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    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   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).

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    Summary
    EudraCT Number:2005-004378-25
    Sponsor's Protocol Code Number:PC SOR-101
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2005-12-29
    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 number2005-004378-25
    A.3Full title of the trial
    A randomized, double-blinded, multicentric phase II trial to optimize the treatment of the hormon refractory prostatic carcinoma in patients without preceding chemotherapy with Sorafenib + Docetaxel + Prednison vs. Placebo + Docetaxel + Prednison
    A.3.2Name or abbreviated title of the trial where available
    A placebo controlled, randomized phase II trial with BAY 43-9006 (Sorafenib)
    A.4.1Sponsor's protocol code numberPC SOR-101
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUrologische Klinik und Poliklinik, Klinikum Großhadern der LMU 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSorafenib
    D.3.2Product code BAY 43-9006
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN4-{4-[3-(4-Chloro-3-trifluoromethyl-phenyl) -ureido]-phenoxy}-pyridine-2-carboxylic acid methylamide-4-methylbenzenesulfonate
    D.3.9.2Current sponsor codeBAY 43-9006
    D.3.9.3Other descriptive nameSorafenib
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2 tabl. a 200 mg/ to b.i.d. (2x400 mg)
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 Information not present in EudraCT
    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 nameTaxotere
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INN(2R,3S)-N-(tert-Butoxycarbonyl)-2-hydroxy-3-phenyl-β-alanin-4-acetoxy-2α-benzyloxy-5β,20-epoxy-1,7β,10β-trihydroxy-9-oxo-11-taxen-13α-ylester
    D.3.9.3Other descriptive nameDocetaxel 20 mg
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration numberper cycle=21 days to 1 dose = 75 mg/m2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.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 Information not present in EudraCT
    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 nameTaxotere
    D.3.4Pharmaceutical form Intravenous infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INN(2R,3S)-N-(tert-Butoxycarbonyl)-2-hydroxy-3-phenyl-β-alanin-4-acetoxy-2α-benzyloxy-5β,20-epoxy-1,7β,10β-trihydroxy-9-oxo-11-taxen-13α-ylester
    D.3.9.3Other descriptive nameDocetaxel 80 mg
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration numberper cycle=21 days to 1 dose = 75 mg/m2
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the 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 progressed and / or metastasized hormon refractory prostate carcinoma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Classification code 10001203
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary efficacy objective of the trial is the comparison of Sorafenib vs Placebo in combination with Docetaxel regarding a progression free survival which is measured by the bio-indicator cPSA in the blood serum (prostate-specific antigen). In terms of the clinical laboratory examination a progress is defined by an increase of the cPSA-level of ≥ 50%.This increase must be approved after two weeks.
    E.2.2Secondary objectives of the trial
    Comparison of the disease control rates (CR+PR+SD)
    Comparison of the overall survival times
    Comparison of the Time to Progression
    Comparison of response rates measured by cPSA
    Comparison of response rates measured by RECIST
    Comparison of progression free survival measured by RECIST
    Comparison of the tolerance profiles in both treatment groups
    PSA response period in both treatment groups
    Comparison of the overall response between both treatment groups
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Main inclusion criteria

    - Histologically or cytologically confirmed adenocarcinoma of the prostate
    - Metastasized adenocarcinoma of the prostate that is hormonrefractory, this means no more response to
    hormon therapy, measured by a continous increase of Serum-PSA levels under preceded therapy
    - Documented progression under the lastly aplied therapy (a definite increase of >20% that is confirmed by
    two successive measurements with a time-lag of at least two weeks, or a 25% increase of measurable
    lesions that are verified by radiologic examinations)
    - Male patients > 18 years of age
    - Preceded hormon therapy
    - ECOG Performance Status ≤ 1
    - An adequate hematologic, renal, cardial and hepatic function according to the following parameters:

