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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:2011-003517-42
    Sponsor's Protocol Code Number:SPI-1012
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-06-15
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2011-003517-42
    A.3Full title of the trial
    A Phase 3 International, Multicenter, Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Multiple Instillations of Intravesical Apaziquone vs. Placebo in Patients with Low-Intermediate Risk Non-Muscle Invasive Bladder Cancer (NMIBC).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An international late stage clinical study in patient who’s bladder cancer is not muscle invasive and has a low-intermediate risk of bladder cancer returning after surgery. The study will compare the effectiveness and safety between apaziquone and an inactive substance. Randomly patient will receive either apaziquone or inactive substance. Study treatment will be unknown to both patient and study staff and treatment will be given into the bladder directly.
    A.4.1Sponsor's protocol code numberSPI-1012
    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 SponsorSpectrum Pharmaceuticals, Inc
    B.1.3.4CountryUnited States
    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 supportSpectrum Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmaTrials-Polska
    B.5.2Functional name of contact pointSandra Mateus
    B.5.3 Address:
    B.5.3.1Street AddressBVO - Estrada de Paço D'arcos, nº 66-66A sala 2-20
    B.5.3.2Town/ cityCacém
    B.5.3.3Post code2735-336
    B.5.3.4CountryPortugal
    B.5.4Telephone number00351210985234
    B.5.5Fax number00351210985236
    B.5.6E-mailsandra.mateus@pharmatrials.pl
    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 nameapaziquone
    D.3.4Pharmaceutical form Powder for solution for intravesical use
    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 INNapaziquone
    D.3.9.1CAS number 114560-48-4
    D.3.9.2Current sponsor codenot applicable
    D.3.9.3Other descriptive nameE09, NOR-701, NSC-382459, EOquin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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
    D.8.3Pharmaceutical form of the placeboPowder for solution for intravesical use
    D.8.4Route of administration of the placeboIntravesical use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The medical condition under investigation is noninvasive bladder cancer in patients undergoing transurethral resection of bladder tumor/tumors.
    E.1.1.1Medical condition in easily understood language
    Low-intermediate risk non muscle-invasive bladder cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10005007
    E.1.2Term Bladder cancer stage 0, without cancer in situ
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10005003
    E.1.2Term Bladder cancer
    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
    Time to recurrence of cancer in the bladder
    E.2.2Secondary objectives of the trial
    • Recurrence rate at 24 months
    • Recurrence rate at 12 months
    • Time to Progression
    • Safety and tolerability
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Open Phase Inclusion Criteria
    1. Has the patient given written informed consent and is the patient willing and able to abide by the protocol?
    2. Is the patient 18 years old or above?
    3. If the patient is a female of childbearing potential, is she using an acceptable/effective method of contraception?
    4. Does the female patient of childbearing potential have a negative serum pregnancy test at screening?
    5. Does the patient with clinically apparent primary or recurrent low grade Ta NMIBC have :
    • multiple tumors (2-7)
    • No single Tumor > 3 cm
    • No history / evidence of Tis
    Or does the patient with clinically apparent primary or recurrent high grade Ta NMIBC have:
    • A single tumor that is ≤ 3 cm
    • No history / evidence of Tis
    6. Is the patient able to retain bladder instillations for a minimum of 60 minutes (+/- 6 minutes)?
    7. Did the patient have upper urinary tract evaluation to exclude urothelial carcinoma, hydronephrosis or renal cell carcinoma or other renal cancers in the 6 months prior to study screening?
    8. Is patient’s urethra (including prostatic urethra in men) endoscopically free of any visible TCC?
    9. For patients with recurrent tumor, did the patient have at least a 6-month cystoscopically-confirmed tumor-free interval between the last tumor recurrence and the time of screening?
    10. Has the male patient with a prostate specific antigen (PSA) between 4 and 10 ng/mL had a diagnostic evaluation that reasonably excludes the diagnosis of prostate cancer in the opinion of the Investigator?
