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    Summary
    EudraCT Number:2011-003517-42
    Sponsor's Protocol Code Number:SPI-1012
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-03-09
    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 ConcernedSpain - AEMPS
    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).
    Estudio aleatorio de fase 3 internacional, multi céntrico, doble ciego, controlado con placebo, para evaluar la eficacia y seguridad de la instilación intravestical múltiple de apaziquone vs. placebo en pacientes con Riesgo Bajo-Medio de Cáncer de Vejiga sin Invasión de la Musculatura.
    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.
    Un estudio clínico internacional de estadíos tardíos en pacientes cuyo cancer de vejiga no es músculo invasivo y con un riesgo bajo-medio de volver a tener un cáncer de vejiga después de la cirugía. El estudio comparará la eficacia y seguridad entre apaziquona y una sustancia inactiva. Los pacientes recibirán apaziquona o sustancia inactiva de forma aleatoria. Ni el paciente ni el personal del estudio conocerán el tratamiento y éste se suministrará directamente en la vejiga.
    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 organisationLeón Research S.L.
    B.5.2Functional name of contact pointRocío García Cañamaque
    B.5.3 Address:
    B.5.3.1Street AddressBurgo Nuevo 16, 1-G
    B.5.3.2Town/ cityLeón
    B.5.3.3Post code24001
    B.5.3.4CountrySpain
    B.5.4Telephone number+34987261064NA
    B.5.5Fax number+34987216243NA
    B.5.6E-mailrgcanamaque@leonresearch.es
    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.
    La patología en investigación es el cancer de vejiga no invasivo en pacientes con resección transuretral del tumor/tumores de vejiga.
    E.1.1.1Medical condition in easily understood language
    Low-intermediate risk non muscle-invasive bladder cancer
    Pacientes con Riesgo Bajo-Medio de Cáncer de Vejiga sin Invasión de la Musculatura
    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
    Tiempo de recurrencia del cancer en la vejiga
    E.2.2Secondary objectives of the trial
    Recurrence rate at 24 months
    Recurrence rate at 12 months
    Time to Progression
    Safety and tolerability
    Tasa de recurrencia a los 24 meses
    Tasa de recurrencia a los 12 meses
    Tiempo a la progresión
    Seguridad y tolerabilidad
    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
    Criterios de inclusión en la fase abierta
    1. El paciente ha dado el consentimiento, quiere participar y entiende el protocolo?
    2. Tiene el paciente 18 años o más?
    3. Si es una mujer en edad fértil, utiliza métodos anticonceptivos aceptables?
    4. Mujer en edad fértil, tiene una prueba de embarazo negativa en la selección?
    5. Tiene el paciente con apariencia clínica primaria o grado bajo de recurrencia Ta:
    -tumores múltiples (2-7)
    -Un tumor no único > 3 cm
    -No historia / evidencia de Tis
    O tiene el paciente con apariencia clínica primaria o grado alto de recurrencia Ta:
    -Un tumor único de ? 3 cm
    -No historia / evidencia de Tis
    6. Es el paciente capaz de retener las instilaciones de vejiga por un mínimo de 60 minutos (+/- 6 minutos)?
    7. Se hizo una evaluación del tracto urinario superior para excluir el carcinoma urotelial, hidronefrosis o carcinoma de células renales u otro cáncer de riñón en los 6 meses previos a la selección del estudio?
    8. Está la uretra del paciente (incluyendo la uretra prostática en hombres), por endoscopia, libre de cualquier TCC?
    9. Para los pacientes con tumor recurrente, se le hizo al paciente una citoscopia por lo menos hace 6 meses que confirme la ausencia de tumor en el intervalo entre la última recurrencia tumoral y el momento de la selección?
    10. Para hombres con un PSA entre 4 y 10 ng/mL hay una evaluación diagnóstica que excluya de forma razonable el diagnóstico de cancer de próstata en opinión del investigador?

    Criterios de inclusión para la fase ciega
    1. Fue todo el tumor visible resecado en el TURBT inicial?
    -La revisión patológica central del tumor en la vejiga del paciente confirma:
    -Enfermedad tumoral de grado bajo Ta para tumores múltiples (2 - 7) o
    -Enfermedad de grado alto Ta para tumor individual
    -No evidencia microscópica de invasión linfovascular y/o evidencia de tumor tromboembólico
    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?
