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    The EU Clinical Trials Register currently displays   43841   clinical trials with a EudraCT protocol, of which   7281   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:2007-007591-42
    Sponsor's Protocol Code Number:SPON416-07(WCTU011)
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-10-09
    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 ConcernedUK - MHRA
    A.2EudraCT number2007-007591-42
    A.3Full title of the trial
    A Phase II single-arm trial to evaluate cisplatin and gemcitabine chemotherapy in combination with sunitinib for first-line treatment of patients with advancd transitional carcinoma of the urothelium.
    A.3.2Name or abbreviated title of the trial where available
    SUCCINCT
    A.4.1Sponsor's protocol code numberSPON416-07(WCTU011)
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) Number54607216
    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 SponsorCardiff University
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Yes
    D.2.1.1.1Trade name SUTENT
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/05/267
    D.3 Description of the IMP
    D.3.1Product nameSutent
    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.3.8INN - Proposed INNSunitinib
    D.3.9.1CAS number 341031-54-7
    D.3.9.2Current sponsor codeSU-0011248
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12.5
    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 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
    Advanced transitional cell carcinoma of the urothelium.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10005003
    E.1.2Term Bladder cancer
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10038517
    E.1.2Term Renal pelvis cancer NOS
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10046375
    E.1.2Term Ureter cancer
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of this trial is to assess whether the addition of sunitinib to standard cisplatin / gemcitabine (CG) cancer chemotherapy improves outcome for participants with advanced cancer of the urinary system (urothelial cancer). The primary objective is to assess the activity, safety and feasibility of using the 3−drug combination (SCG) in patients with advanced transitional cell carcinoma of the urothelium. The primary outcome measure is progression−free survival (PFS) at 6 months from date of enrolment. This is the proportion of participants who are alive at 6 months without disease progression, according to RECIST (Response Evaluation Criteria In Solid Tumours).
    E.2.2Secondary objectives of the trial
    The secondary objectives are to determine:
    • Toxicity, during and after treatment
    • Tolerability (side effects) and feasibility of use (number of participants requiring dose delays or reduction and / or treatment withdrawal)
    • Overall survival, defined by time from enrolment to death by any cause. Those still alive will be censored at the time last seen.
    • Progression−free survival (time−to−event). Time from registration to any disease progression (based on RECIST) and/or death. Those progression−free and alive will be censored at the time last seen.
    • Objective (radiological) response rate based on RECIST
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Participants will be asked to participate in an optional sub-study of the main SUCCINCT trial (see full title provided in Section A.3 of this form) and detailed in Setion 12.0 Ancillary Studies of the trial protocol supplied with this application (Version Number 3.0, 4th August 2010). All SUCCINCT participants will be asked to consider the provision of additional blood samples before and after the SUCCINCT trial treatment, and for permission to analyse previous tumour tissue specimens (e.g. from prior TURBT and/or cystectomy / nephro-ureterectomy). The objective is to analyse these samples to gain a better understanding of the 3-drug SCG treatment in urothelial cancer.
    E.3Principal inclusion criteria
    1. Age greater than or equal to 16 years
    2. Histologically confirmed transitional cell carcinoma (pure or mixed histology) of urothelium (upper or lower urinary tract)
    3. Radiologically measurable, locally advanced and/or metastatic disease not amenable to curative treatment with surgery
    or radiotherapy: (a) T4b (bladder) / T4 (renal pelvis / ureter) Nany Many, (b) Tany N2−3 Many, (c) Tany Nany M1
    4. Estimated life expectancy greater than 3 months
    5. WHO performance status 0−2
    6. Fit to receive cisplatin−containing combination chemotherapy
    7. No prior systemic therapy for locally advanced or metastatic disease − patients who have received prior neoadjuvant or adjuvant chemotherapy for urothelial cancer (up to 4 cycles), completed at least 6 months prior to first documented disease progression will remain eligible
    8. No prior radiotherapy within 1 month prior to registration or involving more than 30% of total bone marrow volume
    9. No investigational drug within 1 month prior to registration
    10. Adequate renal function (GFR >60mL/min, uncorrected for surface area and measured by isotopic means)
    11. Adequate bone marrow function (absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L; Plts greater than or equal to 100 x 109/L at baseline)
    12. Adequate liver function (Bili less than or equal to 1.5x ULN; ALT and ALP less than or equal to 2.5 ULN at baseline)
    13. Prothrombin time (PT) or International normalised ratio (INR) less than or equal to 1.5 x ULN
    14. Written informed consent
    E.4Principal exclusion criteria
    1. Patients with urothelial cancer in whom subsequent radical treatment is being considered with a view to possible cure
    2. Previous malignancy other than non−melanoma skin cancer, cervical carcinoma in situ or incidental localised prostate cancer
    3. Previously identified CNS metastases − routine baseline CT scanning of the head is not a requirement for trial entry and should only be performed if clinically indicated
    4. Women who are pregnant or breast feeding. Women of childbearing potential must have a negative pregnancy test performed within 7 days prior to the start of trial therapy
    5. Men and women not prepared to practice method(s) of birth control of established efficacy
    6. Known infection with human immunodeficiency virus (HIV) or chronic hepatitis B or C
    7. Uncontrolled hypertension
    8. Symptomatic coronary artery disease, myocardial infarction within the last 6 months, congestive cardiac failure >NYHA class II, uncontrolled or symptomatic cardiac arrhythmia
    9. Clinically significant bacterial or fungal infection
    10. Concurrent anticoagulant therapy with warfarin or un−fractionated heparin − patients requiring anti−coagulation may be entered after successful conversion to low molecular weight heparin (LMWH)
    11. Concomitant medications which have known adverse interactions with the trial treatment
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is activity defined as progression−free survival at 6 months from date of enrolment. This is the proportion of patients who are alive at six months without disease progression, according to Response Evaluation Criteria in Solid Tumours (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 Yes
    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 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 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 concerned12
    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 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
    For the purpose of complying with UK Medicines for Human Use (Clinical Trial)
    Regulations introduced in May 2004, the trial will be considered closed when the last
    participant has completed protocol treatment. However, further observational follow
    up will continue for a minimum of one year.
    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 months0
    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 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 Yes
    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) Yes
    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 state63
    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)
    Further sunitinib treatment will not be available after the 18 week treatment period. Once the participant has completed the trial treatment any other treatment outside of the trial will be at the discretion of the local Research Doctor. Each participant will remain in the study for at least 12 months, to allow the final follow up assessment to be completed at 52 weeks from the date of enrolment, and adequate follow-up of Serious Adverse Events (SAEs).
    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 Decision2008-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-18
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