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    Summary
    EudraCT Number:2017-001050-33
    Sponsor's Protocol Code Number:4SC-202-2-2017
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-06-19
    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 ConcernedGermany - BfArM
    A.2EudraCT number2017-001050-33
    A.3Full title of the trial
    An open-label Phase Ib/ II, multi-center study of 4SC-202 in Combination with Pembrolizumab in Patients with Unresectable Stage III/Metastatic Stage IV Cutaneous Melanoma primary refractory/non-responding to prior Anti-PD-1 Therapy – The SENSITIZE Study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Eine offene, multizentrische Phase Ib/II Studie mit 4SC-202 in Kombination mit Pembrolizumab bei Patienten mit einem Melanom der Haut im nicht-resezierbaren Stadium III oder metastasierten Stadium IV, primär refraktär oder ohne Ansprechen auf eine vorherige Behandlung mit einem Anti-PD-1 Antikörper.
    A.3.2Name or abbreviated title of the trial where available
    SENSITIZE
    A.4.1Sponsor's protocol code number4SC-202-2-2017
    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 Sponsor4SC AG
    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 support4SC AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation4SC AG
    B.5.2Functional name of contact pointBabett Krauss
    B.5.3 Address:
    B.5.3.1Street AddressFraunhoferstr. 22
    B.5.3.2Town/ cityPlanegg-Martinsried
    B.5.3.3Post code82152
    B.5.3.4CountryGermany
    B.5.4Telephone number00498970076324
    B.5.5Fax number00498970076329
    B.5.6E-mailbabett.krauss@4sc.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 name4SC-202
    D.3.2Product code BYK456992
    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 INNDomatinostat
    D.3.9.1CAS number 1186222-89-8
    D.3.9.3Other descriptive name4SC-202
    D.3.9.4EV Substance CodeSUB48521
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 2
    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 Keytruda
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namePembrolizumab
    D.3.4Pharmaceutical form Powder for concentrate for 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 INNPEMBROLIZUMAB
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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.IMP: 3
    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 name4SC-202
    D.3.2Product code BYK456992
    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 INNDomatinostat
    D.3.9.1CAS number 1186222-89-8
    D.3.9.3Other descriptive name4SC-202
    D.3.9.4EV Substance CodeSUB48521
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 4
    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 Keytruda
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namePembrolizumab
    D.3.4Pharmaceutical form Concentrate for 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 INNPEMBROLIZUMAB
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.4EV Substance CodeSUB167136
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Unresectable Stage III/Metastatic Stage IV Cutaneous Melanoma
    E.1.1.1Medical condition in easily understood language
    Melanoma of the skin which cannot be resected or is metastatic
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to determine safety and tolerability of combination treatment with 4SC-202 and Pembrolizumab in patients with advanced cutaneous malignant melanoma who are primary refractory or non-responding to anti-PD-1 therapy
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are to:
    • Examine preliminary efficacy of combination treatment with 4SC-202 and Pembrolizumab
    • Determine non-tolerated dose (NTD), maximum tolerated dose (MTD) and recommended phase 2 dose (RPTD) of combination treatment with 4SC-202 and Pembrolizumab
    • Characterize pharmacokinetics (PK) of 4SC-202
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    All inclusion criteria must be met during screening, unless otherwise stated.
    Signed informed consent must be obtained prior to any study specific procedure.
