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    Summary
    EudraCT Number:2005-006161-13
    Sponsor's Protocol Code Number:ML19983
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-10-25
    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 ConcernedGermany - PEI
    A.2EudraCT number2005-006161-13
    A.3Full title of the trial
    A single arm Phase II study to assess efficacy and safety of bevacizumab in combination with the standard therapy (interferon alfa-2a and vinblastine) as first-line treatment for patients with metastatic renal cell cancer (Bevacizumab with standard therapy in RCC)
    A.3.2Name or abbreviated title of the trial where available
    Bevacizumab with standard therapy in RCC
    A.4.1Sponsor's protocol code numberML19983
    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 SponsorRoche Pharma 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 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 25 mg/ml
    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.3.11 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 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
    Metastatic renal cell cancer
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To asses the efficacy of the combination therapy with interferon alfa-2a, vinblastine and bevacizumab in patients with metastatic renal cell carcinoma (RCC) based on progression free survival.
    E.2.2Secondary objectives of the trial
    - To characterise the safety profile of the combination of bevacizumab with interferon alfa-2a and vinblastine based on the rate of adverse events with CTCAEv3.0 Grade 3, 4 or 5.
    - To determine the feasibility of the combination of bevacizumab and interferon alfa-2a and vinblastine.
    - To evaluate the course of blood pressure.
    - To assess the efficacy of the combination based on overall survival.
    - To determine the response rate of the combination based on the RECIST criteria.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Willingness to give written informed consent for study participation and for data protection (legal requirement in Germany: ‘Datenschutzrechtliche Einwilligung’).

    • Patient must be willing and able to comply with the protocol.

    • Patients with metastatic renal cell carcinoma of predominantly clear cell type with at least one measurable lesion according to RECIST criteria.

    • Patient was nephrectomized for primary clear cell renal cell carcinoma and postsurgical wound healing is completed..

    • Age ≥ 18 years.

    • ECOG Performance status ≤ 2.

    • The required laboratory values at screening are as follows:
    Hematology:
    - Absolute neutrophil count ≥ 1.5 x 109/L
    - Platelet count > 100 x 109/L.
    - Hemoglobin > 9 g/dL (may be transfused to maintain or exceed this level).
    - International Normalized Ratio (INR) ≤ 1.5 x upper limit of normal (ULN); aPTT ≤ 1.5 x ULN.
    Biochemistry:
    - Total bilirubin ≤ 1.5 x ULN.
    - AST, ALT ≤ 2.5 x ULN in patients without liver metastases; < 5 x ULN in patients with liver metastases.
    - Serum creatinine < 2.0 mg/dL or 177 µmol/L or calculated creatinine clearance ≥ 35 mL/min.
    Absence of proteinuria at baseline defined as:
    - Patients with < 1+ proteinuria on dipstick urinalysis.
    - Patients with ≥ 1+ proteinuria on dipstick urinalysis, who demonstrate < 0.5 g of protein/24 h on 24-h urine collection.

    • Life expectancy greater than 3 months.

    • Evaluation of tumor-manifestation 4 weeks or less before start of therapy by RECIST criteria.
    E.4Principal exclusion criteria
    • Prior treatment with chemotherapy, cytokine or tyrosine kinase inhibitor therapy for RCC (including neo-adjuvant or adjuvant therapy).

    • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study.

    • Serious non-healing wound, ulcer or bone fracture.

    • Evidence of bleeding diathesis or coagulopathy.

    • Hemapoetic diseases.

    • Serious dysfunction of bone marrow.

    • History or other evidence of ischemic retinopathy.

    • Uncontrolled thyroid disease.

    • Uncontrolled hypertension.

    • Contraindications of the standard therapy (interferon alfa-2a and vinblastine).

    • Seizure(s) not controlled with standard medical therapy.

    • Ongoing or recent (within 10 days prior to study treatment start) need for full therapeutic dose of oral or parenteral anticoagulants or chronic daily treatment with aspirin (> 325 mg/day).

    • Patients with a medical condition requiring chronic systemic corticosteroids at a dosage of > 10 mg/kg BW methylprednisolone equivalent, excluding inhaled steroids.

    • History or presence of other malignancies within the last 5 years (except: cervical carcinoma in situ and basal cell or squamous cell carcinoma of the skin).

    • Clinically significant (i.e. active) cardiovascular disease, for example cerebrovascular accidents (≤ 6 months), myocardial infarction (≤ 6 months), unstable angina, New York Heart Association (NYHA) grade ≥ II congestive heart failure, or serious cardiac arrhythmia requiring medication.

    • Women, lactating, pregnant or of childbearing potential and fertile men not using a highly effective contraceptive method (Allowed methods of birth control, i.e. with a failure rate of ≤ 1% per year, are implants, injectables, combined oral contraceptives intrauterine devices (only hormone spirals), sexual abstinence or vasectomized partner for up to 6 months after end of treatment). [Women of childbearing potential must have a negative pregnancy test (serum ß-HCG) within 7 days before the first dose of study drug].

    • Evidence of current central nervous system (CNS) metastases or spinal cord compression. If clinically indicated, patient must undergo a MRI or CT scan of the brain (with contrast, if possible) within 28 days prior to inclusion.

    • Known infection with HBC, HCV, HIV (no testing required)

    • History or presence of autoimmune disease (i.e. thyroid autoimmune dysfunction).

    • Uncontrolled bacterial infection of any kind.

    • Evidence of allergy or hypersensitivity against the used medication and its ingredients.

    • Allogenic transplants with a need for immunosuppressive therapy.

    • History or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications.

    • History or presence of a neuromuscular disease.

    • Recent (within the 30 days prior to inclusion) treatment with another investigational drug or recent/current participation in another investigational study.

    • Patients who have participated in this study before.

    • Patients who are underage or patients who are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 Abs. 4, § 41 Abs. 2 and Abs. 3 AMG).

    • Patients who are confined by order either of judicial or administrative authorities (according to § 40 Abs. 1 No. 4 AMG).

    • Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study.

    • Patients who possibly are dependent on the sponsor or investigator.
    E.5 End points
    E.5.1Primary end point(s)
    Median progression free survival (PFS). Progression is defined according to RECIST criteria.
    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 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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned30
    E.8.5The trial involves multiple Member States No
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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 Information not present in EudraCT
    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 state180
    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 Decision2006-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-06-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-01-21
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