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    Summary
    EudraCT Number:2017-001469-26
    Sponsor's Protocol Code Number:SOGUG-2016-A-IEC(PRO)-12
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-10-20
    Trial 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 number2017-001469-26
    A.3Full title of the trial
    Phase II trial evaluating olaparib maintenance in patients with MCRPC after docetaxel treatment reaching partial or stable response.
    Ensayo fase II para evaluar el tratamiento de mantenimiento con olaparib en pacientes con cáncer de próstata metastásico resistente a la castración (CPMRC) después de haber alcanzado una respuesta parcial o enfermedad estable durante el tratamiento con docetaxel
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II trial evaluating olaparib maintenance in patients with MCRPC after docetaxel treatment reaching partial or stable response.
    Ensayo fase II para evaluar el tratamiento de mantenimiento con olaparib en pacientes con cáncer de próstata metastásico resistente a la castración (CPMRC) después de haber alcanzado una respuesta parcial o enfermedad estable durante el tratamiento con docetaxel
    A.4.1Sponsor's protocol code numberSOGUG-2016-A-IEC(PRO)-12
    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 SponsorSpanish Oncology Genitourinary Group – SOGUG
    B.1.3.4CountrySpain
    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 supportAstraZeneca
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAPICES SOLUCIONES S.L
    B.5.2Functional name of contact pointCLINICAL OPERATIONS DEPARTMENT
    B.5.3 Address:
    B.5.3.1Street AddressAV. Antonio López, 16 -1A
    B.5.3.2Town/ cityPinto
    B.5.3.3Post code28320
    B.5.3.4CountrySpain
    B.5.4Telephone number34918166804100
    B.5.5Fax number34918169172
    B.5.6E-mailana.moreno@apices.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 Yes
    D.2.1.1.1Trade name Lynparza
    D.2.1.1.2Name of the Marketing Authorisation holderAztraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNOLAPARIB
    D.3.9.1CAS number 763113-22-0
    D.3.9.2Current sponsor codeOLAPARIB
    D.3.9.3Other descriptive nameOLAPARIB
    D.3.9.4EV Substance CodeSUB32234
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Metastasic Prostate Cancer Resistant to Castration
    Cáncer de próstata metastásico resistente a la castración
    E.1.1.1Medical condition in easily understood language
    Metastasic Prostate Cancer
    Cáncer de próstata metastásico
    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 10060862
    E.1.2Term Prostate 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
    The primary objective is to assess the effect of maintenance treatment with olaparib on radiologic progression free survival (rPFS) in patients with mCRPC who have received at least 6 cycles of docetaxel and achieved partial or complete response or disease stabilization according RECIST 1.1 criteria and PCWG3
    El objetivo primario es evaluar el efecto del tratamiento de mantenimiento con olaparib en la supervivencia libre de progresión radiológica (rPFS) en pacientes con mCRPC que han recibido al menos 6 ciclos de docetaxel y logrado respuesta parcial o completa o estabilización de la enfermedad de acuerdo con los criterios RECIST 1.1 y PCWG3
    E.2.2Secondary objectives of the trial
    • To assess the effect of maintenance treatment with olaparib on PSA PFS and clinical PFS.
    • To assess the effect of maintenance treatment with olaparib on radiologic response rate (in patients with at least one measurable lesion) and PSA response rate.
    • To assess the safety and tolerability of maintenance treatment with olaparib
    • Evaluar el efecto del tratamiento de mantenimiento con olaparib sobre PSA PFS y PFS clínico.
    • Evaluar el efecto del tratamiento de mantenimiento con olaparib sobre la tasa de respuesta radiológica (en pacientes con al menos una lesión mensurable) y la tasa de respuesta PSA.
    • Evaluar la seguridad y tolerabilidad del tratamiento de mantenimiento con olaparib
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of informed consent prior to any study specific procedures. For inclusion in the study patients must provide the informed consent also for genetic research. Genetic counselling for patients with germline mutation in any of the Homologous Recombination Repair genes should be performed.
    2. Male patients, who must be ≥18 years of age.
    3. Histologically confirmed prostate adenocarcinoma.
    4. Patients must have metastatic disease before starting treatment with docetaxel (metastatic disease documented by positive bone scan or metastatic lesions on CT, MRI).
