Known hypersensitivity to gadolinium based contrast agents
    18. Subject unwilling or unable to comply with study requirements
    19. Substance abuse, medical, psychological or social conditions that may interfere with the patient´s participation in the study or evaluation of the study results
    20. Participation in any clinical study or treatment with an experimental drug or experimental therapy within 28 days prior to study enrollment or during study participation
    21. Patients receiving anticoagulation therapy with warfarin or phenprocoumon
    22. Treatment with any of the following therapies or drugs
    - Any prior palliative chemotherapy, tyrosine kinase inhibitors (TKI´s) or antiangiogenics (prior adjuvant treatment with vaccine or immunotherapy is allowed provided there is documentation of disease progression).
    - Any chemotherapy, hormonal therapy, immunotherapy, targeted therapy or experimental or approved proteins/antibodies within four weeks prior to study enrollment or during study participation.
    - Radiotherapy or brachytherapy within four weeks prior to study enrollment or during study participation except to eye or bone.
    - Hepatic chemoembolization within four weeks prior to study enrollment or during study participation:
    - Major surgery within 4 weeks of study enrollment
    - Autologous bone marrow transplant or stem cell rescue within 4 months of study enrollment
    - Use of biologic response modifiers, such as G-CSF, within 3 week of study enrollment. (G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator; however, they may not be substituted for a required dose reduction.)
    - Patients receiving newly initiated treatment with erythropoietin or dose adjusted treatment with erythropoietin within 8 weeks of study enrollment or during study participation (Patients receiving permanent erythropoietin treatment are permitted provided no dose adjustment was undertaken within 2 months prior to the study or during the study).
    - Any St. John’s wort containing remedy
    - Prior exposure to study drug
    E.5 End points
    E.5.1Primary end point(s)
    PFS under treatment with sorafenib versus treatment with placebo after random assignment to blinded study medication in the randomized subset (tumor assessment according to RECIST version 1.1 criteria)
    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.8.3 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 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 Information not present in EudraCT
    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
    Last Visit Last Patient (LPLV) will be the last follow-up visit of the last patient having received study drug.
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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.1.3Elderly (>=65 years) No
    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 state200
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 200
    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 Decision2011-03-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-03-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-16
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