Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   35891   clinical trials with a EudraCT protocol, of which   5892   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2010-018501-10
    Sponsor's Protocol Code Number:BAY43-9006/12444
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-01-05
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2010-018501-10
    A.3Full title of the trial
    A Phase III Randomized, Double blind, Placebo-controlled Trial Comparing Capecitabine Plus Sorafenib Versus Capecitabine Plus Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase III Trial Comparing Capecitabine in Combination with Sorafenib or Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer
    A.3.2Name or abbreviated title of the trial where available
    RESILIENCE
    A.4.1Sponsor's protocol code numberBAY43-9006/12444
    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 SponsorBayer 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 supportBayer AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer AG
    B.5.2Functional name of contact pointBayer Clin. Trials Contact CTP Team
    B.5.3 Address:
    B.5.3.1Street AddressBayer Pharma AG, S102, Level 2, Room 156
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post codeD-13342
    B.5.3.4CountryGermany
    B.5.6E-mailctp_germany@bayer.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 Schering Pharma
    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 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.3.9.2Current sponsor codeBAY 43-9006
    D.3.9.3Other descriptive nameSorafenib
    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 RoleComparator
    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 Xeloda
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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 nameXeloda - 150 mg
    D.3.2Product code -
    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 INNCAPECITABINE
    D.3.9.1CAS number 154361-50-9
    D.3.9.3Other descriptive nameCapecitabine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 RoleComparator
    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 Xeloda
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration 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 nameXeloda - 500 mg
    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 INNCAPECITABINE
    D.3.9.1CAS number 154361-50-9
    D.3.9.3Other descriptive nameCapecitabine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Locally advanced or metastatic HER2-negative breast cancer.
    E.1.1.1Medical condition in easily understood language
    For treatment of locally advanced or metastatic breast cancer HER2-negative patients who are resistant to/failed prior taxane and anthracycline or where anthracycline therapy is not indicated.
    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 LLT
    E.1.2Classification code 10004244
    E.1.2Term Benign breast neoplasm NOS
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this phase-III trial is to compare the efficacy and safety of sorafenib in combination with capecitabine versus capecitabine in combination with placebo in the treatment of subjects with locally advanced or metastatic HER2-negative breast cancer who are resistant to or have failed prior taxane and an anthracycline or for whom further anthracycline therapy is not indicated.
    The primary efficacy endpoint is progression-free survival (PFS).
    E.2.2Secondary objectives of the trial
    Secondary efficacy endpoints are overall survival (OS), time to progression (TTP), overall response rate (ORR) and duration of response (DoR). Patient reported outcomes (PROs) include an evaluation of breast cancer symptoms using the Functional Assessment of Cancer Therapy-Breast Symptom Index (8 item) (FBSI-8) questionnaire and health-related quality of life (HRQoL) using the EuroQoL 5 Dimension Questionnaire.
    Safety evaluations comprise adverse event reporting and assessment of laboratory abnormalities.
    In addition, this trial includes an exploratory analysis of biomarkers and estimation of capecitabine, 5-FU, and sorafenib exposures.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Age is ≥18 years.
    •Life expectancy is at least 12 weeks (3 months).
    •Subject has histologically or cytologically confirmed HER2-negative adenocarcinoma of the breast. HER2 status should be determined by an accredited laboratory by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), or chromogenic in situ hybridization (CISH). Note: local accreditation is acceptable.
    •Subject has locally advanced or metastatic disease; locally advanced disease must not be amenable to resection with curative intent (Stage IIIb or IIIc; American Joint Committee on Cancer [AJCC] Staging System, Sixth Edition).
    •Subject has measurable or non-measurable (but radiologically evaluable) disease (according to RECIST 1.1).
    •All computer tomography [CT] [with contrast] and magnetic resonance imaging [MRI]) used to document disease must have been done ≤ 4 weeks before randomization. Bone scans (if clinically indicated) must be done ≤ 12 weeks prior to randomization.
    •Subject must have received up to two prior chemotherapy regimens (adjuvant/neo adjuvant treatments are considered one regimen), and no more than one prior regimen for advanced and/or metastatic disease. Chemotherapy regimens include both targeted and biologic therapy.
    •Prior regimens must have included an anthracycline (eg, doxorubicin, epirubicin) and a taxane (eg, paclitaxel, docetaxel), either in combination or in separate regimens, in either the neo-adjuvant/adjuvant or the metastatic setting or both, as either monotherapy or as part of a combination with another agent. Sequential regimens will count as a single regimen; multiple neo-adjuvant / adjuvant regimens will count as a single regimen.
    •Subject must meet at least one of the following scenarios to be eligible for the study (see Appendix 14.19 in the protocol for definitions of treatment resistance and failure):
    -Resistant to or have failed prior taxane and anthracycline
    OR
    -Resistant to or have failed prior taxane AND for whom further anthracycline therapy is not indicated (eg, intolerance or cumulative doses of doxorubicin or doxorubicin equivalents [eg, epirubicin]).
    NOTE: No minimum dose of prior anthracycline or anthracycline equivalents is required.
    •Subjects who relapse beyond 12 months after the last taxane or anthracycline dose given in the adjuvant, neo-adjuvant, or metastatic setting are eligible. Further therapy with the agent(s) for a subsequent regimen must have been considered and ruled out for example due to: prior toxicity, intolerance, or local standard of practice (see Appendix 14.19 in the protocol for definitions of treatment intolerance).
