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   44234   clinical trials with a EudraCT protocol, of which   7336   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:2005-000586-19
    Sponsor's Protocol Code Number:307971
    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:2005-12-05
    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 - BfArM
    A.2EudraCT number2005-000586-19
    A.3Full title of the trial
    Phase-II study to investigate the efficacy and safety of ZK 219477 as second-line therapy in patients with Stage IIIB or Stage IV non-small-cell lung cancer (NSCLC)
    A.4.1Sponsor's protocol code number307971
    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 SponsorBayer Schering 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 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.3.2Product code SH Y03757A
    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 INNnot available
    D.3.9.2Current sponsor codeZK 219477
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10,5
    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.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 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 Information not present in EudraCT
    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
    Non small cell lung cancer (NSCLC) stage IIIB or stage IV
    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 investigate the efficacy of ZK 219477 in platinum-pretreated patients with NSCLC (proof of concept)
    E.2.2Secondary objectives of the trial
    To investigate the safety and tolerability of the above treatment
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Pharmacogenomics – Biomarker discovery
    (optional study module), Attachment 4 to study protocol, dated 14.04.2005

    The evaluation of pharmagenomics (here DNA methylation) is an optional module of this study. From each participating patient, a 12-mL blood sample will be taken prior to first dose of study medication.

    The objective of the biomarker discovery program within the framework of this clinical trial is to assess promoter methylation in selected genes potentially involved in the pathogenesis of NSCLC and search for correlation between the pattern of methylated sequences and tumor response.

    2. Pharmacokinetics (optional substudy), Attachment 5 to stuy protocol, dated 18.07.2006 - Further investigation of the pharmacokinetic profile of ZK 219477 when infused over 30 minutes and over 3 hours

    The evaluation of pharmakokinetic is an optional module of this study. For each patient, a total of 13 respectively 15 blood samples is scheduled to be collected per course for pharmacokinetic analysis.


    3. Pharmacogenomics – Biomarker Analysis (optional study module), Attachment 6 to study protocol, dated 20.07.2007

    The objective of the biomarker discovery program within the framework of this clinical trial is to search for correlation between tumor-specific pharmacogenomic and pharmacogenetic characteristics and clinical response to treatment with ZK 219477.
    In particular, these exploratory analyses aim to detect:
    1. Associations between gene expression in tumor tissue and drug response to find predictors or indicators of response to the study medication, ZK 219477.
    2. Associations between protein biomarkers in blood and drug response to find predictors or indicators of response to the study medication, ZK 219477.
    3. Association between the mutational status of the p53 gene in tumor tissue and drug response to find predictors or indicators of response to the study medication, ZK 219477.
    4. Associations between methylated tumor DNA markers in blood and drug response to find predictors or indicators of response to the study medication, ZK 219477.

    The procedures from attachment 4 are integrated in the new attachment 6. Patients participating in the biomarker substudy described in attachment 6 will not have to sign the informed consent form for the biomarker substudy procedures described in attachment 4.
    Patients can still participate in the biomarker substudy as described in attachment 4, if they are not willing to make their tissue samples available.
    E.3Principal inclusion criteria
    1. Males or females aged ≥ 18 years

    2. Histologically or cytologically proven NSCLC, Stage IIIB or Stage IV

    3. At least 1 unidimensionally measurable lesion (suitable for modRECIST
    evaluation)

    4. WHO performance status 0 to 1

    5. Treatment failure of one previous platinum-based chemotherapy regimen

    6. Time period since prior therapy:
    - Prior radiotherapy: ≥ 3 weeks
    - Prior chemotherapy: ≥ 3 weeks
    - Prior immunotherapy: ≥ 3 weeks

    7. Adequate recovery (excluding alopecia) from previous surgery, radiation, and
    chemotherapy

    8. Adequate function of major organs and systems
    • Nervous system:
    - No Grade 2 or greater peripheral neuropathy
    • Hematopoietic:
    - Hemoglobin: ≥ 10 g/dL
    - WBC: ≥ 3,000/mm3
    - Absolute neutrophil count: ≥ 1,500/mm3
    - Platelet count: ≥ 100,000/mm3
    • Hepatic:
    - Total bilirubin: normal
    - AST/ALT: ≤ 2.5 times the upper limit of normal
    • Renal:
    - Creatinine: ≤ 2 mg/dL
    • Cardiovascular:
    - No symptomatic congestive heart failure
    - No unstable angina pectoris
    - No arrhythmia needing continuous treatment
    • No other uncontrolled concurrent illness

    9. Survival expectation ≥ 3 months

    10. Negative pregnancy test at enrollment (females of childbearing potential only)

    11. Agreement to use highly effective contraception methods (intra-uterine
    contraceptive device IUCD, condoms, oral contraceptives, or other adequate
    barrier contraception) in females of child-bearing potential

    12. Written informed consent
    E.4Principal exclusion criteria
    1. More than one previous chemotherapy regimen for advanced disease

    2. Prior treatment with epothilones

    3. Use of any investigational drug within 4 weeks before start of study treatment
    or inadequate recovery from any toxic effects of such therapy

    4. Candidacy for curative resection

    5. Symptomatic brain metastases requiring whole-brain irradiation

    6. Active infection

    7. Breast feeding

    8. Any condition that in the opinion of the investigator could hamper the
    compliance with the study protocol

    9. History of any other primary malignancy with the exceptions of non- melanoma skin cancer and carcinoma in situ of the cervix
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with either CR or PR as ‘best overall response’
    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 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.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 No
    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) 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 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 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
    Last patient last visit
    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 months0
    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 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 2005-12-05. 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 state114
    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 Decision2005-06-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-07-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-04-15
    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
    EMA HMA