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    The EU Clinical Trials Register currently displays   44009   clinical trials with a EudraCT protocol, of which   7316   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:2008-004429-41
    Sponsor's Protocol Code Number:BAY43-9006/12007
    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:2008-09-15
    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 number2008-004429-41
    A.3Full title of the trial
    A Double-Blind, Randomized Phase II Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer Patients who have achieved a Complete Clinical Response after Standard Platinum/Taxane Containing Chemotherapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    N/A
    A.4.1Sponsor's protocol code numberBAY43-9006/12007
    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 Healthcare 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 HealthCare AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer HealthCare 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 code13342
    B.5.3.4CountryGermany
    B.5.6E-mailclinical-trials-contact@bayerhealthcare.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 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 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
    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 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
    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
    The study population will include patients with FIGO stage III or IV ovarian cancer or primary peritoneal cancer who have had extensive debulkment surgery and who have achieved a clinical complete response (disappearance of all clinical and radiological evidence of tumor) after one regimen of standard platinum/taxane-based chemotherapy for whom treatment with sorafenib is considered medically acceptable.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10052171
    E.1.2Term Peritoneal carcinoma
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10033164
    E.1.2Term Ovarian epithelial cancer stage IV
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10033163
    E.1.2Term Ovarian epithelial cancer stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this study is to evaluate the efficacy and safety of sorafenib compared to placebo in Ovarian Epithelial Cancer or Primary Peritoneal Cancer patients who have achieved a complete clinical response after standard platinum/taxane containing chemotherapy.

    The primary objective is to compare the treatment groups in terms of progression free survival (PFS) which in this setting is based on time to CT-documented relapse.
    E.2.2Secondary objectives of the trial
    The secondary objectives include the time to first pathologic CA125 serum levels (needs to be confirmed with a second measurement within 2 weeks), the overall survival (OS), the ovarian cancer symptom response, the general health status and the safety.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patients must be able and willing to sign a written informed consent. A signed informed consent must be appropriately obtained prior to any study specific procedures.
    • Age ≥18 years.
    • Histologically confirmed FIGO stage III or IV ovarian epithelial cancer or primary peritoneal cancer at presentation. Patients must have achieved a clinical complete response (disappearance of all clinical and radiological evidence of tumor) after only one regimen (4-8 cycles) of platinum and taxane-based standard chemotherapy received after tumor debulkment. Details for chemotherapy and surgical debulkment are as follows:
    -Standard debulking surgery: Surgery followed by one regimen (4-8 cycles) of platinum and taxane-containing standard chemotherapy received after tumor debulkment.
    -Interval surgical debulkment: Interval debulking will be defined as debulking surgery that is performed after a minimum of 2 cycles of platinum/taxane containing chemotherapy, or after a maximum of 6 cycles of chemotherapy. All patients who undergo interval debulking must subsequently complete at least 2 additional cycles of chemotherapy after debulking, and all must complete the required 4-8 cycles of chemotherapy.
    -There is to be only one debulking procedure per patient.
    -The taxane and platinum compounds used for either intravenous or intraperitoneal treatment can be replaced with another taxane or platinum compound, respectively. Dosing and timing of the treatment cycles (e.g. 3-weekly or 4 weekly) may vary at the discretion of the clinical investigator.
    -Intraperitoneal chemotherapy is not allowed for patients undergoing interval debulking. For patients with optimally debulked residual disease following standard debulking surgery (largest tumor nodule ≤ 1.0 cm), intraperitoneal chemotherapy can be applied.
    -No more than 6 intraperitoneal treatment cycles are allowed.
    -Cross-over from intraperitoneal chemotherapy to standard intravenous taxane/platinum chemotherapy is allowed at any time. However, the total number of treatment cycles, no matter what modality, must not exceed 8.
    -Complete clinical response will be documented via an eligibility scan that is performed after completion of required chemotherapy. No previous chemotherapy can be administered except for the one regimen of IV/IP chemotherapy for ovarian or primary peritoneal cancer.
    • Normal serum CA125 level within 14 days of first dose of the study drug.
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    • All scans used to document complete response must be done within 42 days prior to randomization.
    • Eligibility scan must be completed within 60 days of the date of the last dose of chemotherapy. All scans used to document complete response must be done within 42 days prior randomization
    • Patients must be able to swallow and retain oral medication.
    • 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 randomization:
    - Hemoglobin ≥8.5 g/dl
    - Absolute neutrophil count (ANC) ≥1,500/µl
    - Platelet count ≥ 75,000/µl
    - Total bilirubin ≤ 1.5 times the upper limit of normal
    - Alanine aminotransaminase (ALT) and Aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal
    - Alkaline phosphatase ≤ 4 x upper limit of normal (ULN)
    - Prothrombin time (PT)/international normalized ratio (INR) and partial thromboplastin time (PTT) < 1.5 x ULN
    - Serum creatinine ≤ 1.5 x ULN.
    • Women of childbearing potential must have a negative serum pregnancy test performed within 14 days prior to the start of treatment. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
    • Women of childbearing potential must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation.