    •Single agent experimental (not approved) chemotherapy is not allowed. Prior experimental chemotherapy treatment is allowed, provided it is given in combination with at least one drug approved for the treatment of breast cancer (excluding drugs that target VEGF or VEGFR, eg, bevacizumab, brivanib, sunitinib, vatalinib).
    •Subject must have discontinued prior chemotherapy, including both targeted and biologic therapies, prior therapeutic radiation therapy, or prior hormonal therapy for locally advanced or metastatic disease ≥ 4 weeks (28 days) before randomization. Start of study treatment is allowed within less than 28 days of the prior therapy provided that 5 half-lives of the prior treatment drug(s) have elapsed before randomization. Previously radiated areas must not be the only site of disease, unless the site had subsequent evidence of progression. Palliative radiation to bone metastasis for pain control is permitted with provisions (see Section 6.9).
    •ECOG performance status 0 or 1 (see Appendix 14.1 in the protocol).
    •Adequate bone marrow, liver, and renal function within 7 days prior to randomization as assessed by:
    -Hemoglobin (Hgb) ≥ 9 g/dL (transfusion and growth factor independent).
    -Prothrombin time (PT), prothrombin time-international normalized ratio (PT-INR) ≤ 1.5 X ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 X ULN.
    -Prophylactic anticoagulation as described below is permitted:
    - Low dose warfarin (1 mg orally [PO], once daily [QD]) with PT-INR ≤ 1.5 x ULN. For subjects receiving prophylactic doses of warfarin, the PT-INR should be measured prior to initiation of trial drugs (sorafenib/placebo and capecitabine) and should be monitored at least weekly, or as defined by the local standard of care, until it is stable.
    - Low-dose aspirin (≤ 100 mg daily).
    - Prophylactic doses of heparin/heparinoids.
    E.4Principal exclusion criteria
    •HER2-positive breast cancer (IHC ≥ 3+, positive FISH, or positive CISH); equivocal or unknown HER2 status. Subjects with equivocal HER2 status may consent to having their HER2 status retested prior to enrollment by an accredited laboratory.
    •Unknown hormone receptor status (estrogen and progesterone receptor).
    •No prior taxane and anthracycline for the treatment of breast cancer (either in adjuvant, neo-adjuvant or metastatic setting).
    •Bilateral breast cancer or a history of two distinct breast cancers are excluded.
    •Inflammatory breast carcinoma are excluded.
    •Subject must NOT have
    oactive or clinically significant cardiac disease.
    othrombotic, embolic, venous, or arterial events within 6 months before randomization.
    oany hemorrhage/bleeding event of NCI-CTCAE v4.0 Grade 3 or above within 4 weeks before randomization.
    •Radiation to any lesions < 4 weeks prior to randomization. Palliative radiation to bone metastasis for pain control is permitted with provisions.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable will be progression free survival, measured from the date of randomization to the date of first observed disease progression (radiological assessment according to RECIST 1.1 criteria for progression of non-measurable and measurable disease) or the date of death due to any cause (if death occurs before disease progression).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary efficacy endpoint is Progression Free Survival (PFS)

    The objective of this phase-III trial is to compare the efficacy and safety of sorafenib in combination with capecitabine versus capecitabine in combination with placebo in the treatment of subjects with locally advanced or metastatic HER2-negative breast cancer who are resistant to or have failed prior taxane and an anthracycline or for whom further anthracycline therapy is not indicated
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints are OS, TTP, ORR and duration of response (DoR).

    Patient reported outcomes (PRO) include an evaluation of breast cancer symptoms using the Functional Assessment of Cancer Therapy-Breast Symptom Index (8 item) (FBSI-8) questionnaire and health-related quality of life (HRQoL) using the EuroQoL 5 Dimension Questionnaire (EQ-5D).
    • Safety evaluations comprise adverse event reporting and assessment of laboratory abnormalities.
    • In addition, this trial includes an exploratory analysis of biomarkers and estimation of capecitabine, 5-FU, and sorafenib exposures.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For each participating country in the European Union (EU), the end of the trial according to the EU Clinical Trial Directive will be reached when the last visit (ie, end-of-treatment visit) for the last subject for all centers in the respective country has occurred.
    Main analysis of the study will be performed when approximately 363 PFS events are observed. A second analysis will be done when approximately 405 deaths are observed.
    The end of the study will be when the last visit (ie, end of treatment visit) of the last patient (EU and non-EU) is achieved.
    The primary completion date for this study according to the FDA Amendment Act is specified in a separate document (not part of this clinical trial protocol).
    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 No
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA100
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Chile
    China
    Czech Republic
    France
    Germany
    Greece
    Ireland
    Israel
    Italy
    Japan
    Peru
    Poland
    Russian Federation
    South Africa
    Spain
    Sweden
    United Kingdom
    United States
    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
    For each participating EU country, the end of the trial according to the EU Clinical Trial Directive will be reached when the last visit (ie, end-of-treatment visit) for the last subject for all centers in the respective country has occurred.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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: 260
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 259
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 519
    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)
    Subjects who end treatment but do not have progressive disease, should enter Active Assessment Follow-up Period. For such subjects, CT scans/MRIs should be obtained, every 6 wks from the day of randomization through the first 36 wks of trial participation, and then every 9 wks thereafter until documented disease progression occurs and/or anti-tumor treatment is administered. After ending treatment, subjects will enter Long-term Follow-up Period to be contacted for their survival status.
    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 Decision2011-03-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA