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    Summary
    EudraCT Number:2013-003650-24
    Sponsor's Protocol Code Number:KCP-330-005
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-01-28
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2013-003650-24
    A.3Full title of the trial
    A Phase II, Open-label Study of Efficacy and Safety of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 (Selinexor) in Patients with Advanced Gynaecologic Malignancies
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II, Open-label Study of Efficacy and Safety of Selinexor in Patients with Advanced Gynaecologic Malignancies
    A.3.2Name or abbreviated title of the trial where available
    SIGN
    A.4.1Sponsor's protocol code numberKCP-330-005
    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 SponsorKaryopharm Therapeutics, Inc.
    B.1.3.4CountryUnited States
    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 supportKaryopharm Therapeutics Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKaryopharmTherapeutics, Inc.
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street Address85 Wells Ave.
    B.5.3.2Town/ cityNewton
    B.5.3.3Post codeMA 02495
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1617-617-658-0557
    B.5.6E-mailsharon@karyopharm.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 nameSelinexor
    D.3.2Product code KPT-330
    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 INNSelinexor
    D.3.9.2Current sponsor codeKPT-330
    D.3.9.3Other descriptive nameSelective Inhibitor of Nuclear Export (SINE)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 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 nameSelinexor
    D.3.2Product code KPT-330
    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 INNSelinexor
    D.3.9.2Current sponsor codeKPT-330
    D.3.9.3Other descriptive nameSelective Inhibitor of Nuclear Export (SINE)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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: 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 nameSelinexor
    D.3.2Product code KPT-330
    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 INNSelinexor
    D.3.9.2Current sponsor codeKPT-330
    D.3.9.3Other descriptive nameSelective Inhibitor of Nuclear Export (SINE)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced Gynaecologic Malignancies
    Cohort A: Ovarian carcinoma
    Cohort B: Endometrial carcinoma
    Cohort C: Cervical carcinoma
    E.1.1.1Medical condition in easily understood language
    Advanced Gynaecologic Malignancies
    Cohort A: Ovarian cancer
    Cohort B: Endometrial cancer
    Cohort C: Cervical cancer
    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 LLT
    E.1.2Classification code 10008231
    E.1.2Term Cervical cancer recurrent
    E.1.2System Organ Class 100000020978
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10014733
    E.1.2Term Endometrial cancer
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10014734
    E.1.2Term Endometrial cancer 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10014736
    E.1.2Term Endometrial cancer recurrent
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10008229
    E.1.2Term Cervical cancer
    E.1.2System Organ Class 100000020977
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10016182
    E.1.2Term Fallopian tube cancer 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10057529
    E.1.2Term Ovarian cancer 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10016180
    E.1.2Term Fallopian tube cancer
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10066697
    E.1.2Term Ovarian cancer recurrent
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10033128
    E.1.2Term Ovarian cancer
    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 the efficacy of Selinexor in patients with advanced or metastatic gynaecological cancers by disease control rate.
    E.2.2Secondary objectives of the trial
    • • To determine the efficacy of Selinexor in patients with advanced or metastatic gynecological cancers by
    o Objective response rate (ORR)
    o Progression-free survival (PFS)
    o Overall Survival (OS), including OS rates at 12 and 24 months
    • To evaluate safety and tolerability of Selinexor in patients with advanced or metastatic gynecological cancers.
    • To evaluate Quality of Life (QoL) for patients with advanced or metastatic gynecological cancers treated with Selinexor

    • Evaluation of biomarkers in a translational study.
    • Selinexor PK parameters in a subset of patients.


    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female patients age ≥ 18 years
    2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
    3. Adequate hematologic function defined as:
    • platelets ≥ 125 x 109/L
    • hemoglobin ≥ 5.59 mmol/L or 9 g/dL
    • ANC ≥ 1.5 x 109/L
    • WBC ≥ 3.0 x 109/L
    Up to 5% deviation is tolerated. Transfusions and growth factors are allowed.
    4. Adequate liver function, defined as adequate hepatic function within 14 days prior to Cycle 1 Day 1: total bilirubin < 2 times the upper limit of normal (ULN) (except patients with Gilbert’s syndrome, who must have a total bilirubin of < 3 times ULN), aspartate aminotransferase (AST) < 2.0 times ULN, and alanine aminotransferase (ALT) < 2.0 times ULN. In the case of known (radiologically and/or biopsy-documented) liver metastasis, AST < 5.0 times ULN and ALT < 5.0 times ULN is acceptable. Up to 10% deviation is acceptable.
    5. Renal function defined as a calculated or measured glomerular filtration rate ≥ 30 mL/min.
    6. The patient has recovered to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.03 (NCI-CTCAE v4.03) from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted therapies, with the exception of alopecia. The exceptions for such effects are allowed lab values of ≤ Grade 2 specified elsewhere in these inclusion criteria.
    7. Life expectancy of at least 12 weeks.
    8. Able to swallow and retain oral medication.
    9. Patients must give written informed consent according to the rules and regulations of the individual participating site.
    10. Negative serum pregnancy test in women of childbearing potential within 14 days of first dose of treatment, and patients of childbearing potential must agree to use effective contraception during treatment up to 3 months from last dose. Fertile male partners must be willing and able to use effective non-hormonal means of contraception (barrier method of contraception in conjunction with spermicidal jelly, or surgical sterilization) during and for at least 6 months post-study treatment.
    11. The patient must be recovered from any prior treatment/major operation. The treatment/major operation must be performed at least 4 weeks prior to start of study drug. Palliative radiotherapy is permitted until one week prior to the start of study drug.
