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    Summary
    EudraCT Number:2017-002808-28
    Sponsor's Protocol Code Number:OZM-061
    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 number2017-002808-28
    A.3Full title of the trial
    Olala Trial: A Retrospective/Prospective Analysis of Characterization of the Long-Term Responders on Olaparib in Solid Tumours
    Olala: Análisis retrospectivo/prospectivo de caracterización de pacientes que responden a largo plazo al tratamiento con olaparib en tumores sólidos
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to examine the characteristics of patients with solid tumors who have long-term benefit from Olaparib
    Un ensayo para examinar las caracteristicas de pacientes con tumores solidos que obtienen beneficio a largo plazo con Olaparib
    A.3.2Name or abbreviated title of the trial where available
    Olala
    Olala
    A.4.1Sponsor's protocol code numberOZM-061
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02489058
    A.5.4Other Identifiers
    Name:SMS-protocol codeNumber:SMS-0389
    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 SponsorPrincess Margaret Cancer Centre
    B.1.3.4CountryCanada
    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 supportAstra Zeneca
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSMS-oncology
    B.5.2Functional name of contact pointMiranda Kleijn
    B.5.3 Address:
    B.5.3.1Street Address1098XH
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1098XH
    B.5.3.4CountryNetherlands
    B.5.4Telephone number310204350580
    B.5.5Fax number310204350589
    B.5.6E-mailregulatory@sms-oncology.com
    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 (olaparib)
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca 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 Tablet
    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.3.9.3Other 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 number800
    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
    epithelial ovarian cancer (including fallopian tube or peritoneal cancer)
    cancer de ovario
    E.1.1.1Medical condition in easily understood language
    tumor of the ovary
    tumor de ovario
    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 10061328
    E.1.2Term Ovarian epithelial 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
    To clinically, molecularly and genomically characterize patients with long term and short term disease control on olaparib in terms of:
    • Somatic BRCA mutation
    • Homologous recombination repair (HRR) deficiency panel
    • Genomic sequencing
    • Immune profile
    • PI3K/Akt pathway expression
    • Gene expression
    Caracterizar clínica, molecular y genómicamente a las pacientes con un control de la enfermedad a largo y corto plazo con olaparib en términos de lo siguiente:
    • Mutación de BRCA somática
    • Panel de deficiencia de reparación de recombinación homóloga (HRR)
    • Secuenciación genómica
    • Perfil inmunológico
    • Expresión de la vía PI3K/Akt
    • Expresión genética
    E.2.2Secondary objectives of the trial
    • To define the HRR deficiency profile
    • Define the level of poly (ADP-ribose) (PAR) expression by immunohistochemistry
    • To compare the signature of PARP response with the signature of platinum sensitivity which have been previously assessed in patients with long response to platinum based chemotherapy
    • To assess the signature of PARP response and PARP resistance on different tumour sites
    • To define how patients take olaparib in the long term setting

    Exploratory objectives:
    • To characterize the tumor profile at disease progression
    • To assess the pharmacokinetics and pharmacogenomics of olaparib for patients still on treatment
    • To assess circulating tumor DNA (ctDNA) at the time of response on olaparib and at progression
    • Definir el perfil de déficit de HRR
    • Definir el nivel de expresión de poli ADP ribosa (PAR) mediante inmunohistoquímica
    • Comparar la firma de la respuesta de PARP con la firma de la sensibilidad de platino que se haya evaluado previamente en pacientes con una larga respuesta a quimioterapia basada en platino
    • Evaluar la firma de la respuesta de PARP y la resistencia a PARP en distintos sitios de tumores
    • Definir cómo los pacientes toman olaparib a largo plazo
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    To characterize the tumor profile at disease progression. Part of main protocol.
    Caracterizar el perfil del tumor en la progresión de la enfermedad. Parte del protocolo
    E.3Principal inclusion criteria
    Inclusion Criteria:
    1. Previous or current treatment with Olaparib in a clinical trial/standard of care that included one of the following as a first step study for epithelial ovarian cancer (including fallopian tube or peritoneal cancer) :
    • single agent olaparib given for relapsed disease
    or
    • single agent olaparib given as maintenance therapy after response to platinum based chemotherapy
    or
    • olaparib combined with platinum based chemotherapy and then continued as maintenance therapy
    or
    • olaparib combined with other types of therapy
    2. Had a durable response to Olaparib defined as patients who have benefited from olaparib for ≥ 2 years.
    or
    The control group is patients who had a short duration benefit with Olaparib of less than 3 months in any individual clinical trial/standard of care
    3. Ability to understand and the willingness to sign a written informed consent document.
    4. Subject is willing and able to comply with scheduled visits, laboratory tests, and other study procedures
    1. Tratamiento previo o actual con olaparib en un ensayo clínico o estándar de atención médica que haya incluido uno de los tratamientos siguientes como ensayo primario para el cáncer epitelial de ovario (incluido el cáncer de trompas de Falopio o peritoneal):

