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    Summary
    EudraCT Number:2013-005095-18
    Sponsor's Protocol Code Number:ICR-CTSU/2013/10041
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2014-08-12
    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 ConcernedUK - MHRA
    A.2EudraCT number2013-005095-18
    A.3Full title of the trial
    A phase II randomised feasibility study of chemoresection and surgical management in low risk non muscle invasive bladder cancer.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Investigating Bladder Chemotherapy Instead of Surgery for Low Risk Bladder Cancer (CALIBER)
    A.3.2Name or abbreviated title of the trial where available
    CALIBER
    A.4.1Sponsor's protocol code numberICR-CTSU/2013/10041
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN24855462
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02070120
    A.5.4Other Identifiers
    Name:NIHR Reference NumberNumber:PB-PG-0712-28112
    Name:Sponsor Identifier NumberNumber:CCR4134
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorThe Institute of Cancer Research
    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 supportNational Institute for Health Research
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitute of Cancer Research
    B.5.2Functional name of contact pointSteven Penegar
    B.5.3 Address:
    B.5.3.1Street AddressICR-CTSU
    B.5.3.2Town/ city15 Cotswold Road, Sutton, Surrey
    B.5.3.3Post codeSM2 5NG
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02087224238
    B.5.5Fax number02087707876
    B.5.6E-mailcaliber-icrctsu@icr.ac.uk
    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.2.1.1.1Trade name Mitomycin-C Kyowa
    D.2.1.1.2Name of the Marketing Authorisation holderProStrakan Ltd
    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.3.1Product nameMitomycin-C
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravesical use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMitomycin C
    D.3.9.1CAS number 50-07-7
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Low risk non muscle invasive bladder cancer
    E.1.1.1Medical condition in easily understood language
    This cancer affects the cells which line the inside of the bladder.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10005005
    E.1.2Term Bladder cancer recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Can chemotherapy in the bladder (chemoresection) enable the avoidance of surgery for those diagnosed with a recurrence of low risk non-muscle invasive bladder cancer?
    E.2.2Secondary objectives of the trial
    Do patient acceptance (proportion of patients approached who consent to join) and recruitment rates support the development of a phase III randomised trial of chemoresection or surgical management for low risk non-muscle invasive bladder cancer?

    Is chemoresection treatment acceptable to participants and feasible to deliver at participating NHS sites?

    If chemoresection/surgery has been successful (by assessment at 3 months), how long do patients remain disease free?

    For patients whose disease returns in both groups, in what proportion does it subsequently progress to a life threatening condition?

    What type of surgical management is currently in use at participating sites?

    What is the rate of surgery subsequent to the initial treatment of recurrence in both groups?

    What are the side effects of both treatments as measured by clinicians?

    What is the impact of both treatments on participants' quality of life and their subsequent use of the health service?
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The main CALIBER trial will have two associated sub studies which are embedded in the main CALIBER protocol:

    Quality of Life (QL) and Health Service Utilisation (HSU)
    The objective of the QL assessment is to describe and compare the impact of chemoresection and surgical management on physical, social and emotional wellbeing. The objective of the HSU study is to measure the impact of each treatment on participants' subsequent usage of health services.

    CALIBER Translational sub study (CALIBER-T)
    Participation in CALIBER-T will be optional. CALIBER participants will be asked to donate sequential urine samples to investigate potential diagnostic biomarkers. Participants will also be asked to provide one blood sample and consent to donate their routinely collected bladder/tumour tissue samples.
    E.3Principal inclusion criteria
    1. Written informed consent
    2. NMIBC recurrence following original diagnosis of low risk NMIBC (defined as Ta G1 or Ta G2 (Ta low grade) with a risk of recurrence score of ≤6 using EORTC risk tables).
    3. Histologically confirmed TCC at original diagnosis
    4. Aged 16 or over
    5. Satisfactory pre-treatment haematology values haemoglobin > 100 g/L and serum creatinine < 1.5xULN
    6. Negative pregnancy test for women of child-bearing potential
    E.4Principal exclusion criteria
    1. Any history of: grade 3/high grade or ≥T1 transitional cell carcinoma, concomitant carcinoma in situ, more than 7 tumours at one diagnosis or more than 1 recurrence per year since initial diagnosis or in the past five years, whichever is shorter
    2. Any history of histologically confirmed non-TCC bladder cancer
    3. Trial entry recurrence identified within 11.5 months of the date of the original diagnosis
    4. Any prior treatment of the trial entry recurrence (including biopsy)
    5. Previous MMC chemotherapy other than a single instillation at diagnostic surgery
    6. Known allergy to MMC
    7. Carcinoma involving the prostatic urethra or upper urinary tract (participants should have had imaging of the upper urinary tract within 2 years prior to randomisation)
    8. Known or suspected reduced bladder capacity (<100ml)
    9. Significant bleeding disorder
    10. Female patients who are breast-feeding or are of childbearing potential and unwilling or unable to use adequate non-hormonal contraception. Male patients should also use contraception if sexually active.
    11. Active or intractable urinary tract infection
    12. Urethral stricture or anything impeding the insertion of a catheter
    13. Large narrow neck diverticula
    14. Significant urinary incontinence
    15. Any other conditions that in the Principal Investigator’s opinion would contraindicate protocol treatment
    16. Unable or unwilling to comply with study procedures or follow up schedule
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure is the proportion of patients who have a complete response (CR) to chemoresection at 3 months. This is defined as an absence of any tumour following chemoresection and will be assessed visually at check cystoscopy by patients’ urologists.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The main time point of interest is three months post-treatment.
    E.5.2Secondary end point(s)
    In the chemoresection group:
    • Treatment compliance. Patients who receive 4 MMC instillations with no more than 14 days between each instillation will be described as fully compliant.
    In both groups:
    • Time to recurrence in patients disease free at 3 months, defined as time from randomisation to time of first local or distant recurrence
    • Transurethral resection and biopsy rates
    • Progression free survival, defined as time from randomisation to the first of muscle invasive bladder recurrence, recurrence in the pelvic nodes, metastatic recurrence or death
    • Toxicity CTCAE
    • Quality of life as measured by EORTC-C30 and BLS24 questionnaires. Domains of interest include global health / QL, functioning domains, urinary symptom scales and items relating to side effects associated with MMC and surgical management.
    • Health service utilisation as measured by the health service usage questionnaire.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients will be evaluated at each of the clinical visits for safety and tolerability end points. Response end points will be evaluated at cycle 4 weeks, 3 months, 6 months and the final trial specific evaluation is twelve months post-treatment. Further data relating to secondary survival endpoints will be collected from routine follow up visits and national electronic health databases.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    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.8.1.7.1Other trial design description
    Simon’s 2 stage phase II design. Patients randomised 2:1 in favour of chemoresection group.
    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 No
    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
    The study end date is deemed to be the date of last data capture.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days30
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 74
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state89
    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)
    Not applicable, participants will finish treatment on trial.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-08
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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