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    Summary
    EudraCT Number:2011-004396-36
    Sponsor's Protocol Code Number:16037
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-07-05
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2011-004396-36
    A.3Full title of the trial
    Phase III randomized sequential open-label study to evaluate the efficacy and safety of sorafenib followed by pazopanib versus pazopanib followed by sorafenib in the treatment of advanced / metastatic renal cell carcinoma (SWITCH 2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the efficacy and safety of sorafenib followed by pazopanib compared to the treatment setting pazopanib followed by sorafenib in the treatment of advanced /metastatic renal cancer
    A.3.2Name or abbreviated title of the trial where available
    SWITCH 2
    A.4.1Sponsor's protocol code number16037
    A.5.4Other Identifiers
    Name:AUO study code numberNumber:An 33/11
    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 SponsorFakultät für Medizin der Technischen Universität München
    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 supportFakultät für Medizin der Technischen Universität München
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSMS-oncology
    B.5.2Functional name of contact pointClinical Research Organisation
    B.5.3 Address:
    B.5.3.1Street AddressScience Park 408
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1098 XH
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+31204350580
    B.5.5Fax number+31204350589
    B.5.6E-maile.bettenhaussen@sms-oncology.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 Yes
    D.2.1.1.1Trade name Nexavar
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/04/207
    D.3 Description of the IMP
    D.3.1Product nameNexavar
    D.3.4Pharmaceutical form Film-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 INNSORAFENIB TOSILATE
    D.3.9.1CAS number 475207-59-1
    D.3.9.3Other descriptive nameSorafenib
    D.3.9.4EV Substance CodeSUB22347
    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) 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 Votrient 200 mg
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 nameVotrient
    D.3.4Pharmaceutical form Film-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 INNPAZOPANIB HYDROCHLORIDE
    D.3.9.1CAS number 635702-64-6
    D.3.9.3Other descriptive namePazopanib
    D.3.9.4EV Substance CodeSUB31270
    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) 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 Yes
    D.2.1.1.1Trade name Votrient 400 mg
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 nameVotrient
    D.3.4Pharmaceutical form Film-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 INNPAZOPANIB HYDROCHLORIDE
    D.3.9.1CAS number 635702-64-6
    D.3.9.3Other descriptive namePazopanib
    D.3.9.4EV Substance CodeSUB31270
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 / metastatic renal cell carcinoma
    E.1.1.1Medical condition in easily understood language
    Advanced / metastatic renal cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10038410
    E.1.2Term Renal cell carcinoma 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 19.0
    E.1.2Level PT
    E.1.2Classification code 10050513
    E.1.2Term Metastatic renal cell carcinoma
    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 if progression -free survival from randomization to progression or death during second -line therapy (total PFS) of sorafenib followed by pazopanib ist non-inferior compared to pazopanib followed by sorafenib
    E.2.2Secondary objectives of the trial
    1. Time from randomization to progression during second-line therapy (total TTP)
    2. Time to first-line treatment failure (progression, death, discontinuation due to toxicity) descriptively in each arm.
    3. PFS in first-line and second-line treatment, descriptively
    4. Overall survival, descriptively (data cut-off same as for primary endpoint)
    5. Disease Control Rate (DCR); Response rates in first-line and in second-line (CR, PR, SD according to RECIST criteria)
    6. Health-related Quality of Life (FACT-F, FKSI-10)
    7. Safety and tolerability


    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Explorative biomarker programms:
    1. Circulating Tumor Cells
    2. Single Nucleotide Polymorphisms
    3. Serum Protein Signatures
    4. C-reactive protein as prognostic marker
    E.3Principal inclusion criteria
    1. Patients with metastatic / advanced RCC (all histologies), who are not suitable
    for cytokine therapy and for whom study medication constitutes first-line
    treatment. For cytokine-unsuitability at least one of the following criteria must be
    fulfilled*:
     Age 66 to 88 years
     Non-clear cell histology RCC
     Intermediate risk according to MSKCC score
     ECOG ≥ 1 and> 1 organ metastasis + < 24 months between diagnosis and
    establishing indication for interleukin-2-therapy
    - ECOG ≥ 1 and „unable to carry on normal activity or do active work“
    (Karnofsky Index 70%)
    - Creatinine ≥ 1x ULN and < 2x ULN
    - Total bilirubin ≥ 1x ULN and < 1.5x ULN
    - Present autoimmune disease
    - Patients who might require steroids
    - Hypersensitivity against cytokines
    - Severe organic disease, not interfering with other in-/exclusion criteria of the
    Switch-2 study
    - Non-symptomatic brain metastases
    - Severe lung disease (e.g. PAH, COPD) with Pa O2 < 60 mmHg on rest
    2. Age ≥ 18 and ≤ 85 years
    3. Karnofsky Index ≥ 70% (see appendix “15.1 Performance Status (ECOG,
    Karnofsky)”)
    4. MSKCC prognostic score (2004), low or intermediate (see appendix “15.2
    Motzer Scoring”)
    5. Life expectancy of at least 12 weeks
    6. Subjects with at least one uni-dimensional (for RECIST 1.1, see appendix “15.3
    RECIST 1.1) measurable lesion. Lesions must be measured by CT/MRI-scan
    7. Adequate bone marrow, liver and renal function as assessed by the following
    laboratory requirements to be conducted within 7 days prior to start of therapy:
    - Hemoglobin > 9.0 g/dl
    - Absolute neutrophil count (ANC) >1,500/μl
    - Platelet count  100,000/μl
    - Total bilirubin < 1.5x the upper limit of normal (Note: Subjects with Gilbert’s
    Syndrome are eligible if their total bilirubin is <3.0 X ULN and direct bilirubin
    is ≤ 35%.)
