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   43839   clinical trials with a EudraCT protocol, of which   7280   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:2008-006430-10
    Sponsor's Protocol Code Number:CTKI258A2202
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-05-22
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2008-006430-10
    A.3Full title of the trial
    Estudio Fase II, multicéntrico, abierto, de TKI258 en cáncer de mama HER2 negativo metastático con y sin amplificación del FGFR1
    A.4.1Sponsor's protocol code numberCTKI258A2202
    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 SponsorNovartis Farmaceútica S.A.
    B.1.3.4CountrySpain
    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 TKI258
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeTKI258
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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.IMP: 2
    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 TKI258
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.2Current sponsor codeTKI258
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Cancer de mama HER2 negativo metastático con y sin amplificación del FGFR1
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10006187
    E.1.2Term Breast cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To determine the Overall Response Rate (ORR) in 4 groups of patients with (FGFR1+, HR+),(FGFR1+, HR-),(FGFR1-, HR+) or (FGFR1-, HR-) breast tumors treated with TKI258.
    E.2.2Secondary objectives of the trial
    - To determine Disease Control Rate (DCR), defined according to RECIST, (CR, PR and Stable Disease (SD) &#8805; 24 weeks after start of TKI258 treatment) in the 4 groups of patients
    - Progression Free Survival (PFS), defined according to RECIST, in the 4 groups of patients.
    - To characterize the safety and tolerability of TKI258 treatment.
    - To characterize the single- and repeated-dose pharmacokinetic (PK) profile of TKI258.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female patients with histological confirmation of adenocarinoma of the breast, presenting with metastatic disease.
    2. The primary tumor, metastatic axillary lymph nodes or biopsy of metastatic tumor must have been locally tested by FISH/CISH for FGFR1 amplification. Tumor material must be available for central testing.
    3. HER2 and hormone receptors (ER/PgR) status of breast cancer must have been previously determined.
    4. Patients must have HER2 negative breast cancer.
    5. Patients must have a documented disease progression as defined by RECIST at baseline.
    6. Patients with HR+ disease must have received adjuvant endocrine therapy and at least one line and no more that three lines of chemotherapy in the metastatic setting.
    - Patients with newly diagnosed metastatic disease must have received at least one line endocrine therapy and chemotherapy for metastatic disease.
    7. Patients with HR- disease must have received:
    - djuvant chemotherapy and at least one line and no more than three lines of chemotherapy in metastatic setting
    - Patients who did not receive adjuvant chemotherapy must have received two lines of chemotherapy in the metastatic setting.
    8. Patient must be &#8805; 18 years old.
    9. Patient´s WHO performance status equal to 0, 1 or 2.
    Required baseline laboratory values:
    10. Electrolytes (Ca2+, Na+, Mg2+, K+, phosphorous) level within normal limit
    11. Absolute Neutrophil Count (ANC)&#8805; 1.5 x 109/L
    12. Hemoglobin &#8805; 9 g/dl
    13. Platelets &#8805; 100 x 109/L
    14. Serum creatinine &#8804; 1.5 x ULN
    15. AST/SGOT and ALT/SGPT &#8804; 2.5 x Upper Limit of Normal (ULN) or &#8804; 5.0 x ULN if liver metastases are present
    16. Serum bilirubin &#8804; 1.5 x ULN
    17. All patients must have signed and dated an informed consent form.
    E.4Principal exclusion criteria
    1. Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases
    2. Patients with history of another malignancy within the last 5 years prior to study entry, except cured basal cell carcinoma of the skin or excised carcinoma in situ of the cervix.
    3. Patients who have received the last administration of chemotherapy or immunotherapy &#8804; the timeframe defined below after the end of the cycle of the last treatment, prior to starting study drug, or who have not recovered from the side effects of such therapy: patients who have received the last administration of chemotherapy/immunotherapy in a daily schedule &#8804; 7 days prior to starting study drug; patients who have received the last administration of chemotherapy/immunotherapy in a weekly schedule &#8804; 2 weeks prior to starting study drug; patients who have received the last administration of chemotherapy/immunotherapy in a 2-weekly schedule &#8804;3 weeks prior to starting study drug; patients who have received the last administration of chemotherapy/immunotherapy in a 3-weekly schedule &#8804;4 weeks prior to starting study drug; patients who have received the last administration of chemotherapy/ immunotherapy in a 4-weekly schedule &#8804; 5 weeks prior to starting study drug.
    Patients who have received the last administration of nitrosourea, mitomycin-C &#8804; 6 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy.
    4. Patients who received a continuous dosing small molecule therapeutic &#8804; 7 days prior to starting study drug or who have not recovered from the side effects of such therapy
    5. Patients who received the last administration of biologic therapy &#8804;6 weeks prior to starting study drug or who have not recovered from the side effects of such therapy
    6. Patients who have received any other investigational agents &#8804; 4 weeks prior to starting study drug or who have not recovered from the side effects of such therapy
    7. Patients who have received wide field radiotherapy &#8804; 4 weeks or limited field radiation for palliation &#8804; 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
    8. Patients who have undergone major surgery &#8804; 4 weeks prior to starting study drug or who have not recovered from side effects of such therapy.
    Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study :
    9. Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
    - Congenital long QT syndrome
    - History or presence of ventricular arrhythmias or presence of atrial fibrilation
    - Clinically significant resting bradycardia (< 50 beats per minute)
    - QTc > 480 msec on screening ECG.
    - LVEF assessed by 2-D echocardiogram (ECHO) or Multiple gated acquisition scanning (MUGA), < 45 %.
    10. Any of the following within 6 months prior to study entry: myocardial infarction, severe/unstable angina, CABG, Congestive Heart Failure, Cerebrovascular Accident, Transient Ischemic Attack, Pulmonary Embolism
    11. Uncontrolled hypertension defined by a SBP > 150 mm Hg and/or DBP > 100 mm Hg, with or without anti-hypertensive medication.
    12. Previous pericarditis; clinically significant pleural effusion in the previous 12 months or current ascites requiring two or more interventions/month.
    13. Impairment of gastrointestinal function or GI disease that may significantly alter the absorption of TKI258.
    14. Known diagnosis of HIV infection (HIV testing is not mandatory).
    15. History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the investigator, would impair study compliance.
    16. Patients who are currently receiving anticoagulation treatment with therapeutic doses of warfarin.
    17. Other concurrent severe and/or uncontrolled concomitant medical conditions that could cause unacceptable safety risks or compromise compliance with the protocol.
    18. Pregnant or breast-feeding woman.
    19. Women of child-bearing potential not employing an effective method of birth control. Barrier contraceptives must be used throughout the trial and one month after the end of treatment. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Women of child-bearing potential, defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months), must have a negative serum pregnancy test &#8804; 72 hours prior to starting TKI258.
    E.5 End points
    E.5.1Primary end point(s)
    - Overall Response (Complete responses (CR) or partial response (PR)) Rate. CR and PR will be defined according to 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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
    Biomarkers assessment
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days0
    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 No
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 103
    F.4.2.2In the whole clinical trial 200
    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 Decision2009-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-10
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    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