    12. Only incurable patients with histologically or cytologically proven primary tumor and objective documentation of disease progression on prior treatment by computed tomography (CT)/ magnetic resonance imaging (MRI) may be enrolled.
    13. Ovarian, fallopian tube, or peritoneal carcinoma: both platinum refractory* and platinum resistant** patients, who have received ≥1 line of chemotherapy for relapsed disease (i.e., ≥ 2 lines of chemotherapy in total).
    * Platinum refractory is defined as progression during or within 4 weeks of last treatment with a platinum-containing therapy.
    ** Platinum resistant is defined as relapse 4 weeks to < 6 months after a platinum-containing therapy.
    14. Endometrial carcinoma: patients must have received ≥ 1 line of chemotherapy for relapsed or advanced (stage IV, IIIc) disease.
    15. Cervical carcinoma: patients must have received ≥ 1 line of chemotherapy for relapsed or advanced (stage IVb) disease.
    16. Carcinosarcomas (Malignant Mixed Mullerian Tumor) are allowed, but all other non-epithelial cancers of the ovary, fallopian tube, endometrium, or cervix are excluded.
    17. Patients must have either measurable disease (Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1]) or evaluable disease outside irradiated field on CT/MRI. For ovarian cancer: Patients must have disease that is measurable according to RECIST or assessable according to the Gynecologic Cancer Intergroup (GCIG) CA-125 criteria. A rise in CA-125 or other tumor marker alone is not sufficient.
    E.4Principal exclusion criteria
    1. Disease-Specific Exclusions:
    • Evidence of complete or partial bowel obstruction.
    • Need of Total Parenteral Nutrition.
    2. Patients who are pregnant or breast feeding.
    3. Radiation (except planned or on-going palliative radiation to bone outside of the region of measurable disease) ≤ 3 weeks prior to Cycle 1 Day 1.
    4. Chemotherapy, immunotherapy or any other systemic anti-cancer therapy, (including investigational anti-cancer therapy) ≤3 weeks prior to Cycle 1 Day 1.
    5. Diagnosis or recurrence of invasive cancer other than the present cancer within 3 years (except basal or squamous cell carcinoma of the skin that has been definitively treated).
    6. Unstable cardiovascular function:
    o Symptomatic ischemia, or
    o Uncontrolled clinically significant conduction abnormalities (e.g., ventricular tachycardia on anti-arrhythmics are excluded and 1st degree AV block or asymptomatic LAFB/ RBBB will not be excluded), or
    o Congestive heart failure (CHF) of NYHA Class ≥ 3, or myocardial infarction (MI) within 3 months of Cycle 1 Day 1.
    7. Uncontrolled active infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to the first dose. Active infection with concurrent treatment is acceptable only if the patient is clinically stable.
    8. Significantly diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea.
    9. Concurrent therapy with approved or investigational anti-cancer therapeutics.
    10. Medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
    11. Known brain metastases unless adequately treated (surgery or radiotherapy) with no evidence of progression and neurologically stable off anticonvulsants and glucocorticoids.
    12. All non-epithelial cancers of the ovary, fallopian tube, peritoneum, endometrium or cervix as well as neuro-endocrine tumors are excluded.
    E.5 End points
    E.5.1Primary end point(s)
    Disease control rate (complete response, partial response + stable disease for at least 12 weeks, assessed according to RECIST 1.1 criteria)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 6 and 12 weeks of treatment and every 8 weeks thereafter
    E.5.2Secondary end point(s)
    1. Response to therapy per RECIST 1.1: response for patients in each cohort will be determined by the objective response rate (ORR), defined as either CR or PR using RECIST 1.1 calculated as a proportion and including a two-sided 95% CI for that cohort.
    2. Response to therapy per GCIG response criteria (RECIST 1.1 and CA-125): response for patients in the ovarian cohort will also be assessed for DCR and ORR, as described above, using the GCIG response criteria.
    3. Median Progression-free Survival (PFS): PFS for patients in each cohort will be calculated from the date of start of study
    therapy to the date of PD based on RECIST 1.1, or date of death if PD does not occur.
    4. Overall Survival (OS): OS for patients in each cohort will be calculated from the date of start of study therapy to the date of death due to any cause. OS rate at 12 and 24 months will also be calculated.
    5. Safety and tolerability of selinexor will be evaluated descriptively for all study patients combined, according to NCI CTCAE, v.4.03. Safety endpoints include AEs, clinical laboratory data, vital signs, ECGs, and physical examinations, further described below.
    6. Quality of Life (QoL) will be evaluated for patients in each cohort, and for all study patients combined by EORTC QLQ-C30.
    7) Evaluation of biomarkers in a translational study.
    8) Pharmacokinetics in a subset of patients
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) - 3) After 6 and 12 weeks of treatment and every 8 weeks thereafter
    4) throughout the trial and every 3 months in FU
    5) Throughout the treatment phase until 30 days after last dose
    6) After 6 and 12 weeks of treatment and every 8 weeks thereafter as well as End of treatment
    7) Baseline and Day 1 in cycles 1-2
    8) Cycle 1 day 15
    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 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 No
    E.8.1.1Randomised Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 years3
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days5
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days5
    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: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 95
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 95
    F.4.2.2In the whole clinical trial 95
    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)
    After completion of the study at routine follow-up (EOT), patients will generally be treated at the discretion of the investigator according to medical routine.
    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 Decision2014-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-03-22
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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