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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2005-003733-40
    Sponsor's Protocol Code Number:CA183-002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-03-12
    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 number2005-003733-40
    A.3Full title of the trial
    Estudio fase II/III, multicéntrico, aleatorizado, doble ciego y comparativo en primera línea de tratamiento con vinflunina/gemcitabina vs. placebo/gemcitabina en pacientes con carcinoma urotelial de células transicionales (CCT) avanzado no elegibles para recibir tratamiento con cisplatino (VINCENT)

    A Multicenter, Randomized Double-Blind Phase II/III Study in the First-Line Treatment of Advanced Transitional Cell Carcinoma (TCC) of the Urothelium Comparing Vinflunine/Gemcitabine to Placebo/Gemcitabine in Patients who are Ineligible to Receive Cisplatin-Based Therapy
    A.3.2Name or abbreviated title of the trial where available
    VINCENT
    A.4.1Sponsor's protocol code numberCA183-002
    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 SponsorBristol-Myers Squibb International Corporation
    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.3.1Product nameJavlor
    D.3.2Product code BMS-710485-02 / L0070
    D.3.4Pharmaceutical form Concentrate 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 INNVinflunine Ditartrate
    D.3.9.1CAS number 194468-36-5
    D.3.9.2Current sponsor codeBMS-710485-02 / L0070
    D.3.9.3Other descriptive nameVial 10ml
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25.0
    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 RoleComparator
    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 Yes
    D.2.1.1.1Trade name Gemzar
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly and Company Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical 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 INNGemcitabine
    D.3.9.1CAS number 95058-81-4
    D.3.9.3Other descriptive name1g/vial
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboInjection*
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Carcinoma urotelial de células transicionales (CCT) localmente avanzado o metastásico del urotelio

    Locally advanced or metastatic Transitional Cell Carcinoma (TCC) of the urothelium
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10044412
    E.1.2Term Transitional cell carcinoma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the progression-free survival (PFS) between the two treatment arms with progression as defined by Response Evaluation Criteria In Solid Tumors (RECIST) in patients randomized to receive vinflunine/gemcitabine to those randomized to receive placebo/gemcitabine, for first-line locally advanced or metastatic patients with TCC of the urothelium who are not eligible to receive cisplatin-based therapy.
    E.2.2Secondary objectives of the trial
    1) To compare the response rate [Complete Response (CR) + Partial Response (PR), as defined by RECIST] between the two treatment arms.
    2) To compare overall survival (OS) between the two treatment arms.
    3) To compare disease control rate [CR + PR + Stable Disease (SD)] between the two treatment arms.
    4) To estimate the duration of response in each treatment arm.
    5) To estimate time to response in each treatment arm.
    6) To evaluate the safety profile of each treatment.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Provided signed written informed consent

    Target population
    2) Histologic diagnosis of predominantly locally advanced or metastatic transitional cell carcinoma (TCC) of the urothelium (urinary bladder, kidney, renal pelvis, or ureter);
    3) Ineligibility for cisplatin-based therapy because of at least one of the following two medical conditions:
    - Calculated creatinine clearance (Cockroft-Gault formula, see Appendix 3) ≤ 60 mL/min; or,
    - New York Heart Association Classification Stage III-IV Congestive Heart Failure (see Protocol Appendix 4);
    4) Measurable disease documented by imaging with at least one uni-dimensional lesion;
    5) ECOG performance status of 0, 1, or 2 (see Protocol Appendix 5);
    6) The following laboratory parameters:
    − Absolute Neutrophil Count ≥ 1,500 mm3,
    − Platelet count ≥ 100,000 mm3,
    − Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN),
    − Transaminases ≤ 2.5 x ULN [> 5 times ULN only in case of liver metastasis].
    7) If patient received neoadjuvant or adjuvant chemotherapy, he/she must have documented relapse, ≥ 6 months after the last dose of chemotherapy.

    Age and Sex
    8) Men and women ≥ age 18 years of age
    E.4Principal exclusion criteria
    Sex and Reproductive Status
    1) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the study.
    2) WOCBP using a prohibited contraceptive method.
    3) Women who are pregnant or breastfeeding.
    4) Women with a positive pregnancy test on enrollment or prior to study drug administration.
    5) Sexually active fertile men not using effective birth control during the study and up to 6 months after the study if their partners are women of child-bearing potential.

    Target Disease Exceptions
    6) Diagnosis of predominantly non-transitional cell carcinoma of the urothelium (adenocarcinoma, squamous cell carcinoma, small cell, or other) or TCC originating at sites other than the urothelium.
    7) Patients in whom radiation or surgery is indicated.

    Medical History and Concurrent Diseases
    8) Previous systemic chemotherapy treatment for locally advanced or metastatic disease (intravesical treatment is allowed, as well as neoadjuvant and adjuvant chemotherapy that was completed ≥ 6 months before documented PD).
    9) Known brain metastases or leptomeningeal involvement. CT scans are not required unless there is clinical suspicion of central nervous system (CNS) disease.
    10) National Cancer Institute Common Terminology Criteria for Adverse Events (NCI
    CTCAE) (v. 3.0) ≥ Grade 3 peripheral neuropathy.
    11) Prior radiation to ≥ 30% of the bone marrow (See Protocol Appendix 6).
    12) Other serious illness or medical condition including:
    - Infection requiring systemic anti-infective therapy,
    - any medical condition that might be aggravated by treatment or which could not be controlled, for instance patients with unstable angina, patients with myocardial infarction within 6 months and/or poorly controlled hypertension.
    13) Other malignancies except adequately treated basal carcinoma of the skin, in-situ prostrate cancer Gleason ≤ 6, in-situ cervix carcinoma or any other tumor with a disease free interval ≤ 5 years.
    14) Psychological, familial, or sociological conditions which do not permit medical follow-up and/or compliance with the study protocol.

    Physical and Laboratory Test Findings
    15) Inadequate renal function defined by a serum creatinine clearance ≤ 20 mL/min (Cockcroft-Gault formula, see Protocol Appendix 3).

    Allergies and Adverse Drug Reactions
    16) Prior allergic reaction to any vinca alkaloid.

    Prohibited Therapies and/or Medications
    17) Patients who require treatment with ketoconazole, itraconazole, ritonavir, amprenavir and indinavir.
    18) Any concurrent chronic systemic immune therapy (including steroids), chemotherapy, radiation therapy, hormonal therapy (except for physiologic replacement), or any other investigational agent.

    Other Exclusion Criteria
    20) Prisoners or patients who are compulsorily detained
    E.5 End points
    E.5.1Primary end point(s)
    To compare the progression-free survival (PFS) between the two treatment arms with progression as defined by Response Evaluation Criteria In Solid Tumors (RECIST) in patients randomized to receive vinflunine/gemcitabine to those randomized to receive placebo/gemcitabine, for first-line locally advanced or metastatic patients with TCC of the urothelium who are not eligible to receive cisplatin-based therapy.
    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 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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo Yes
    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.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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 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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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 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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 500
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients who discontinue chemotherapy without evidence of Progressive Disease (PD) will continue to be monitored for progression until PD. All patients will be followed-up until death.
    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 Decision2007-03-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-01-18
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    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
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