    1. Male or female patients, age ≥ 18 years (at screening)
    2. ECOG PS 0-1
    3. Patients with unresectable stage III or stage IV cutaneous melanoma, as per AJCC (Version 8) staging system (must have been histologically confirmed at least once during course of disease)
    4. Patients with metastatic tumor of unknown primary site and histology of melanoma are eligible
    5. Patients must be primary refractory or non-responding to anti-PD-1 therapy (either as monotherapy or in combination with Ipilimumab)
    The following definitions apply:
    I. Primary refractory: Patients not achieving a response of CR, PR or SD (i.e. not achieving disease control)
    II. Non-responding: Patients not having achieved a response of CR or PR but having achieved SD
    6. Patients must have progressed during anti-PD-1 mono therapy or Ipilimumab/anti-PD-1 combination therapy, and within 6 months after the last dose of either Nivolumab or Pembrolizumab
    7. Patients must have had anti-PD-1 mono therapy or Ipilimumab/anti-PD-1 combination therapy as the last systemic cancer directed treatment consisting of at least two administrations of either Nivolumab or Pembrolizumab and must have received the last anti-PD-1 administration within 6 months prior to ICF signature
    8. Patients must have been tested for BRAF V600 mutation status
    9. Patients with BRAF-mutated melanoma must have had a BRAF-mutation directed therapy, unless they were not considered eligible (e.g. due to contraindications) to such treatment
    10. Measurable disease by CT or MRI per irRECIST 1.1 criteria, with longest diameter for non-nodal lesions ≥ 10 mm and ≥ 15 mm in short axis for nodal lesions
    11. At least one tumor site (either primary site or metastasis) must be accessible for sequential biopsies and patient must consent to the 2 mandatory biopsies. This requirement is not applicable for continuous dosing schedules and may be waived by the sponsor in other individual cases
    12. Females of Childbearing Potential must agree to use highly effective contraception from screening to at least four months after the last dose of Pembrolizumab or 4SC-202 (whatever is later)
    E.4Principal exclusion criteria
    1. Patients not consenting to use adequate contraception as required per protocol.
    2. Patients currently participating or who have participated in a study of an investigational agent or who are using an investigational device or have done so within 28 days of the first dose of study drug.
    3. Patients who achieved a CR or PR, during or after prior anti-PD-1 mono or anti CTLA-4/anti-PD-1 combination therapy
    4. Life expectancy below 3 months
    5. Patients with uveal or mucosal melanoma
    6. Patients with symptomatic brain metastases/CNS involvement
    7. Patients with inadequate organ function, defined as:
    a) Absolute neutrophil count (ANC) < 1500/µL
    b) Hemoglobin (Hb) < 9 g/dL
    c) Platelet count < 100,000/µL
    d) Potassium outside of normal limits and not correctable with supplements
    e) Serum creatinine > 1.5 x ULN or eGFR < 50 mL/min (as per Cockroft-Gault formula).
    f) ALT and/or AST > 2.5 x ULN .
    g) Serum total bilirubin > 1.5 x ULN.
    h) LDH > 5 x ULN.
    8. Remaining relevant toxicity (excluding alopecia, fatigue) to previous therapy has not resolved to Grade 1 (applicable at screening)
    9. Patients with a history of anti-PD-1 / immune-related adverse drug reactions of Grade 4 or Grade 3 and a high risk of re-occurrence (as judged by the investigator)
    10. Prior treatment with a HDAC or LSD1 inhibitor or both
    11. Prior treatment with anti-PD-L1 or anti-PD-L2 agents (prior treatment with anti-CTLA-4 agents is allowed)
    12. Patients with precedent systemic anti-cancer therapy including chemotherapy, endocrine therapy, immunotherapy or use of other investigational agents prior first study drug administration.
    13. Therapy with agents known to prolong the QT interval and increase the risk for Torsades de Pointes, such as certain antibiotics (i.e. erythromycin, clarithromycin), antidepressants (i.e. doxepin, amitryptilin) or neuroleptics (i.e. haloperidol, clozapin)
    14. Patients who have received a live vaccine within 28 days prior to anticipated first dose of study drug.
    Medical History related:
    15. Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medications (e.g. methotrexate, azathioprine, mTOR inhibitors, Interferons, mycophenolate, anti-TNF agents, and other) within 14 days of study drug administration.