    - ALAT and ASAT < 2.5x upper limit of normal (Note: concomitant elevations in
    bilirubin and ASAT/ALAT above 1.0x upper limit of normal are not permitted).
    - Alkaline phosphatase < 4x upper limit of normal
    - PT-INR/aPTT < 1.2x upper limit of normal [Patients who are being
    therapeutically anticoagulated with an agent such as coumadin or heparin will
    be allowed to participate provided that their INR is stable and within the
    recommended range for the desired level of anticoagulation and no prior
    evidence of underlying abnormality in these parameters exists.]
    - Serum creatinine < 2 x upper limit of normal
    8. Written Informed Consent
    _____________________________________________________________________
    *Based on references:
    o Kirchner H., H. Heinzer, J. Roigas und F. Overkamp: Differentialtherapie beim
    metastasierenden Nierenzellkarzinom. Der Onkologe 2008; 14: 191-197;
    o SmPC of interleukin-2
    o SmPC of interferon alfa -2a
    E.4Principal exclusion criteria
    1. History of cardiac disease: congestive heart failure >NYHA class 2 or with LVEF at
    baseline echocardiography < 50% (echocardiography is optional); active CAD (MI
    more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring
    anti-arrhythmic therapy (beta blockers or digoxin are permitted)
    2. Uncontrolled hypertension (defined as blood pressure ≥ 150 mmHg systolic and/or
    ≥ 90 mmHg diastolic on medication).
    3. History of HIV infection or chronic hepatitis B or C
    4. Active clinically serious infections (> grade 2 NCI-CTC version 4.03)
    5. Symptomatic metastatic brain or meningeal tumors (unless the patient is > 6
    months from definitive therapy, has a negative imaging study within 4 weeks of
    study entry and is clinically stable with respect to the tumor at the time of study
    entry)
    6. Patients with seizure disorder requiring medication (such as steroids or antiepileptics)
    7. Patients with evidence or history of bleeding diathesis
    8. History of organ allograft
    9. Major surgery within 4 weeks of start of study
    10. Autologous bone marrow transplant or stem cell rescue within 4 months before
    study start.
    11. Any significant condition that increases the risk for bleeding, including, but not
    limited to active peptic ulcer disease, inflammatory bowel disease, known
    intraluminal or endobronchial metastatic lesions and/or lesions infiltrating major
    pulmonary vessels with risk of bleeding, presence of non-healing wound or trauma
    within 4 weeks prior to first dose of investigational drug
    12. History of cerebrovascular accident including transient ischemic attack (TIA),
    pulmonary embolism or untreated deep vein thrombosis (DVT) within the past 6
    months (Note: Subjects with recent DVT who have been treated with therapeutic
    anti-coagulating agents for at least 6 weeks are eligible)
    13. Corrected QT Interval (QTc) > 480 msecs
    14. Untreated hypothyroidism
    15. Patients undergoing renal dialysis
    16. Previous or concurrent cancer that is distinct in primary site or histology from the
    cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated
    basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer
    curatively treated > 3 years prior to study entry
    17. Pregnant or breast-feeding patients. Women of childbearing potential must have a
    negative pregnancy test performed within 7 days of the start of treatment. Both
    men and women enrolled in this trial must use adequate barrier birth control
    measures (with a Pearl Index < 1) during the course of the trial and 3 months after
    the completion of trial.