    E.4Principal exclusion criteria
    • Patients with any residual cancer tissue after the completion of chemotherapy detectable by standard CT or magnetic resonance imaging (MRI).
    • Prior local radiotherapy, neoadjuvant chemotherapy or hormonal or any other systemic treatment other than that specified in the protocol for any current or prior diagnosis of ovarian or primary peritoneal cancer. Single-agent weekly paclitaxel will not be considered standard for the purpose of this trial, and is therefore excluded.
    • Male sex.
    • Patients with more than one surgical procedure for ovarian or peritoneal cancer. This does not refer to diagnostic biopsies, but does exclude second-look operations.
    • Histologic subtypes of ovarian cancer other than epithelial (i.e. sarcoma, lymphoma, germ cell).
    • Major surgery, open biopsy, or significant traumatic injury within 30 days prior to randomization.
    • Non-healing wound, ulcer, or bone fracture.
    • Evidence or history of bleeding diathesis or coagulopathy.
    • Clinically significant cardiac disease including congestive heart failure > class II New York Heart Association (NYHA), unstable angina (angina symptoms at rest), new-onset angina (begun within the last 3 months) or myocardial infarction within the past 6 months prior to randomization.
    • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg) despite optimal medical management.
    • Thrombotic or embolic venous or arterial events, such as a cerebrovascular accident, including transient ischemic attacks and pulmonary embolism within the past 6 months.
    • Hemorrhage/bleeding event ≥ NCI-Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 within 30 days of randomization.
    • Infection > NCI-CTCAE Grade 2.
    • Known human immunodeficiency virus infection or infection with hepatitis B or C.
    • Previous or concurrent cancer that is distinct in primary site or histology from ovarian or primary peritoneal cancer within 5 years prior to randomization EXCEPT cervical cancer in situ, treated basal cell carcinoma and superficial bladder tumors [Ta (Non invasive tumor), Tis (Carcinoma in situ) and T1 (Tumor invades lamina propria)].
    • Known or suspected allergy to sorafenib or hypersensitivity to sorafenib or any agent given in the course of this trial.
    • Patients with seizure disorder requiring medication (such as steroids or anti-epileptics).
    • Patients undergoing renal dialysis.
    • Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results.
    • Unresolved toxicity (i.e. neurotoxicity) attributed to the required chemotherapy higher than NCI-CTCAE (version 3) Grade 2 (excluding cases of alopecia).
    • Patients unable to swallow oral medications.
    • Any malabsorption condition.
    • Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
    • Known brain metastasis. Patients with unexplained neurological symptoms will undergo a CT scan/MRI of the brain to exclude brain metastasis.
    • Pregnant or breast-feeding patients. Women of childbearing potential must have a negative pregnancy test performed within 14 days of the start of treatment, and must use adequate birth control measures during the course of the trial. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.

    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is Progression-Free Survival (PFS), which is defined as the time from randomization to tumor progression (radiological or clinical, whichever is earlier) or death (for those who die prior to documented progression). Patients alive without documented progression at the time of analysis will be censored at their last date of tumor 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 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) 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 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.8.3 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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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
    Belgium
    Canada
    Finland
    France
    Germany
    Hong Kong
    Italy
    Japan
    Korea, Democratic People's Republic of
    Netherlands
    Poland
    Singapore
    Spain
    United States
    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
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    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: 194
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 52
    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 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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 170
    F.4.2.2In the whole clinical trial 250
    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 Decision2008-10-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-09-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-12-12
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