    1. Ha recibido el paciente radioterapia pélvica previa (incluye radiación externa o braquiterapia)?
    2. Ha recibido el paciente alguna vez apaziquone?
    3. Ha recibido el paciente un curso de inducción (completadas 5 de 6 instilaciones semanales programadas) de BCG intravesical (± interferon) con la última dosis recibida en menos de doce meses?
    4. Ha tenido el paciente quimioterapia intravesical previa, exclusiva o en dosis única, como quimioterapia adyuvante intravesical inmediatamente despues del TURBT?
    5. Ha tenido el paciente historia de retención urinaria o post vaciado residual ? 250 cc por escaner vesical o ultrasonido (la prueba de post vaciado residual se puede repetir hasta 3 veces)?
    6. Ha tenido o tiene el paciente cualquier tumor de vejiga con histología diferente al carcinoma de células transicionales?
    7. Ha tenido o tiene el paciente carcinoma de células transicionales micro-papilares?
    8. Si el paciente tiene enfermedad papilar recurrente de la vejiga, ha sido esta patología algo distinto de pTa en el pasado?
    9. Tiene el paciente una infección activa del tracto urinario confirmada por cultivo o una historia documentada de infección de tracto urinario recurrente (? 6 para mujeres y ?2 para hombre por año) en los dos años previos?
    10. Tiene el paciente algún desajuste sanguíneo o un recuento plaquetario en la selección < 50 x 109/L?
    11. Tiene el paciente una hemoglobina en la selección < 10 g/dL?
    12. Tiene el paciente masculino un PSA sércio en la selección > 10 ng/mL?
    13. Tiene el paciente historia de Síndrome de Inmunodeficiencia adquirida o VIH positivo?
    14. Tiene el paciente cualquier condición médica concurrente severa y/o incontrolada (ej. diabetes incontrolada, fallo cardiaco congestivo descontrolado, infarto de miocardio, en los 6 meses previos al estudio, hipertensión inestable e incontrolada, o infección activa incontrolada) o enfermedad psiquiátrica, que pudiese comprometer su participación en el estudio, el cumplimiento con las visitas del mismo y/o la finalización del estudio?
    15. Ha participado el paciente en cualquier protocolo de investigación en los últimos 90 días?
    16. Está la paciente embarazada o en periodo de lactancia?
    17. Tiene la paciente una esperanza de vida de <3 años?
    18. Tiene la paciente cualquier otra malignidad/neoplasia o ha recibido tratamiento para cualquier otra malignidad/neoplasia en los últimos 5 años excepto
    -Tumores de la piel distintos al melanoma
    -carcinoma cervica de estadío 0 (in situ)
    -PSA indetectable durante ?1 año tras la terapia definitiva para el cancer de próstata localizado?
    19. Tiene el paciente reflujo vesico-uretral documentado o un stent uretral interno?
    20. Tiene el paciente el tumor en un divertículo de la vegija?
    21. Tiene el paciente alergia conocida al tinte rojo de la comida?
    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.
    Tiempo cuando se confirma la primera recurrencia de cancer de vejiga después de la TURBT durante el que todos los tumores se habían resecado y el paciente había recibido una dosis de producto en investigación en el periodo post quirúrgico después de la TURBT seguido de seis instilaciones semanales de medicación en estudio o de 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
    Se seguirá al paciente por citoscopia cada 3 meses para recurrencia tumoral durante un periodo total de 24 meses desde el momento en que recibió la primera instilación del producto.
    E.5.2Secondary end point(s)
    Recurrence rate in 24 months
    Recurrence rate in 12 months
    Time to progression
    Safety and Tolerability
    Tasa de recurrencia a los 24 meses
    Tasa de recurrencia a los 12 meses
    Tiempo a la progresión
    Seguridad y tolerabilidad
    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.
    Se seguirá al paciente por citoscopia cada 3 meses para recurrencia tumoral durante un periodo total de 24 meses desde el momento en que recibió la primera instilación del producto. Los efectos adversos y los efectos adversos graves, relacionados y no relacionados, se recogerán y revisarán continuamente para evaluar la seguridad y tolerabilidad.
    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 concerned7
    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.
    El final del ensayo se define como la última visita del último paciente
    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
    Pacientes que no pueden leer y/o escribir personalmente
    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.
    El tratamiento y los cuidados después de que el paciente haya terminado su participación en el estudio serán el tratamiento y los cuidados estandarizado sin ningún tipo de restricción.
    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 Decision2012-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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