    5. No prior exposure to platinum, cyclophosphamide, mitoxantrone or PARP inhibitors.
    1. Provisión de consentimiento informado antes de cualquier procedimiento específico del estudio. Para la inclusión en el estudio los pacientes deben proporcionar el consentimiento informado también para la investigación genética. Se debe realizar el asesoramiento genético para pacientes con mutación de línea germinal en cualquiera de los genes Homologous Recombination Repair.
    2. Pacientes varones, que deben tener ≥ 18 años de edad.
    3. Adenocarcinoma de próstata histológicamente confirmado.
    4. Los pacientes deben tener enfermedad metastásica antes de comenzar el tratamiento con docetaxel (enfermedad metastásica documentada por exploración ósea positiva o lesiones metastásicas en la TC, RM).
    5. No hay exposición previa a platino, ciclofosfamida, mitoxantrona o inhibidores de PARP.
    E.4Principal exclusion criteria
    1. Involvement in the planning and/or conduct of the study (applies to AstraZeneca or sponsor staff and/or staff at the study site).
    2. Previous inclusion in the present study.
    3. Participation in another clinical study with an investigational product during the last month.
    4. *Any previous treatment with PARP inhibitor, including olaparib.
    5. Patients who do not have deleterious or suspected deleterious Homologous Recombination Repair genes mutations and only have Homologous Recombination Repair genes mutations that are considered to be non-detrimental (e.g., “Variants of uncertain clinical significance” or “Variant of unknown significance” or “Variant, favour polymorphism” or “benign polymorphism” etc.).
    6. *Other malignancy within the last 5 years except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma, or other solid tumours including lymphomas
    1. Participación en la planificación y / o realización del estudio (se aplica a AstraZeneca o patrocina personal y / o personal en el sitio de estudio).
    2. Inclusión previa en el presente estudio.
    3. Participación en otro estudio clínico con un producto de investigación durante el último mes.
    4. * Cualquier tratamiento previo con inhibidor de PARP, incluyendo olaparib.
    5. Pacientes que no tienen mutaciones perjudiciales o sospechosas de genes Homologous Recombination Repair y que solo tienen mutaciones en los genes de reparación recombinante homóloga que se consideran no perjudiciales (por ejemplo, "Variantes de significado clínico incierto" o "Variante de significado desconocido" o "Variante, polimorfismo favorable" o "polimorfismo benigno", etc.).
    6. Otros tumores malignos en los últimos 5 años excepto: cáncer de piel no melanoma tratado adecuadamente, cáncer de cuello uterino in situ, carcinoma ductal in situ (DCIS), carcinoma de endometrio de grado 1, estadio 1 u otros tumores sólidos incluyendo linfomas
    E.5 End points
    E.5.1Primary end point(s)
    Radiographic progression free survival (rPFS) is defined as the time from treatment with
    olaparib to the date of first disease radiographic progression or death for any reason.
    Radiographic progression disease will be evaluated according RECIST 1.1 criteria and
    PCWG3.
    Supervivencia Libre de Progresion Radiolóigca se define como el tiempo desde el inicio de tratamiento con olaparib hasta la fecha de progresion radiologica o fallecimiento por cualquier causa. Progresion de la enfermedad radiologica será evaluada de acuerdo a criterios RECIST 1.1 y PCWG3.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Evidence of disease progression will be assessed every 12 weeks.
    Evidencia de la progresion de la enfermedad se evaluará cada 12 semanas.
    E.5.2Secondary end point(s)
    - PSA PFS and clinical PFS.
    - Radiologic response rate and PSA response rate.
    - Safety and tolerability
    - SLP de PSA y SLP clinica
    - Tasa de respuesta radiologica y Tasa de respuesta por PSA
    - Seguridad y tolerabilidad
    E.5.2.1Timepoint(s) of evaluation of this end point
    PSA will be evaluated every 4 weeks.
    Radiologic response rate will be evaluated every 12 weeks.
    Safety and tolerability will be evaluated in a onging basis during the treatment.
    PSA será evaluacda cada 4 semanas
    Tasa de respuesta radiológica será evaluada cada 12 semanas
    Seguridad y Tolerabilidad será evaluada de forma continua durante el tratamiento
    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 No
    E.8.1.2Open Yes
    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.8.2 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.8.4.1Number of sites anticipated in Member State concerned8
    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 No
    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
    LVLS
    UVUP
    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
    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: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    F.2 Gender
    F.2.1Female No
    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 state27
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 27
    F.4.2.2In the whole clinical trial 27
    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)
    None
    Ninguno
    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 Decision2017-12-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-21
    P. End of Trial
    P.End of Trial StatusOngoing
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