    Double-Blind Phase Inclusion Criteria
    1. Was all visible tumor resected at the initial TURBT?
    2. Does Central Pathology review of the patient’s bladder tumor confirm:
    • Low grade Ta disease for multiple tumors (2 - 7) or
    • High Grade Ta disease for single tumor
    • No microscopic evidence of lymphovascular invasion and/or evidence of tumor thromboemboli

    All questions must be answred 'YES' in order for patient to be included in the study.
    E.4Principal exclusion criteria
    1. Has the patient received any previous pelvic radiotherapy (includes external beam and/or brachytherapy)?
    2. Has the patient ever received apaziquone?
    3. Has the patient received an induction course (completed 5 of 6 scheduled weekly instillations) of intravesical BCG (± interferon) with the last dose given less than 12 months ago?
    4. Has the patient had any prior intravesical chemotherapy, exclusive of single-dose adjuvant intravesical chemotherapy immediately post-TURBT?
    5. Does the patient have a history of urinary retention or a post void residual ≥ 250 cc by bladder scan or ultrasound (post void residual test may be repeated up to 3 times)?
    6. Does the patient have or has the patient had any bladder tumor with histology other than transitional cell carcinoma?
    7. Does the patient have or has the patient had micro-papillary transitional cell carcinoma?
    8. If the patient has recurrent papillary disease of the bladder, has the pathology been anything other than pTa in the past?
    9. Does the patient have an active urinary tract infection confirmed by culture or a documented history of recurrent UTI (≥ 6 for females and ≥2 for males per year) in the prior 2 years?
    10. Does the patient have a bleeding disorder or a screening platelet count < 50 x 109/L?
    11. Does the patient have a screening hemoglobin < 10 g/dL?
    12. Does the male patient have a screening serum PSA > 10 ng/mL?
    13. Does the patient have a history of Acquired Immunodeficiency Syndrome or HIV positive?
    14. Does the patient have a condition or a concurrent severe and/or uncontrolled medical or psychiatric disease (e.g., uncontrolled diabetes, decompensated congestive heart failure, myocardial infarction within 6 months of study, unstable and uncontrolled hypertension, or an active uncontrolled infection), which could compromise participation, compliance with scheduled visits and/or completion of the study?
    15. Has the patient participated in an investigational protocol within the past 90 days?
    16. Is the patient pregnant or breast feeding?
    17. Does the patient have a life expectancy of <3 years?
    18. Has the patient had any other malignancy or received therapy for any malignancy in the last five years except
    • non-melanoma skin tumors
    • stage 0 (in situ) cervical carcinoma
    • undetectable PSA for ≥1 year following definitive therapy for localized prostate cancer?
    19. Does the patient have documented vesicoureteral reflux or an indwelling ureteral stent?
    20. Does the patient have tumor in a bladder diverticulum?
    21. Does the patient have a known allergy to red color food dye?

    The patient will not be entered into study if any of above listed questions is answered YES.
    E.5 End points
    E.5.1Primary end point(s)
    Time when there is first confirmed recurrence of bladder cancer after the initial TURBT during which all tumors have been resected and patient has received one dose of IMP in the immediate post operative period after TURBT followed by either 6 weekly instillations of IMP or placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patient will be followed by cystosopy every 3 months for tumor recurrence for the total duration of 24 months from the time of receiving the first IMP instillation
    E.5.2Secondary end point(s)
    Recurrence rate in 24 months
    Recurrence rate in 12 months
    Time to progression
    Safety and Tolerability
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patient will be followed by cystosopy every 3 months for tumor recurrence for the total duration of 24 months from the time of receiving the first IMP instillation. Advrese events and serious events both related and unrealted will be collected and reviewed on ongoing basis to assess safety and tolerability.
    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) No
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned21
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Czech Republic
    Netherlands
    Poland
    Portugal
    Slovakia
    Spain
    United States
    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
    End of trial is defined by last study visit of the last subject.
    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 months6
    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 months6
    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.1.2.1Number of subjects for this age range: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients who can not read or/and write by themself
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 450
    F.4.2.2In the whole clinical trial 670
    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)
    The treatment or care after the subject has ended his/her participation in the trial will be the investigator's standard normal treatments and care without any restrictions.
    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 Decision2012-09-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2013-02-21
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