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    Summary
    EudraCT Number:2007-007863-26
    Sponsor's Protocol Code Number:MO18725
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-06-10
    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 ConcernedAustria - BASG
    A.2EudraCT number2007-007863-26
    A.3Full title of the trial
    A multicentre randomized phase II study to assess the safety and resectability in patients with primarily unresectable liver metastases secondary to colorectal cancer receiving treatment with 5-FU, leucovorin, oxaliplatin and bevacizumab with or without irinotecan as 1st line treatment.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study with bevacizumab in combination with standard of care treatment (mFOLFOX-6 or FOLFOXIRI) to assess the safety and the possibility to surgically remove liver metastasis (spread of the disease to the liver) in patients with inoperable liver metastasis secondary to bowel cancer.
    A.3.2Name or abbreviated title of the trial where available
    OLIVIA
    A.4.1Sponsor's protocol code numberMO18725
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 12
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+41616881111
    B.5.5Fax number+41616919319
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 Avastin
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    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 INNBevacizunab
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeRO4876646
    D.3.9.3Other descriptive namerhuMAb VEGF, anti-VEGF
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeRecombinant humanised monoclonal antibody
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Colorectal cancer with initially unresectable liver metastases
    E.1.1.1Medical condition in easily understood language
    Bowel cancer with initially inoperable liver metastases (spread of the disease to the liver)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.0
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    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
    - Overall resection rate (R0 / R1 / R2)
    E.2.2Secondary objectives of the trial
    - Histopathological response (assessment of viable tumour cells within the resected specimen)
    - Relapse-free survival (RFS)
    - Progression-free survival (PFS)
    - Overall survival (OS)
    - Overall response rate (ORR)
    - Time to response (TTR)
    - Surgical safety
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically confirmed carcinoma of the colon and/or rectum with evidence of liver
    metastases.
    - Male and female patients aged greater than or equal to 18 years.
    - ECOG performance score of 0 or 1.
    - Written informed consent.
    - General condition considered feasible for major abdominal surgery after first line treatment.
    - Unresectability of hepatic metastases at randomisation (at least one of the following criteria):
    - No upfront R0 / R1 resection of all hepatic lesions possible
    Note: a patient with bilobar disease suitable for a two-stage
    resection would still fulfil the inclusion criteria for
    unresectability.
    - Less than 30% estimated residual liver after resection
    - Disease in contact with major vessels of the remnant live
    (vessels remaining after potential hepatectomy)
    E.4Principal exclusion criteria
    - Evidence of extrahepatic metastatic disease (excluded by FDG-PET).
    - Evidence of diffuse peritoneal carcinosis or involvement of celiac lymph nodes.
    - Prior systemic or local treatment of metastatic disease.
    - Prior adjuvant or neo-adjuvant chemotherapy for primary tumour completed less than 6 months prior to randomisation (Note: in case of synchronous metastatic rectal cancer, chemotherapy/radiotherapy for primary tumour is allowed within 6 months of randomisation).
    - Treatment with any other investigational agent within 30 days prior to randomisation or participation in another clinical trial while participating in this clinical trial.
    - Current or recent (within 10 days of randomization) chronic use of aspirin (> 325 mg/day) or clopidrogel (> 75 mg/day).
    - History or evidence upon physical/neurological examination of CNS disease (unrelated to cancer) (unless adequately treated with standard medical therapy) e.g. uncontrolled seizures.
    - Past or current history (within the last 2 years prior to randomization) of other malignancies except metastatic colorectal cancer (patients with curatively treated basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible).
    - Clinically significant cardiovascular disease, for example CVA, myocardial infarction (less than or equal to 12 months before randomization), unstable angina, New York Heart Association (NYHA) greater than or equal to Class II, congestive heart failure (CHF), arrhythmia requiring medication, or uncontrolled hypertension.
    - Evidence of bleeding diathesis or coagulopathy.
    - Known hypersensitivity to any of the study drugs.
    - Serious, non-healing wound, ulcer or bone fracture.
    - Major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization.
    - Evidence of any other disease, metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
    - Life expectancy less than 3 months.
    - Inability or unwillingness to comply with the protocol.
    - Inadequate haematological function: ANC < 1.5x1000000000/L; platelets <100x1000000000/L, Hemoglobin (Hb) < 9 g/dL (may be transfused prior to enrolment).
    - INR >1.5 within 7 days prior to randomization. aPTT >1.5 x ULN within 7 days prior to randomization.
    - Liver function: Serum bilirubin > 1.5 x ULN; alkaline phosphatase and transaminases > 5 x ULN (liver metastases).
    - Serum Creatinine > 1.5 x ULN.
    - Urine dipstick for proteinuria grater than or equal to 2+. If urine dipstick is greater than or equal to 2+, 24-hour urine must demonstrate less than or equal to 1 g of protein in 24 hours for patient to be eligible.
    - Pregnancy or lactation.
    - Positive serum pregnancy test within 7 days of randomization in pre-menopausal women and women < 2 years after the onset of menopause. Note: a negative test has to be reconfirmed by a urine test, should the 7-day window be exceeded.
    - Fertile women (< 2 years after last menstruation) and men of childbearing potential unwilling or unable to use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile).


    E.5 End points
    E.5.1Primary end point(s)
    The overall incidence of achieved R0/R1/R2 resections in patients rendered resectable after/during pre-operative chemotherapy
    E.5.2Secondary end point(s)
    Secondary study endpoints include assessment of the following parameters after pre-operative/post-operative treatment with bevacizumab and chemotherapy:
    - Histopathological response
    - Relapse-free survival
    - Progression-free survival
    - Overall survival
    - Overall response rate (ORR)
    - Time to response
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 years after LPLV
    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 Yes
    E.6.13.1Other scope of the trial description
    Biomarker research
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Only exploratory comparisons between the 2 arms (bev+mFOLFOX-6 and bev+FOLFOXIRI) are conducted
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 EEA18
    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 No
    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
    The study will end approximately 2 years after the last patient has been enrolled. At that time, no further data will be collected for the clinical database for this study and no further study treatment will be provided. Thereafter, patient follow-up and treatment will be governed by local standard of
    care. The safety reporting requirements for serious adverse events will remain as per clinical practice.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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 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.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    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)
    N.A.
    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 Decision2008-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-02
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-21
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