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    Summary
    EudraCT Number:2008-006022-34
    Sponsor's Protocol Code Number:BAY43-9006/13337
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2008-12-16
    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 ConcernedUK - MHRA
    A.2EudraCT number2008-006022-34
    A.3Full title of the trial
    Randomized phase II study of sorafenib plus bicaluamide vs. placebo plus bicalutamide in castration-resistant asymptomatic or mildly symptomatic metastatic prostate cancer patients who had orchiectomy or are receiving a LHRH analogue
    A.4.1Sponsor's protocol code numberBAY43-9006/13337
    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 SponsorBayer HealthCare AG
    B.1.3.4CountryUnited Kingdom
    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 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 Yes
    D.2.1.1.1Trade name Nexavar
    D.2.1.1.2Name of the Marketing Authorisation holderBayer HealthCare 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated 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 INNsorafenib
    D.3.9.1CAS number 284461-73-0
    D.3.9.2Current sponsor codeBay-43-9006
    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) 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 No
    D.3.11.8Extractive medicinal product No
    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 placeboFilm-coated tablet
    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
    Metastatic Prostate Cancer
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10062904
    E.1.2Term Hormone-refractory prostate cancer
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10036909
    E.1.2Term Prostate cancer metastatic
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this phase II study in castration-resistant metastatic prostate cancer patients who have had orciectomy or are receiving an LHRH analogue is to demonstrate a prolonged progression-fee survival (PFS) in the group treated with sorafenib and bicalutamide in comparison to those treated with placebo and bicalutamide.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare treatment groups with respect to tumor response, disease control rate, time to PSA progression, PSA response rate and time to PSA response, time to next anti-tumor therapy, overall survival, patient reported outcomes (PRO), and further evaluation of the safety and toxicity profile of the combination treatment. Secondary objectives include also an evaluation of population pharmacokinetics and biomarkers, which may relate to sorafenib's pharmacological mechanism of action and to its antitumor activity.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Age ≥ 18 years.
    •Histological or cytological documentation of adenocarcinoma of the prostate
    •Asymptomatic or mildly symptomatic prostate cancer patients (non-opiate-requiring pain)
    •Progression of disease despite castrate levels of testosterone and adequate therapy with LHRH analogues or after orchiectomy, demonstrated by rising PSA in plasma on at least 2 consecutive measurements taken at least 7 days apart. The last measurement must be ≥2 ng/mL
    •Evaluable bone, lymph node (≥2 cm) or soft tissue metastases
    •Ongoing treatment with LHRH analogues unless patient had an orchiectomy
    •Serum plasma testosterone < 50 ng/dl at screening
    •ECOG Performance Status of 0 or 1
    •Life expectancy of at least 12 weeks.
    •Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 14 days prior to the start of the study treatment [All laboratory assessments will be performed by a central laboratory (see separate laboratory manual for full details)]:
    •Hemoglobin ≥ 9.0 g/dl
    •Absolute neutrophil count (ANC) ≥1,500/mm3
    •Platelet count ≥ 100,000/µl
    •Total bilirubin ≤ 1.5 times the upper limit of normal (ULN)
    •ALT and AST ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer)
    •PT-INR/PT <1.5 x ULN. Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists. For patients on warfarin, close monitoring of at least weekly evaluations will be performed until INR is stable based on a measurement before the study treatment was started, as defined by the local standard of care.
    - Patients being anticoagulated for deep vein thrombosis and/or pulmonary embolus occurring within 12 months of the start of treatment are excluded from this trial.
    •Serum creatinine ≤ 1.5 x ULN
    •Men enrolled in this trial must use adequate barrier birth control measures while in the study and for 3 months after the completion of the study.
    •Signed informed consent must be obtained prior to any study specific procedures.
    E.4Principal exclusion criteria
    Excluded medical conditions:

    •History of cardiac disease;
    •congestive heart failure >New York Heart Association (NYHA) class 2
    •active coronary artery disease (myocardial infarction more than 6 months prior to start of study treatment is allowed)
    •cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted)
    •uncontrolled hypertension (defined as blood pressure ≥ 160 mmHg systolic and/or ≥ 90 mmHg diastolic on medication)
    •History of HIV infection or chronic hepatitis B or C
    •Active clinically serious infections (> grade 2 National Cancer Institute - common terminology criteria for adverse event [NCI-CTCAE] version 3.0)
    •Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of start of study treatment and is clinically stable with respect to the tumor at the time of start of study treatment. Also, the patient must not be undergoing acute steroid therapy or taper therapy (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies).
    •Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
    •History of organ allograft
    •Patients with evidence or history of bleeding diathesis
    •Deep vein thrombosis and/or pulmonary embolus within 12 months of the start of study treatment
    •Delayed healing of wounds, ulcers or bone fractures
    •Patients with pre-existing thyroid abnormality whose thyroid function cannot be maintained within the normal range with medication
    •Patients undergoing renal dialysis
    •Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT treated basal cell carcinoma, superficial bladder tumors [Ta, Tis & T1] or any cancer that was curatively treated more than 3 years before the start of study treatment
    •Any condition that is unstable or could jeopardize the safety of the patient and his compliance in the study
    •Patients unable to swallow oral medications. This applies to patients with severe obstruction of upper gastrointestinal tract that requires gavage.
    •Known hypersensitivity to either NEXAVAR®, to the constituents of the placebo tablets used in this study or to the bicalutamide-containing drug
    •Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results

    Excluded therapies and medications, previous and concomitant:

    •Antiandrogen therapy within the last 6 weeks prior to the start of study treatment
    •Prior sorafenib therapy
    •Any prior cytotoxic chemotherapy for advanced disease (patients that had received adjuvant or neoadjuvant chemotherapy are allowed to participate in the trial), or therapy with receptor tyrosine kinase inhibitors
    •Investigational drug therapy not included in this protocol during the study, or which is taken within 4 weeks or 5 half-lives before the start of the study treatment or inadequate recovery from any toxic effects of such therapies
    •Major surgery during the last 4 weeks prior to the start of study treatment
    •Autologous bone marrow transplant or stem cell rescue during the last 4 months prior to the start of study treatment
    •Use of biologic response modifiers, such as granylocyte colony-stimulating factor (G-CSF), within 3 weeks after the start of study treatment. (G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity such as febrile neutropenia when clinically indicated or at the discretion of the investigator. However, they may not be substituted for a required dose reduction.) Patients taking chronic erythropoietin are permitted in the study provided no dose adjustment is undertaken within 2 months prior to the start of study treatment or during the study.
    •There is no clinical information on the effect of CYP3A4 inducers on the pharmacokinetics of sorafenib, but substances that are inducers of CYP3A4 activity (e.g. rifampicin, St. John’s wort, phenytoin, carbamazepine, phenobarbital, and dexamethasone) are expected to increase the metabolism of sorafenib and thus decrease sorafenib plasma concentrations. Also, there are no clinical data evaluating the effect of chronically co-administered CYP3A4 inducers on the efficacy of sorafenib. Since there is a possibility of decreased sorafenib efficacy due to decreased sorafenib concentrations upon chronic co-administration of CYP3A4 inducers, chronic co-administration of CYP3A4 inducers, should be avoided as much as possible.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable in this study is PFS. It will be measured from the date of randomization until the date of radiological or clinical relapse/progression (whichever is earlier), or until death (if death occurs before progression). Patients without tumor progression or death at the time of analysis will be censored at their last date of evaluation.
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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 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 Yes
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    The end of study for regulatory purposes is defined as the date the last patient completes the end of treatment visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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.1.3Elderly (>=65 years) Yes
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 156
    F.4.2.2In the whole clinical trial 250
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will only be withdrawn from study treatment when they progress on drug. They will then continue with normal clinical treatment dependent on the stage of their disease.
    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 Decision2009-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-12-19
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