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   43932   clinical trials with a EudraCT protocol, of which   7307   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

    EudraCT Number:2004-004648-29
    Sponsor's Protocol Code Number:C05002
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2005-04-22
    Trial results View results
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2004-004648-29
    A.3Full title of the trial
    A Multicenter, Open-label, Phase 2 Study of VELCADE (bortezomib) for Injection in Previously Treated Patients with Stage IIIB and IV Bronchioloalveolar Carcinoma and Adenocarcinoma with Bronchioloalveolar Features
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberC05002
    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 SponsorJanssen Cilag International, N.V. (Sponsor in European Union)
    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.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 Information not present in EudraCT
    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 nameVELCADE 3.5 mg powder for solution for injection
    D.3.2Product code PS-341, 26866138-AAA-PB-001
    D.3.4Pharmaceutical form Powder 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 INNbortezomib
    D.3.9.1CAS number 179324-69-7
    D.3.9.2Current sponsor code26866138
    D.3.9.3Other descriptive nameBoronic Acid: [(1R)-3-methyl-1-[[(2S)-1-oxo-3-phenyl-2[(pyrazinylcarbonyl)amino]propyl]amino]butyl
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.5
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    Stage IIIB and IV Bronchioloalveolar Carcinoma and Adenocarcinoma with Bronchioloalveolar Features
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to determine the efficacy of VELCADE in terms of tumor response rate [Complete Response (CR) and Partial Response (PR)] using the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines in patients with advanced bronchioloalveolar carcinoma (BAC) or adenocarcinoma with BAC features that have progressed on or after Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors (EGFR TKI).
    E.2.2Secondary objectives of the trial
    - Determine the duration of response, disease control rate, time to progression
    (TTP), and survival following VELCADE therapy.
    - Assess the toxicity and tolerability of VELCADE therapy.
    - Correlate somatic mutations in k-ras and EGFR genes with response to VELCADE
    - Explore the association between somatic mutations and expression levels in genes
    that may be involved in BAC prognosis or response to VELCADE therapy (p53, cyclin
    D1, Ki-67, p21cip1, p27kipl, thyroid transcription factor-1 (TTF-1), osteopontin,
    proteasome subunits).
    - Assess patient reported outcomes (PROs) using quality of life (QOL) instruments
    [EORTC-QLQ-C30 with its lung cancer module QLQ-LC13, and the Lung Cancer
    Symptom Scale (LCSS)].
    - Assess the medical resource utilization (MRU) related to the disease and the
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Have histologically confirmed BAC or adenocarcinoma with BAC features.
    2. Have stage IIIB (malignant pleural effusion) or stage IV disease.
    3. Have disease that has progressed on or after treatment with an EGFR TKI
    (Iressa or Tarceva).
    4. Have radiographic documentation of Progressive Disease (PD) as determined by
    the investigator.
    5. Have measurable disease by RECIST, defined as at least 1 lesion that can be
    accurately measured in at least 1 dimension as >20 mm with conventional tech-
    niques or >10 mm with spiral CT scan; the longest diameter is to be recorded.
    6. Are 18 years of age or older.
    7. Have a life expectancy greater than 3 months.
    8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of
    0, 1, or 2.
    9. Are able to provide written informed consent in accordance with all applicable
    regulations and follow the study procedures. Patients must be capable of un-
    derstanding the investigational nature, potential risks and benefits of the study.
    E.4Principal exclusion criteria
    1. Have a histological diagnosis of BAC or adenocarcinoma with BAC features based
    solely on the following sample types:
    · fine needle aspirate (FNA)
    · sputum cytology
    · bronchial brushings and washings cytology (bronchioalveolar lavage)
    · bronchial biopsy (bronchial wall only with no alveolar parenchyma, or
    mediastinoscopy with lymph node metastasis only).
    2. Have had conventional cytotoxic chemotherapy within 3 weeks prior to en-
    rollment or treatment with an EGFR TKI within 2 weeks prior to enrollment.
    3. Have peripheral neuropathy of Grade 2 or greater intensity, as defined by the
    National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events
    (CTCAE 3.0).
    4. Have documented greater than 10% weight loss in the 6 weeks prior to
    5. Have been previously treated with VELCADE.
    6. Have experienced myocardial infarction within 6 months prior to enrollment or
    have New York Hospital Association (NYHA) Class III or IV heart failure, un-
    controlled angina, electrocardiographic evidence of acute ischemia, or clinically
    significant and poorly controlled arrhythmias.
    7. Have had radiation therapy within 4 weeks prior to enrollment.
    8. Have had monoclonal antibody therapy within 4 weeks prior to enrollment.
    9. Have had any major surgery within 4 weeks prior to enrollment
    10. Have inadequate organ function at the Screening Visit as defined by the
    following laboratory values:
    - Platelet count <100 x 109/l
    - Hemoglobin <8.0 g/dl
    - Absolute neutrophil count (ANC) <1.5 x109/l
    - Aspartate transaminase (AST) >3 times the upper limit of the normal range
    - Alanine transaminase (ALT) >3 times ULN
    - Creatinine >1.8 mg/dl
    - Total bilirubin >1.5 times ULN or >=5 times ULN in patients with liver
    11. Have brain metastases that have not been completely resected or have not
    completely responded to treatment with radiation therapy and there is evidence
    of residual disease; or that require ongoing treatment with corticosteroids.
    12. Have uncontrolled active systemic infection requiring treatment
    13. Have evidence of a co-existing advanced or metastatic malignancy other than
    BAC or adenocarcinoma with BAC features.
    14. Have a history of allergic reaction attributable to compounds containing boron or
    15. Have known human immunodeficiency virus (HIV) positive or hepatitis B surface
    antigen-positive status or known active hepatitis C infection. Patients assessed
    by the investigator to be at risk for HIV, hepatitis B or C infection should be
    tested in accordance with local regulations.
    16. Have poorly controlled hypertension, diabetes mellitus, or another serious
    medical or psychiatric illness that could, in the investigator's opinion, potentially
    interfere with the completion of treatment according to this protocol.
    17. Are a pregnant or breast-feeding female. Confirmation that the patient is not
    pregnant must be established by a negative serum or urine beta-human
    chorionic gonadotropin (beta-hCG) pregnancy test result obtained during the
    Screening Period. Pregnancy testing is not required for post-menopausal or
    surgically sterilized women.
    18. Are of childbearing potential and are unwilling to employ adequate means of
    contraception (condoms, diaphragm, birth control pills, injections, intrauterine
    device, or abstinence) during study treatment and through 30 days after the last
    dose of study treatment.
    19. Are currently receiving or have previously received an investigational agent for
    any reason within 4 weeks of enrollment.
    E.5 End points
    E.5.1Primary end point(s)
    The study's primary endpoint is the efficacy of VELCADE therapy as measured by objective tumor response rate (CR and PR) in patients with locally advanced (stage IIIB) or metastatic (stage IV) BAC or adenocarcinoma with BAC features who have progressed following receipt of 1 or 2 prior lines of chemotherapy, which must have included an EGFR-TKI.
    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 No
    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 Information not present in EudraCT
    E.6.11Pharmacogenomic Yes
    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. 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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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.8.6 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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    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 defined as 6 months following the last dose of the patient on study, at which time no further patient assessment will take place.
    This definition has been chosen in order to ensure that the time related endpoint objectives can be met.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    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 Information not present in EudraCT
    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 2005-04-22. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 135
    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 Decision2005-04-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-05-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2008-07-16
    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 © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands