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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2006-004529-27
    Sponsor's Protocol Code Number:1216.18
    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:2007-05-07
    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 number2006-004529-27
    A.3Full title of the trial
    Multicenter parallel phase II trial of BI 2536 administered as one hour i.v. infusion every 3 weeks in defined cohorts of patients with various solid tumours. A new drug screening program of the EORTC Network of Core Institutions (NOCI)
    A.3.2Name or abbreviated title of the trial where available
    Phase II trial of BI 2536 in pts with various solid tumors
    A.4.1Sponsor's protocol code number1216.18
    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 SponsorSCS Boehringer Ingelheim Comm.V
    B.1.3.4CountryBelgium
    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 No
    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.3.2Product code BI 2536
    D.3.4Pharmaceutical form 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.3.9.2Current sponsor codeBI2536
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.3Concentration number2
    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) 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
    patients with five different tumour entities will be included in the present trial:
    1. squamous cell carinoma of the head and neck
    2. breast cancer
    3. ovarian cancer
    4. soft tissue sarcoma
    5. meanoma
    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
    confirmed response rate as defined by RECIST
    E.2.2Secondary objectives of the trial
    clinical benefit defined as the rate of responders and stable patients (RECIST)
    duration of response in responding patients
    overall progression free survival
    overall survival
    safety profile according to CTCAE Version 3
    plasma concentration time course by using an appropriate population pharmacokinetic model
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Measurable disease based on RECIST with target lesion of at least 20 mm (or 10 mm spiral CT scans) (unidimensionally measurable).
    Documented progressive disease based on RECIST and proven by imaging prior to study entry (i.e. progression should be documented by 2 imaging scans performed within the past 6 months prior to registration showing progression according to RECIST).
    Administration of any prior systemic treatment for the current malignancy must have been completed for at least 4 weeks before first treatment in this trial including treatment with chemotherapy, radiotherapy, immunotherapy, hormonal therapy and treatment with monoclonal antibodies or small molecule tyrosine kinase inhibitors and others.
    Age at least 18 years.
    ECOG PS 0-2.
    Adequate haematological functions: ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L and Haemoglobin ≥ 9 mg/dl.
    Adequate renal function: serum creatinine inferior or equal to 175 µmol/L.
    Bilirubin inferior or equal to 1.5 times ULN. AST/ALT inferior or equal to 2.5 times ULN in absence of liver metastases and inferior or equal to 5 times UNL in case of liver metastases.
    All patients (male and female) must use effective contraception if of reproductive potential. (Effective contraception methods are implants, injectable, combined oral contraceptives, IUDs, sexual abstinence and vasectomised partners for female patients). Females must not be pregnant (pregnancy test) or lactating at screening.
    Before first trial specific procedures are undertaken, written informed consent must be obtained from the patient according to ICH/GCP, and national/local regulations.
    - Head and neck cancer
    Histologically or cytologically proven squamous cell carcinoma of the head and neck (excluding nasopharyngeal primaries).
    Patient presenting with new non irradiated lesions in pre-irradiated field as target lesions are
    eligible.
    Recurrent or metastatic disease, no longer suitable for local therapy.
    Prior use of chemotherapy/chemo radiotherapy/EGFR inhibitors for the treatment of the primary disease/non metastatic disease is allowed.
    No prior chemotherapy for recurrent or metastatic disease. Prior treatment with EGFR inhibitor for metastatic advanced disease is allowed.
    - Breast Cancer
    Histologically proven recurrent or metastatic adenocarcinoma of the breast which failed prior taxane and anthracycline therapy.
    Patient must have had a minimum of one line and a maximum of 2 lines of chemotherapy treatment given either as adjuvant treatment or for recurrence / metastatic disease.
    Patients who do not qualify for Her-2 based therapy.
    - Ovarian cancer
    Histologically proven epithelial ovarian cancer.
    Metastatic or inoperable locally advanced disease.
    Patients either progressing under or relapsing within 6 months of completion of any line of platinum and taxane-based therapeutic regimen for advanced disease.
    - Soft tissue sarcoma
    Histologically proven advanced and/or metastatic malignant soft tissue sarcoma of high or intermediate grade and one of the histologies defined by the WHO classification 2002: leiomyosarcoma, adipocytic sarcoma, synovial sarcoma and others (further described in chapter 3.2.4) but which exclude embryonic rhabdomyosarcoma, chondrosarcoma, osteosarcoma, Ewing tumours/PNET, GIST,
    dermatofibrosarcoma protuberans, inflammatory myofibroblastic sarcoma, neuroblastoma, malignant mesothelioma, mixed mesodermal tumours of the uterus.
    Patients must have received no more than one combination or two single agents of chemotherapy regimen for advanced disease and treatment must have included an anthracycline if not medically contra-indicated.
    - Melanoma
    Patients with histologically proven metastatic malignant melanoma. Ocular melanomas are excluded.
    Patients must either not have received any prior chemotherapy for ecurrent /metastatic disease or have received one line of chemotherapy pending LDH ≤ 2 ULN. One prior line of immunotherapy is allowed.
    E.4Principal exclusion criteria
    clinical evidence of brain metastases.
    presence of any psychological, familial, sociological or geographical factors potentially
    hampering compliance with the study protocol and follow-up schedule; such conditions should be assessed with the patient before registration in the trial.
    other previous and active malignancy for at least 5 years with the exception of cone biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma.
    persistence of toxicities from prior anti-cancer therapy deemed clinically relevant.
    concomitant intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would limit compliance with trial requirement or which are considered relevant for the evaluation of the efficacy or safety of the trial drug.
    treatment with any other investigational drug within the past four weeks or within less than four half-life times of the investigational drug before treatment with the trial drug (whatever is the longest period).
    major surgery within 4 weeks prior to the first treatment with the trial drug.
    E.5 End points
    E.5.1Primary end point(s)
    confirmed response rate (RECIST)
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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 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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA25
    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
    End of study occurs when all of the following criteria have been satisfied:
    1. The trial is mature for the analysis of the primary end-point as defined in the protocol
    2. The database has been fully cleaned and frozen for this analysis for the particular tumor type
    EORTC will follow all patients until their treatment is completed and until death. Data of patients who are still alive and for whom data are collected will be entered in the EORTC database also after the end of the study.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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 years1
    E.8.9.2In all countries concerned by the trial months6
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2007-05-07. Yes
    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.3.3.6.1Details of subjects incapable of giving consent
    women of childbearing potential may be included after havung undergone a pregnancy test which will be repeated before each administration of the trial drug. Patients will be instructed to use contraception
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 205
    F.4.2.2In the whole clinical trial 205
    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 Decision2007-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-07-09
    P. End of Trial
    P.End of Trial StatusCompleted
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