    • olaparib como único agente administrado para enfermedad recidivante
    o bien
    • olaparib como único agente administrado como tratamiento de mantenimiento después de la respuesta a quimioterapia basada en platino
    o bien
    • olaparib combinado con quimioterapia basada en platino y continuado como tratamiento de mantenimiento
    o bien
    • olaparib combinado con otros tipos de tratamiento


    2. Personas con una respuesta duradera a olaparib, es decir, pacientes que han obtenido beneficios de olaparib durante ≥ 18 meses

    o bien

    El grupo de control consta de pacientes que han obtenido beneficios de corta duración con olaparib de menos de 6 meses, en un ensayo clínico o estándar de atención médica individual.


    3. Capacidad para entender y voluntad para firmar un documento de consentimiento informado.

    4. Voluntad y capacidad de la paciente para cumplir con las visitas programadas, las pruebas de laboratorio y otros procedimientos del estudio.
    E.4Principal exclusion criteria
    Exclusion Criteria:
    1. Any severe acute or chronic medical or psychiatric condition or laboratory abnormality that would render the patient unsuitable for biopsy
    2. Pregnant or breastfeeding women
    1. Cualquier trastorno médico o psiquiátrico grave, agudo o crónico, o anomalía de laboratorio que puedan hacer que el paciente no sea apto para una biopsia
    2. Mujeres embarazadas o en período de lactancia
    E.5 End points
    E.5.1Primary end point(s)
    To clinically, molecularly and genomically characterize patients with long term and short term disease control on olaparib in terms of:
    - Somatic BRCA mutation
    - Homologous recombination repair (HRR) deficiency panel
    - Genomic Sequencing
    - Immune Profile
    - PI3K/Akt pathway expression
    - Gene expression
    Caracterizar clínica, molecular y genómicamente a las pacientes con un control de la enfermedad a largo y corto plazo con olaparib en términos de lo siguiente:
    • Mutación de BRCA somática
    • Panel de deficiencia de reparación de recombinación homóloga (HRR)
    • Secuenciación genómica
    • Perfil inmunológico
    • Expresión de la vía PI3K/Akt
    • Expresión genética
    E.5.1.1Timepoint(s) of evaluation of this end point
    Estimated primary completion date: July 2019
    Julio 2019 (estimado)
    E.5.2Secondary end point(s)
    - To define the HRR deficiency profile
    - Define the level of poly (ADP-ribose) (PAR) expression by immunohistochemistry
    - To compare the signature of PARP response with the signature of platinum sensitivity which have been previously assessed in patient with long response to platinum based chemotherapy
    - To assess the signature of PARP response and PARP resistance on different tumour sites
    - To define how patient take olaparib in the long term setting

    Exploratory Endpoints
    - To characterize the tumor profile at disease progression
    - To assess the pharmacokinetics and pharmacogenomics of olaparib for patients still on treatment
    - To assess circulating tumor DNA (ctDNA) at the time of response on olaparib and at progression
    • Definir el perfil de déficit de HRR
    • Definir el nivel de expresión de poli ADP ribosa (PAR) mediante inmunohistoquímica
    • Comparar la firma de la respuesta de PARP con la firma de la sensibilidad de platino que se haya evaluado previamente en pacientes con una larga respuesta a quimioterapia basada en platino
    • Evaluar la firma de la respuesta de PARP y la resistencia a PARP en distintos sitios de tumores
    • Definir cómo los pacientes toman olaparib a largo plazo
    E.5.2.1Timepoint(s) of evaluation of this end point
    Estimated primary completion date: July 2019
    Julio 2019 (estimado)
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Prognosis
    Prognosis
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    E.8.1.7.1Other trial design description
    retrospectivo/prospectivo
    retrospective/prospective
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    pacientes con beneficio a corto plazo con Olaparib o que estan en tratamiento menos de 3 meses
    patients who had a short duration benefit with Olaparib or are in treatment less than 3 months
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    Canada
    Italy
    Spain
    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
    End of trial projected to be 4 years after initiation in July 2015 in Canada. This is a study involving patients from several clinical trials who had received olaparib. Sample size will not be based on any a priori considerations of statistical power, but rather on the number of available cases from the different studies.
    Fin del estudio sera 4 años despues de iniciado en Julio 2015 en Canada. Es un estudio en pacientes de varios estudios que han recibido Olaparib. El tamaño de la muestra no sera pre-definido pero se obtendra de los casos disponibles de distintos ensayos
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 100
    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 Decision2017-12-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-22
    P. End of Trial
    P.End of Trial StatusOngoing
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