    16. Patients with any immunodeficiency disorder
    17. Patients with any active, known or suspected autoimmune disease that might deteriorate when receiving an immunostimulatory agent as judged by the investigator
    18. Patients with a marked baseline prolongation of QT/QTc interval, e.g., repeated demonstration of a QTc interval >450 msec (Grade 1 NCI-CTCAE); Long-QT-Syndrome (QTcF is applicable)
    19. Patients with any active gastrointestinal disorder that could interfere with the absorption of 4SC-202 (as per judgement of the investigator), such as ulcerative colitis, Crohn’s disease, diabetic gastroparesis, or other syndromes characterized by malabsorption
    20. Patients who are unable to take oral medication
    21. Patients with a history of other malignancies unless having undergone definitive treatment more than 5 years prior to entry into the study and without evidence of recurrent malignant disease. Patients with basal cell carcinoma of the skin; superficial carcinoma of the bladder; carcinoma of the prostate or cervical intraepithelial neoplasia are eligible for the study if the disease has been clinically stable within the previous 3 years and no treatment is required
    22. Patients with any other medical, psychiatric or social condition, which in the opinion of the investigator would preclude participation in the trial, pose an undue medical hazard, interfere with the conduct of the trial or interfere with interpretation of the trial results
    23. Women who are pregnant or lactating or who are planning on becoming pregnant during the trial or for 90 days after completion of the trial
    24. Patients with known HIV, acute or chronic active hepatitis B (defined as positive titers for HBsAg, anti-HBc-IgM or DNA) or Hepatitis C
    25. Patients with an active systemic infection
    26. Patients with major surgery within the last 4 weeks.
    27. Patients with history or current evidence of clinically relevant allergies or hypersensitivity.
    28. Patients with significant current cardiovascular disease including:
    a. Unstable angina pectoris within 6 months prior to screening
    b. Uncontrolled hypertension
    c. Congestive heart failure (New York Heart Association (NYHA) Class III or IV) related to primary cardiac disease
    d. Conditions requiring anti-arrhythmic therapy (patients with status post pace maker implantation can be included)
    e. Symptomatic ischemic or severe valvular heart disease, or a myocardial infarction within 6 months prior to the trial entry
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability of the combination of 4SC-202 and Pembrolizumab will be assessed from adverse events, laboratory tests, vital signs, ECGs, ECOG PS, physical examination and assessment of concomitant medications.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Dose limiting toxicities will be evaluated during the DLT period:
    For dose Levels 1, 2a, 3:
    The DLT period encompasses the first 3 cycles, i.e. the initial 4SC-202 monotherapy cycle (Cycle 1) and the following 2 cycles of 4SC-202 and Pembrolizumab combination treatment (Cycle 2 and 3).
    For dose Levels 2b, 4:
    The DLT period encompasses the first 2 combination therapy cycles, i.e. extends from Cycle 1 Day 1 to Cycle 2 Day 21.
    E.5.2Secondary end point(s)
    Preliminary anti-tumor efficacy of combination treatment with 4SC-202 and Pembrolizumab as response rates and survival will be determined using irRECIST31.
    Anti-tumor efficacy will be assessed by calculating the following parameters:
    • Objective Response Rate (ORR)
    • Best Overall Response (BOR)
    • Disease Control Rate (DCR)
    • Duration of Response (DOR)
    • Progression Free Survival (PFS)
    • Time to Progression (TTP)
    • Overall Survival (OS)
    Pharmacokinetic analysis will be summarized in a separate report which will be included in the CSR.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of each 4th cycle, within ± 7 days of D1 of C5, C9, C13, C17, etc., and in case of suspected PD (as per local practice)
    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 Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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.1.2.1Number of subjects for this age range: 17
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 17
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 34
    F.4.2.2In the whole clinical trial 34
    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)
    Patients who benefit from the treatment at the end of the treatment period will be provided with 4SC-202 after the study on an individual basis.
    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 Decision2017-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-17
    P. End of Trial
    P.End of Trial StatusOngoing
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