    - Neutrophil count ≥ 1500/mm3
    - Thrombocytes ≥ 100.000 mm/3
    - Hemoglobine ≥ 9 g/dl (6,2 mmol/l)
    - Creatinine ≤ 1,5 x of the upper limit of the normal range (ULN), oder Creatinine Plasma-Clearance ≥ 45 ml/min
    - Total bilirubin ≤ 1,5 x ULN
    - AST (SGOT) and ALT (SGPT) ≤ 2,5 x ULN
    - Alcalic Phosphatase ≤ 5 x ULN
    - Amylase und Lipase < 1,5 x ULN
    - PT or INR and PTT < 1,5 x ULN
    - Life expectancy ≥ 12 weeks
    - adequate methods of contraception of the male until three months
    after the discontinuation of the Sorafenib therapy
    - written informed consent and the right to discontinue the trial at any time without any consequences


    E.4Principal exclusion criteria
    Main exclusion criteria

    - Acquainted disorders of the calcium metabolism
    - Curatively treated superficial TCC ≥ 2 years without recidive
    - Previous or recent neoplasies except for curatively treated in situ carcinomata and basal cell carcinomata of
    the skin as well as curatively treated malignomata with no recurrence within the last 5 years
    - Patients with brain tumors or metastases
    - Existent peripheric neutropathies Grade 2
    - Chronical diarrhoeas (now or in the anamnesis)
    - Other severe concomitant diseases:

    a) Patients with congestive heart insufficency; active angina pectoris or ischemia; myocardial infarctions
    within 6 months prior to the trial initiation or patientes with severe cardial arrhythmias that require an
    antiarrhythmic therapy (beta blockrs and digoxine are permitted)
    b) Patients with uncontrolled blood pressure; systolic RR > 150 mm Hg or diastolic pressure > 90 mm Hg
    despite optimal medical treatment
    c) Patients with thrombotic or embolic events like apoplexia or lung embolia
    d) Patients with recent or wellknown hemorrhagic diathesis
    e) Wellknown significant neurological or psychiatrical disorders including dementia and epileptic seizures
    f) Patients with severe infections (>Grade 2 NCI-CTC Version 3.0)
    g) Ulcerations, unstable diabetes mellitus or other contraindications concerning the aplication of highly
    dosed corticosteriods
    h) Untreated vena-cava-syndrome
    i) Wellknown ascites or pericard effusion
    j) Wellknown symptomatic pleural effusion that has to be punctured
    k) Infection with HIV or chronical Hepatits B or C
    - Missing attendance or incapacity to observe the measures of treatment and examination
    - Lack of compliance
    Inadmissible therapies or drugs before or during the treatment with the study medication:
    - Chemo- or Immunotherapy prior to the trial start
    - Simultaneous treatment with additional antitumor therapies (such as
    chemotherapy, immunotherapy, signal transduction inhibitors or hormone therapy)
    except for bisphosphonates and LHRH antagonists in a constant dosage (at least
    since four weeks prior to trial beginning) whereas this therapy should be continued
    then
    - Former treatment with experimental or approved angiogenesis inhibitors
    - Radiation therapy during three weeks prior to the trial start
    - Preceded radiation therapy if over 25% of the bone marrow were affected
    - Major surgery, open biopsies or sigificant traumata during the last four weeks prior
    to the trial start
    - Severe wound healing disorders, ulcera or bone fractures during
    the last four weeks prior to the trial start
    - Patients with organ transplantations during the last four months prior to the trial start
    - Preceded application of substances that target the ras – signal ways or EGFR
    - “Biologic response modifiers” e.g. G-CSF or GM-CSF within three weeks prior to the
    trial start ( G-CSF and other hematopoetic growth factors are only to be applied for
    the management of acute toxicities e.g. neutropenic fever if they are medically
    indicated or according to the discretionary authority of the trial investigator)
    - Participation in other clinical trials within 30 days prior to the therapy start
    - Treatment with rifampicine or saint-john’s-wort (hypericum) during the trial
    - Therapy with digitalis-glycosides or thiacid-diuretics
    E.5 End points
    E.5.1Primary end point(s)
    TTP
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Docetaxel + Placebo
    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.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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
    -----
    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 months0
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state80
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 80
    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)
    The treatment after the subject has ended the participation in the trial will be in a follow-up with the "Best Supportive Care".
    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 Decision2005-12-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-12-05
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-05-11
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