Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2007-007863-26
    Sponsor's Protocol Code Number:MO18725
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-07-08
    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 ConcernedFrance - ANSM
    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 first line treatment
    A.4.1Sponsor's protocol code numberMO18725
    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 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 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 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 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 INNBevacizunab
    D.3.9.1CAS number 216974-75-3
    D.3.9.2Current sponsor codeRO4876646
    D.3.9.3Other descriptive namerhuMAb, VEGT, 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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Colorectal cancer with primarily unresectable liver metastases
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10052362
    E.1.2Term Metastatic colorectal cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - Resection rate (R0/1/2)
    E.2.2Secondary objectives of the trial
    - Histopathological response
    - 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 (Note: if time interval from last histological diagnosis to enrolment
    exceeds 3 years, new histological confirmation of metastatic disease is required).
    - Male and female patients aged greater than or equal to 18 years and less than or
    equal to 70 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 randomization (at least one of the
    following criteria):
    - No upfront R0 resection of all hepatic lesions possible
    - Less than 30% estimated residual liver after resection
    - Disease in contact with major vessels of the remnant liver.

    E.4Principal exclusion criteria
    - Diagnosis of metastatic disease more than 3 months prior to study entry.
    - 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/radiotherapy completed less than 6
    months prior to study entry.
    - Concomitant use with St John's Wort.
    - Treatment with any other investigational agent, or participation in another clinical
    trial within 30 days prior to entering this study.
    - Current or recent (within 10 days of first dose of study treatment) chronic use of
    aspirin (> 325 mg/day) or clopidrogel (> 75 mg/day).
    - Current or recent (within 10 days prior to study treatment start) use of full-dose
    oral or parenteral anticoagulants or thrombolytic agent for therapeutic (as opposed
    to prophylactic) purposes.
    - 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 treatment start) 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 treatment start), 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 treatment.
    - Central venous access device (CVAD) for chemotherapy administration inserted
    within 2 days prior to study treatment start.
    - 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 < 1.5 x 1000000000/L; platelets < 100 x
    1000000000/L, Hemoglobin (Hb) < 9 g/dL (may be transfused prior to enrolment).
    - INR >1.5 within 7 days prior to starting study treatment. aPTT > 1.5 x ULN within 7
    days prior to starting study treatment.
    - 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 starting study treatment 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 primary study endpoint is the achieved R0 resection rate in those patients rendered resectable after/during first line chemotherapy.
    Patients who achieved successful complete removal of their metastatic lesions will be included in this descriptive analysis.
    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
    bevacizumab+mFOLFOX-6 vs bevacizumab+FOLFOXIRI
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 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
    End of trial = LPLV as per protocol followed by observational period.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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 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) 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 state50
    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 Decision2008-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-21
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat Apr 20 05:39:33 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA