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    Summary
    EudraCT Number:2014-000469-35
    Sponsor's Protocol Code Number:GO29227
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-08-06
    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 number2014-000469-35
    A.3Full title of the trial
    A RANDOMIZED, PHASE II, MULTICENTER, PLACEBO-CONTROLLED STUDY OF IPATASERTIB (GDC-0068), AN INHIBITOR OF AKT, IN COMBINATION WITH PACLITAXEL AS FRONT-LINE TREATMENT FOR PATIENTS WITH METASTATIC TRIPLE-NEGATIVE BREAST CANCER.
    ESTUDIO ALEATORIZADO, DE FASE II, MULTICÉNTRICO Y
    CONTROLADO CON PLACEBO DE IPATASERTIB (GDC-0068), UN INHIBIDOR DE AKT, EN COMBINACIÓN CON PACLITAXEL COMO TRATAMIENTO DE PRIMERA LÍNEA EN PACIENTES CON CÁNCER DE MAMA TRIPLE NEGATIVO METASTÁSICO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized phase II study assessing the safety and efficacy of ipatasertib in patients with breast cancer that has spread beyond the initial site, without certain hormonal receptors.
    ESTUDIO ALEATORIZADO DE FASE II QUE EVALUA LA SEGURIDAD Y EFICACIA DE IPATASERTIB EN PACIENTES CON CÁNCER DE MAMA QUE SE HA DISEMINADO MÁS ALLA DEL SITIO INICIAL, SIN CIERTOS RECEPTORES HORMONALES
    A.4.1Sponsor's protocol code numberGO29227
    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 SponsorGenentech, 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 supportGenentech Inc. c/o F. Hoffmann La Roche Ltd.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenentech Inc. c/o F. Hoffmann La Roche Ltd.
    B.5.2Functional name of contact pointTrial Inform Support -Marta Maislan
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number-913257300-
    B.5.5Fax number----
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 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 nameipatasertib
    D.3.2Product code GDC-0068 100mg
    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 INNipatasertib
    D.3.9.3Other descriptive nameRO5532961
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 2
    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 nameipatasertib
    D.3.2Product code GDC-0068 200mg
    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 INNipatasertib
    D.3.9.3Other descriptive nameRO5532961
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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.IMP: 3
    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.2.5The 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 Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Inoperable locally advanced or metastatic triple negative breast cancer
    cancer de mama triple negativo metastásico o avanzado inoperable
    E.1.1.1Medical condition in easily understood language
    Breast cancer that has spread beyond the initial site, without certain hormonal receptors.
    cáncer de mama que se ha diseminado más allá del sitio inicial, sin ciertos receptores hormonales.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10027475
    E.1.2Term Metastatic breast cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10072740
    E.1.2Term Locally advanced breast cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To estimate the efficacy of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in patients with inoperable locally advanced or metastatic triple negative breast cancer (mTNBC), as measured by progression free survival (PFS) in all patients and in patients with PTEN low tumors
    El objetivo de eficacia principal de este estudio es evaluar la eficacia del ipatasertib combinado
    con paclitaxel, en comparación con un placebo combinado con paclitaxel, en pacientes con
    cáncer de mama triple negativo metastásico (CMTNm) o localmente avanzado e inoperable,
    determinada mediante la supervivencia sin progresión (SSP) en todas las pacientes y en las
    pacientes con tumores con PTEN bajo
    E.2.2Secondary objectives of the trial
    - To estimate the clinical activity, as measured by overall survival (OS), objective response rate (ORR), and duration of objective tumor response of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in all patients and in patients with PTEN low tumors.
    - To estimate the clinical activity, as measured by PFS, OS, ORR, and duration of objective tumor response, of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in patients who are Akt diagnostic positive (Dx+) (defined by PTEN status, INPP4B status, and PI3K alterations)
    - Calcular la actividad clínica, determinada por la supervivencia global (SG), la tasa de
    respuestas objetivas (TRO) y duración de la respuesta tumoral objetiva, del ipatasertib
    combinado con paclitaxel, en comparación con un placebo combinado con paclitaxel, en
    todas las pacientes y en las pacientes con tumores con PTEN bajo.
    - Calcular la actividad clínica, determinada mediante la SSP, la SG, la TRO y la duración de
    la respuesta tumoral objetiva, del ipatasertib combinado con paclitaxel, en comparación con
    un placebo combinado con paclitaxel, en pacientes con diagnóstico de Akt positivo (Dx+)
    (definido por el estado de PTEN, el estado de INPP4B y las alteraciones de PI3K)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed Informed Consent Form,
    - Premenopausal or postmenopausal women age above or equal to 18 years,
    - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1,
    - Histologically documented triple negative adenocarcinoma of the breast that is inoperable locally advanced or metastatic and is not amenable to resection with curative intent,
    - Availability of a representative formalin fixed, paraffin embedded (FFPE) tumor specimen that enables a diagnosis of triple negative adenocarcinoma of the breast, accompanied by an associated pathology report, for central molecular analysis (required prior to randomization),
    - Measurable disease, according to RECIST v1.1,
    - Adequate hematologic and organ function within 14 days before the first study treatment,
    - For female patients of childbearing potential, agreement (by both patient and partner) to use an effective form of contraception).
    ?Documento de consentimiento informado (DCI) firmado.
    ?Mujeres premenopáusicas o posmenopáusicas de edad ? 18 años
    ?Estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0 o 1
    ?Adenocarcinoma de mama triple negativo confirmado por histología, que sea inoperable, localmente avanzado o metastásico y no sea susceptible de resección con intención curativa
    ?Disponibilidad de una muestra tumoral representativa fijada en formol e incluida en parafina (FFIP), que permita hacer un diagnóstico de adenocarcinoma de mama triple negativo, acompañada de un informe anatomopatológico, para análisis molecular central (obligatorio antes de la aleatorización)
    ?Enfermedad mensurable con arreglo a los criterios RECIST v1.1
    ?Función hematológica y orgánica adecuada en los 14 días previos al comienzo del tratamiento del estudio
    ?Para pacientes en edad fértil o periodo de lactancia, compromiso (por parte de la paciente y su pareja) a utilizar un método anticonceptivo eficaz
    E.4Principal exclusion criteria
    - Any previous therapy, including chemotherapy or hormonal or targeted therapy, for inoperable locally advanced or metastatic triple negative adenocarcinoma of the breast;
    - Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1;
    - Known HER2 positive, ER positive, or PR positive breast cancer;
    - Previous therapy with Akt, PI3K, and/or mTOR inhibitors;
    - Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study;
    - Known presence of the brain or spinal cord metastasis;
    - Need for chronic corticosteroid therapy of 10 mg or more of prednisone per day or an equivalent dose of other anti inflammatory corticosteroids or immunosuppressants for a chronic disease;
    - Known hypersensitivity or contraindication to any component of the study treatments, including paclitaxel excipient macrogolglycerol ricinoleate;
    - Grade equal or above 2 peripheral neuropathy;
    - History of Type I or Type II diabetes mellitus requiring insulin;
    - New York Heart Association (NYHA) Class II, III, or IV heart failure, or left ventricular ejection fraction < 50%, or active ventricular arrhythmia requiring medication;
    - Current unstable angina or history of myocardial infarction within 6 months prior to Cycle 1, Day 1;
    - Grade equeal or above 2 uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia;
    - Congenital long QT syndrome or screening corrected QT interval (QTc) above 480 milliseconds;
    - Bisphosphonate therapy for currently symptomatic hypercalcemia;
    - History of malabsorption syndrome, lack of physical integrity of the upper gastrointestinal tract, or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills;
    - Active infection requiring intravenous (IV) antibiotics;
    - Known clinically significant history of liver disease consistent with Child Pugh Class B or C, including active viral or other hepatitis (e.g., Hepatitis B or Hepatitis C virus), current alcohol abuse, or cirrhosis;
    - Known human immunodeficiency virus (HIV) infection;
    - Pregnancy, lactation, or breastfeeding;
    - Inability to comply with study and follow up procedures;
    - Malignancies other than TNBC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, ductal carcinoma in situ treated surgically with curative intent);
    - Unresolved, clinically significant toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy;
    - Active small or large intestine inflammation (such as Crohn?s disease or ulcerative colitis);
    - Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator?s opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications.
    -Cualquier tratamiento previo, incluidos la quimioterapia y el tratamiento hormonal o dirigido, para el adenocarcinoma de mama triple negativo inoperable, localmente avanzado o metastásico.
    -Radioterapia de un foco metastásico en los 28 días anteriores al día 1 del ciclo 1
    -Cáncer de mama HER2-positivo, RE-positivo o RP-positivo.
    -Tratamiento previo con inhibidores de Akt, PI3K o mTOR
    -Intervención de cirugía mayor, biopsia abierta o traumatismo importante en los 30 días previos al día 1 del ciclo 1 o previsión de la necesidad de una intervención de cirugía mayor durante el estudio
    -Presencia conocida de metástasis cerebrales o de la médula espinal
    -Necesidad de tratamiento crónico con corticosteroides en una dosis ? 10 mg de prednisona al día o una dosis equivalente de otros corticosteroides antiinflamatorios o inmunodepresores por una enfermedad crónica
    -Hipersensibilidad o contraindicación conocidas a alguno de los componentes de los fármacos del estudio, incluido el excipiente del paclitaxel, el ricinoleato de macrogolglicerol
    -Neuropatía periférica de grado ? 2.
    -Antecedentes de diabetes mellitus de tipo 1 o 2 con necesidad de insulina.
    -Insuficiencia cardíaca de clase II, III, o IV de la New York Heart Association (NYHA) véase el Apéndice 6) o fracción de eyección ventricular izquierda < 50 % o arritmia ventricular activa con necesidad de medicación
    -Angina inestable actual o antecedentes de infarto de miocardio durante los 6 meses previos al día 1 del ciclo 1.
    -Hipercolesterolemia o hipertrigliceridemia de grado ? 2 no controlada o no tratada
    -Síndrome de QT largo congénito o intervalo QT corregido (QTc) > 480 milisegundos durante la selección.
    -Tratamiento con bisfosfonatos para la hipercalcemia sintomática actual
    -Antecedentes de síndrome de malabsorción, ausencia de integridad física del aparato digestivo alto o cualquier otro trastorno que pueda interferir en la absorción intestinal o provocar incapacidad o falta de disposición a tragar comprimidos
    -Infección activa con necesidad de antibióticos intravenosos
    -Antecedentes clínicamente significativos de hepatopatía compatible con una clase B o C de Child-Pugh, incluidas las hepatitis víricas o de otro tipo (por ejemplo, virus de la hepatitis B o C), alcoholismo activo o cirrosis.
    -Infección conocida por el virus de la inmunodeficiencia humana (VIH).
    -Embarazo o lactancia.
    -Incapacidad para cumplir los procedimientos del estudio o del seguimiento
    -Tumores malignos distintos del CMTN en los 5 años anteriores al día 1 del ciclo 1, excepto los que tienen un riesgo insignificante de metástasis o muerte (como el carcinoma in situ del cuello uterino debidamente tratado, el cáncer cutáneo basocelular o epidermoide o el carcinoma ductal in situ tratado quirúrgicamente con intención curativa).
    -Toxicidad clínicamente importante no resuelta de un tratamiento previo, excepto alopecia y neuropatía periférica de grado 1
    -Inflamación activa del intestino delgado o grueso (como enfermedad de Crohn o colitis ulcerosa).
    -Cualquier otra enfermedad, disfunción metabólica, hallazgo en la exploración física o resultado analítico que, en opinión del investigador, suscite sospechas razonables de una enfermedad o proceso que contraindique el uso de un fármaco en investigación o que pueda afectar a la interpretación de los resultados o suponer un riesgo elevado de complicaciones del tratamiento para el paciente
    E.5 End points
    E.5.1Primary end point(s)
    PFS, defined as the time from randomization to the first occurrence of disease progression, as determined by investigator review of tumor assessments by RECIST, v1.1 or death on study (less or equal to 30 days after the last dose of study treatment regimen) from any cause, whichever occurs first
    SSP, que se define como el tiempo transcurrido desde la aleatorización hasta el primer episodio de progresión de la enfermedad (determinada mediante los criterios de evaluación de la respuesta por RECIST, v1.1 y por la evaluación del investigador) o hasta la muerte durante el estudio por cualquier causa (en los 30 días siguientes a la última dosis del régimen de tratamiento del estudio, lo que ocurra primero
    E.5.1.1Timepoint(s) of evaluation of this end point
    There will be an interim safety analyses after the first 20 patients have completed two treatment cycles and an interim efficacy analysis after a total of approximately 40 PFS events have occurred. The primary analysis is expected to be triggered at 50 PFS events in patients with PTEN low tumors at approximately 24 months after enrollment of the first patient.
    Habrá un análisis de seguridad intermedio después de que los primeros 20 pacientes hayan completado dos ciclos de tratamiento y un análisis intermedio de eficacia después de que se hayan producido un total de aproximadamente 40 eventos de PFS. Se espera que el análisis principal se active en 50 eventos de SLP en los pacientes con tumores de bajo PTEN en aproximadamente 24 meses después de la inclusión del primer paciente
    E.5.2Secondary end point(s)
    Overall survival (OS), confirmed tumor response rate by RECIST, v1.1, and duration of confirmed tumor response by RECIST, v1.1
    Supervivencia global (SG), confirmada por grado de respuesta al tumor por RECIST, v 1.1, y duración de la respuesta al tumor confirmada por RECIST v1.1
    E.5.2.1Timepoint(s) of evaluation of this end point
    There will be an interim safety analyses after the first 20 patients have completed two treatment cycles and an interim efficacy analysis after a total of approximately 40 PFS events have occurred. The primary analysis is expected to be triggered at 50 PFS events in patients with PTEN low tumors at approximately 24 months after enrollment of the first patient
    Habrá un análisis de seguridad intermedio después de que los primeros 20 pacientes hayan completado dos ciclos de tratamiento y un análisis intermedio de eficacia después de que se hayan producido un total de aproximadamente 40 eventos de PFS. Se espera que el análisis principal se active en 50 eventos de SLP en los pacientes con tumores de bajo PTEN en aproximadamente 24 meses después de la inclusión
    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 Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Tolerabilidad
    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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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
    France
    Italy
    Korea, Republic of
    Singapore
    Spain
    Taiwan
    United States
    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
    Ultima visita del ultimo paciente
    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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    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: 90
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state24
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 120
    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 Sponsor may offer post-trial access to ipatasertib, free of charge to eligible patients if all of the following conditions are met:
    ? The patient has a life-threatening or severe medical condition and requires continued study drug treatment for his or her well-being
    ? There are no appropriate alternative treatments available to the patient
    ? The patient and his or her doctor comply with and satisfy any legal or regulatory requirements that apply to them
    El promotor puede ofrecer acceso a ipatasertib tras el ensayo, de forma gratuita a los pacientes elegibles si se dan las condiciones siguientes:
    -El paciente tiene una condición médica potencialmente mortal o grave y requiere tratamiento continuado del fármaco de estudio para su bienestar
    -No hay tratamientos alternativos adecuados disponibles
    -El paciente y su médico cumplen con requisitos legales y regulatorios que apliquen
    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 Decision2014-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-08-31
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