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    Summary
    EudraCT Number:2008-005870-11
    Sponsor's Protocol Code Number:CTKI258A2201
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-03-01
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2008-005870-11
    A.3Full title of the trial
    A Phase II multi-center, non-randomized, open-label study of TKI258 in patients with either FGFR3 mutated or FGFR3 wild type advanced urothelial carcinoma.
    A.3.2Name or abbreviated title of the trial where available
    ND
    A.4.1Sponsor's protocol code numberCTKI258A2201
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberND
    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 FARMA
    B.1.3.4CountryItaly
    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.3.1Product nameDovitinib
    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.3.9.1CAS number 692737-80-7
    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
    FGFR3 mutated or FGFR3 wild type advanced urothelial carcinoma.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064467
    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) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) in patients with (FGFR3MUT) advanced urothelial carcinoma treated with TKI258 To determine the Overall Response Rate (ORR) as assessed by RECIST in patients with (FGFR3WT) advanced urothelial carcinoma treated with TKI258.
    E.2.2Secondary objectives of the trial
    To determine Overall Response Rate (ORR) as per central assessment in both groups To determine Progression Free Survival (PFS) and Overall Survival (OS) in both groups To determine Disease Control Rate (DCR - Complete Response (CR), Partial Response (PR) and Stable Disease (SD) &#8805;16 weeks after start of TKI258 treatment) in both groups To characterize the safety and tolerability of TKI258 treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients with histological confirmation of transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis Locally advanced or metastatic disease 2. Archival tumor tissue available for Novartis designated FGFR3 mutational status analysis 3. Patients with documented progressive disease at baseline: progressive disease defined as new or progressive lesions on cross-sectional imaging 4. Patients with at least one measurable site of disease as defined by RECIST criteria that has not been previously irradiated 5. Previously treated with at least 1 but not more than 3 systemic cytotoxic regimens, with at least one of these regimens including at least one of the following: cisplatin, carboplatin, gemcitabine or taxane, administered in the perioperative or advanced setting and may have been administered sequentially (e.g., first-line treatment followed by second-line treatment at time of progression) or as part of a single regimen 6. Age &#8805; 18 years 7. WHO Performance Status &#8804; 2 8. Willing and able to take oral medication, comply with scheduled visits, treatment plan and laboratory tests 9. Signed and witnessed informed consent form obtained prior to any screening procedures 10. Required baseline laboratory values: Absolute neutrophil count (ANC) &#8805; 1,500 cells/mm3 [SI units 1.5 x 109/L] Platelets &#8805; 100,000 cells/mm3 [SI units 100 x 109/L] Hemoglobin &#8805; 9.0 g/dL [SI units 90 g/L] AST/SGOT and ALT/SGPT &#8804; 3.0 x Upper Limit of Normal [ULN] (or AST/SGOT and ALT/SGPT &#8804; 5 x ULN if abnormal liver function is due to tumor involvement of the liver) Bilirubin &#8804; 1.5 x ULN Serum creatinine &#8804; 1.5 x ULN Potassium within normal limits Sodium within normal limits Total Calcium (corrected for serum albumin) within normal limits Magnesium within normal limits Phosphorus within normal limits
    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 five years prior to study entry,except cured basal cell carcinoma of the skin, excised carcinoma in situ of the cervix, or adenocarcinoma of the prostate that has been surgically treated with a post-treatment PSA that is non-detectable 3.Patients who have received the last administration of an anti-cancer therapy, including:chemotherapy, immunotherapy, hormonal therapy, and targeted therapy, but excluding: nitrosourea, mitomycin-C, monoclonal antibodies, and radiation &#8804; 14 days prior to starting study drug, or who have not recovered from side effects of such therapy 4.Patients who have received the last administration of nitrosourea or mitomycin-C &#8804; 6weeks 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 an anti-cancer monoclonal antibody &#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 wide field radiotherapy (including therapeutic radioisotopes such as strontium 89) &#8804; 4 weeks or limited field radiation for palliation &#8804; 2 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy 7.Patients who have undergone major surgery &#8804; 2 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy 8.Any of the following concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study: a.Impaired cardiac function or clinically significant cardiac diseases, (SEE THE PROTOCOL)b. Previous pericarditis; clinically significant pleural effusion in the previous 12 months or current ascites requiring two or more interventions/month c. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of TKI258 (e.g. ulcerative diseases, uncontrolled nausea, vomiting,diarrhea, malabsorption syndrome, or small bowel resection) d.Known diagnosis of human immunodeficiency virus (HIV) infection (HIV testing is not mandatory) e.History of alcoholism, drug addiction, or any psychiatric or psychological condition which, in the opinion of the investigator, would impair study compliance f. Patients who are currently receiving anticoagulation treatment with therapeutic doses of warfarin g.Uncontrolled diarrhea &#8805; CTCAE grade 2 h. Other concurrent severe and/or uncontrolled concomitant medical conditions (e.g. active or uncontrolled infection) that could cause unacceptable safety risks or compromise compliance with the protocol i.Pregnant or breast-feeding women j.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 have had menses any time in the preceding 24 consecutive months), must have a negative serum pregnancy test &#8804; 72 hours prior to starting TKI258 k. Fertile males not willing to use contraception or whose female partners are not using adequate contraceptive protection
    E.5 End points
    E.5.1Primary end point(s)
    Overall Response (CR or PR) Rate. CR and PR will be defined according to RECIST (defined in Post-Text Supplement 1) as per local assessment.
    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 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 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) 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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 years1
    E.8.9.1In the Member State concerned months10
    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 months2
    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 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) No
    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 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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 80
    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 Decision2010-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-04-04
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