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    Summary
    EudraCT Number:2008-005025-11
    Sponsor's Protocol Code Number:BAY43-9006/13162
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-11-27
    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 number2008-005025-11
    A.3Full title of the trial
    A Phase 2b, Double Blind, Randomized Study Evaluating the Efficacy and Safety of Sorafenib Compared With Placebo When Administered in Combination With Chemotherapy (Modified FOLFOX6) for the Treatment of Metastatic Colorectal Cancer in Subjects Who Have Not Been Previously Treated for Stage IV Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II study comparing sorafenib to placebo when administered in combination with chemotherapy for the treatment of metastatic colorectal cancer in Subjects Who Have Not Been Previously Treated for Stage IV Disease.
    A.4.1Sponsor's protocol code numberBAY43-9006/13162
    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, D-51368 Leverkusen, Germany
    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 supportBayerHealthCare 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 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 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 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 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.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 patient population includes patients with Stage IV metastatic colorectal cancer (mCRC), with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Patients must have measurable disease and must not have received prior systemic anticancer therapy for mCRC.
    E.1.1.1Medical condition in easily understood language
    Metastatic colorectal cancer.
    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 PT
    E.1.2Classification code 10052358
    E.1.2Term Colorectal cancer metastatic
    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
    The objective of this phase 2 study is to evaluate the antitumor activity, safety, and tolerability of sorafenib versus placebo when used in combination with mFOLFOX6 (5-fluorouracil [5-FU], levo-leucovorin [LLV], and oxaliplatin) in subjects with mCRC who have not been previously treated for Stage IV disease.