    18. Substance abuse, medical, psychological or social conditions that may interfere
    with the patient’s participation in the study or evaluation of the study results
    19. Any condition that is unstable or could jeopardize the safety of the patient and their
    compliance in the study
    20. Patients unable to swallow oral medications
    21. Clinically significant gastrointestinal abnormalities that may affect absorption of
    investigational product
    22. Known allergy to Votrient® or Nexavar®(i.e. to active substance or one of the
    constituents)
    23. Prior exposure to study drugs.
    24. Investigational drug therapy within 4 weeks of study entry.
    25. Use of biologic response modifiers, such as G-CSF and other hematopoietic
    growth factors, within 3 weeks of study entry.
    26. Radiotherapy within 3 weeks of start of study drug and planned radiotherapy
    during the study
    27. Concomitant medication: Any condition at the discretion of the investigator that
    precludes compliance with concomitant therapy restrictions described below:
    Non-permitted medication:
    a. Other anticancer chemo-, cytokine- or targeted therapy for RCC, as well as
    other investigational drug therapy.
    b. Any St. John´s wort containing remedy
    a. Co-administration of pazopanib with medicines that increase gastric pH should
    be avoided.
    - Proton-pump inhibitor (PPI), H2-receptor antagonist, Short-acting antacids
    b. Anticoagulants: Pazopanib should be used with caution in subjects with
    increased risk of severe bleeding or who are receiving concomitant
    anticoagulant therapy
    c. Hypoglycemic therapy including insulin: Transient decreases in serum glucose may require an adjustment in the dose of
    hypoglycemic and/or insulin therapy.
    d. Simvastatin: Concomitant use of pazopanib and simvastatin increases the risk
    of ALT elevations and should be undertaken with caution and close monitoring.
    e. Strong CYP3A4 inhibitors* (e.g. grapefruit juice, star fruit or star fruit juice,
    Seville orange, antibiotics, protease inhibitors, antifungals, antidepressants)
    should be avoided during pazopanib treatment.
    f. CYP3A4 inducers* should be avoided during pazopanib treatment, unless use of
    the drug is essential and no substitute is available.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate if progression -free survival from randomization to progression or death during second -line therapy (total PFS) of sorafenib followed by pazopanib ist non-inferior compared to pazopanib followed by sorafenib
    E.5.1.1Timepoint(s) of evaluation of this end point
    No interim analyses are planned.
    The final analyses will take place once all patients have terminated trial therapy. This is planned for Q4 2016.
    E.5.2Secondary end point(s)
    1. Time from randomization to progression during second-line therapy (total TTP)
    2. Time to first-line treatment failure (progression, death, discontinuation due to toxicity) descriptively in each arm.
    3. PFS in first-line and second-line treatment, descriptively
    4. Overall survival, descriptively (data cut-off same as for primary endpoint)
    5. Disease Control Rate (DCR); Response rates in first-line and in second-line (CR, PR, SD according to RECIST criteria)
    6. Health-related Quality of Life (FACT-F, FKSI-10)
    7. Safety and tolerability


    E.5.2.1Timepoint(s) of evaluation of this end point
    No interim analyses are planned.
    The final analyses will take place once all patients have terminated trial therapy. This is planned for Q4 2016.
    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 Yes
    E.6.13.1Other scope of the trial description
    Explorative biomarker programms:
    1. Circulating Tumor Cells
    2. Single Nucleotide Polymorphisms
    3. Serum Protein Signatures
    4. C-reactive protein as prognostic marker

    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3.1Comparator description
    Sequential application of two study medications (Sorafenib->Pazopanib vs. Pazopanib->Sorafenib)
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA85
    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
    Data collection will be stopped after the end of safety follow-up (LPLV – 31st October 2016) and clean data for the patients exist. After that the trial is terminated.

    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months5
    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: 377
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 377
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 377
    F.4.2.2In the whole clinical trial 377
    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 the subject has ended his/her participation in the trial the investigators will offer appropriate treatment options according to current knowledge and treatment standards.
    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 Arbeitsgemeinschaft Urologische Onkologie (AUO) der Deutschen Krebsgesellschaft e.V.
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-07-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-10-19
    P. End of Trial
    P.End of Trial StatusCompleted
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