    The primary efficacy objective is to compare progression-free survival (PFS) in subjects receiving sorafenib in combination with mFOLFOX6 versus subjects receiving placebo in combination with mFOLFOX6.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to compare the treatment groups in terms of:
    • Overall survival (OS)
    • Time to progression (TTP)
    • Overall response rate (ORR)
    • Duration of overall response (OR)
    • Safety and tolerability
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age > or = 18 years
    • Histological confirmation of adenocarcinoma of the colon or rectum
    • Tumor tissue sample available for KRAS and BRAF assessments
    • Measurable metastatic Stage IV disease (per the American Joint Committee on Cancer [AJCC] Tumor, Node, and Metastasis [TNM] Staging System for CRC) documented within 28 days before randomization)
    • No prior chemotherapy for metastatic CRC
    • At least 1 measurable metastatic lesion that has not been irradiated. The lesion will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST), and be documented by radiological evaluation within 28 days before randomization
    • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
    • Life expectancy of at least 12 weeks
    • Prior radiation therapy is allowed but must be completed at least 28 days before randomization (if applicable)
    • Adequate bone marrow, liver, and renal function as assessed by:
    • Hemoglobin > or = 9.0 g/dL (transfusion and growth factor independent)
    • Platelet count > or = 100,000/mm3 (transfusion independent)
    • Absolute neutrophil count (ANC) > or = 1500/mm3 (growth factor independent)
    • Total bilirubin < or = 2.0 times the upper limit of normal (ULN)
    • Alanine aminotransferase (ALT [SGPT]) and aspartate aminotransferase (AST [SGOT]) < or = 5.0 x ULN in the presence of liver metastasis; ALT (SGPT) and AST (SGOT) < or = 2.5 x ULN in the absence of liver metastasis
    • Prothrombin time (PT) or international normalized ratio for PT (PT INR) < or = 1.5 x ULN and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) < or = 1.5 x ULN
    • Serum creatinine < or = 1.5 times ULN
    • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days before randomization. Both men and women participating in this study must use adequate contraception (eg, abstinence, intrauterine device, oral contraceptive, or double barrier method), beginning at the signing of the Informed Consent Form (ICF) and for > or = 30 days after the last study drug administration
    • Subject must have the ability, in the opinion of the investigator, to comply with all study procedures and follow-up examinations
    • Subjects (and/or legal guardian[s]) must understand and be able and willing to sign an ICF that must be appropriately obtained before undertaking any study specific procedures
    E.4Principal exclusion criteria
    • Prior treatment with sorafenib
    • Clinical or radiographic evidence of brain metastasis
    • Major surgery, open surgical biopsy, or significant traumatic injury within 28 days before randomization; large bore needle biopsy of a major organ within 14 days before randomisation. Placement of central venous access port >= 3 days before randomisation is permitted.
    • Evidence or history of bleeding diathesis or coagulopathy
    • Red blood cell (RBC), white blood cell (WBC), or platelet transfusions and/or growth factor use within 28 days before randomization
    • Adjuvant therapy for CRC (Stage I, II, or III) completed within 12 months before randomization
    • Serious, nonhealing wound, ulcer, or bone fracture
    • A Grade 3 or 4 (per Common Terminology Criteria for Adverse Events v3.0 [CTCAE] dictionary) hemorrhage within 28 days before randomization
    • Use of anticoagulation therapy for the treatment of thrombotic events (such as deep venous thrombosis or pulmonary embolism) or use of anticoagulation therapy resulting in abnormal coagulation parameters. (Low dose anticoagulation therapy to mitigate risk of thrombosis due to placement of a semipermanent central venous port for administration of chemotherapy is allowed.)
    • Uncontrolled hypertension (systolic blood pressure > 150 mmHg or diastolic pressure > 100 mmHg on repeated measurement) despite optimal medical management
    • Thrombolic, embolic, venous, or arterial events (eg, cerebrovascular accident, including transient ischemic attacks) within 6 months before randomization
    • Active cardiac disease including:
    • Congestive heart failure – New York Heart Association (NYHA) > Class II
    • Unstable angina (anginal symptoms at rest), new onset angina (within 3 months), or myocardial infarction within the 6 months before randomization
    • Cardiac ventricular arrhythmias requiring antiarrhythmic treatment within 3 months before randomisation
    • Current peripheral neuropathy > Grade 1 (CTCAE)
    • Subjects with metastatic CRC who are currently candidates for surgery with curative intent (eg, solitary line metastasis)
    • Use of phenytoin, carbamazepine, phenobarbital, St. John’s Wort, or rifampin (rifampicin) within 28 days before randomization
    • Therapeutic anticoagulation with vitamin K antagonists such as warfarin or with heparins and heparinoids, except for:
    • Low-dose warfarin (1mg PO QD) with INR <= 1.5 x ULN is permitted
    • Low-dose aspirin is permitted <= 100mg daily
    • Prophylactic doses of heparins are permitted
    • Current infection > or = Grade 2 (CTCAE)
    • Any anticancer treatment (chemotherapy, hormonal treatment, radiation treatment, surgery, immunotherapy, biologic therapy, or tumor embolization) within 28 days before randomization
    • Any previous or concurrent cancer. Subjects with successfully treated, noninvasive cancers, including cervical cancer in situ, basal cell carcinoma, or superficial bladder tumors (Ta and Tis) will be allowed to participate in the study. Subjects with cancer that was curatively treated > 5 years before randomization will also be allowed to participate in the study
    • Known human immunodeficiency virus infection or chronic hepatitis B or C infection
    • Known or suspected allergy or hypersensitivity to any component of sorafenib, 5-FU, LLV or leucovorin, or oxaliplatin
    • Any medical, psychological, or social condition that may interfere with the subject’s participation in the study or evaluation of the study results
    • Women who are pregnant or breast feeding
    • Subjects who are unable to swallow or retain oral medications
    • Use of any investigational drug within 28 days or 5 half lives of that drug, whichever is longer, before randomization
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is PFS, which will be measured from the date of randomization to the date of first observed progressive disease (PD, radiological or clinical, whichever is earlier) or the date of death due to any cause (if occurring before progression). For subjects without documented progression or death at the time of analysis, the PFS will be censored at the last date of tumor assessment. If a subject has no tumor assessments after Baseline, then the subject will be censored at Day 1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Will be measured from the date of randomization to the date of first observed progressive disease (PD, radiological or clinical, whichever is earlier) or the date of death due to any cause (if occurring before progression)
    E.5.2Secondary end point(s)
    - Overall survival
    - Time to progression
    - Overall response rate
    - Duration of overall response
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall survival will be measured from the date of randomization to death due to any cause.

    Time to progression will be measured from the date of randomization to the date of first observed PD (radiological or clinical, whichever is earlier).


    Duration of OR will be measured from the date of the first documentation of PR or CR (whichever status is recorded first) to the first date that PD or death due to any cause is documented.
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of Life
    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 Yes
    E.8.2.3.1Comparator description
    mFOLFOX6: oxaliplatin, LLV and 5-FU
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA44
    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
    Romania
    Russian Federation
    Spain
    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
    The end of the study is after the occurrence of 120 deaths or approximately 41 months after randomization of the first subject, whichever occurs first.
    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 months2
    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 months2
    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 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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 99
    F.4.2.2In the whole clinical trial 180
    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)
    There is no difference from the expected normal treatment. Subjects should be managed using the standard of care for CRC patients as no additional treatments are required.
    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 Decision2008-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-02-15
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