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    Summary
    EudraCT Number:2019-001072-11
    Sponsor's Protocol Code Number:CO41012
    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:2019-07-05
    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 number2019-001072-11
    A.3Full title of the trial
    A PHASE IB/III STUDY OF IPATASERTIB PLUS PALBOCICLIB AND FULVESTRANT VERSUS PLACEBO PLUS PALBOCICLIB AND FULVESTRANT IN HORMONE RECEPTOR POSITIVE AND HER2 NEGATIVE LOCALLY ADVANCED UNRESECTABLE OR METASTATIC BREAST CANCER
    ESTUDIO DE FASE IB/III DE IPATASERTIB EN COMBINACIÓN CON PALBOCICLIB Y FULVESTRANT FRENTE A PLACEBO EN COMBINACIÓN CON PALBOCICLIB Y FULVESTRANT EN CÁNCER DE MAMA POSITIVO PARA RECEPTORES HORMONALES Y NEGATIVO PARA HER2 LOCALMENTE AVANZADO O METASTÁSICO INOPERABLE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer
    Un estudio de Ipatasertib Plus Palbociclib y Fulvestrant Versus Placebo Plus Palbociclib y Fulvestrant en Cáncer de mama positivo para receptores hormonales y negativo para HER2 localmente avanzado o metastásico inoperable
    A.4.1Sponsor's protocol code numberCO41012
    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 SponsorRoche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    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 number34913257300
    B.5.5Fax number34913248196
    B.5.6E-mailspain.start_up_unit@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 100 mg
    D.3.2Product code RO5532961
    D.3.4Pharmaceutical form Film-coated 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.3.9.2Current sponsor codeRO5532961
    D.3.9.4EV Substance CodeSUB189203
    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 200 mg
    D.3.2Product code RO5532961
    D.3.4Pharmaceutical form Film-coated 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.3.9.2Current sponsor codeRO5532961
    D.3.9.4EV Substance CodeSUB189203
    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.2.1.1.1Trade name Ibrance 75 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 INNPALBOCICLIB
    D.3.9.2Current sponsor codeRO4991855
    D.3.9.4EV Substance CodeSUB177204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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: 4
    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 Ibrance 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 INNPALBOCICLIB
    D.3.9.2Current sponsor codeRO4991855
    D.3.9.4EV Substance CodeSUB177204
    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: 5
    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 Ibrance 125 mg
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 INNPALBOCICLIB
    D.3.9.3Other descriptive namePalbociclib
    D.3.9.4EV Substance CodeSUB177204
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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: 6
    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 Faslodex
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFulvestrant
    D.3.9.3Other descriptive nameFULVESTRANT
    D.3.9.4EV Substance CodeSUB13933MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    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
    Hormone receptor (HR)-positive/HER2-negative locally advanced unresectable or metastatic breast cancer
    CÁNCER DE MAMA POSITIVO PARA RECEPTORES HORMONALES Y NEGATIVO PARA HER2 LOCALMENTE AVANZADO O METASTÁSICO
    E.1.1.1Medical condition in easily understood language
    HRs are found inside breast cells, HER2 is found on surface of breast cells. Cancers with detectable HR that do not have high levels of HER2 gene/HER2 protein are called HR-positive; HER2-negative
    Los RH se encuentran dentro de las cél mam, HER2 se encuentra en la superficie de las células mam. Los cánceres con HR detec q no tienen niveles altos de gen HER2/prot HER2 se llaman HR-positHER2 neg
    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 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 20.0
    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 evaluate the efficacy of ipatasertib + palbociclib + fulvestrant compared with placebo + palbociclib + fulvestrant in the intent to treat (ITT) population and in patients with PIK3CA/AKT1/PTEN altered tumors (Phase III)
    Evaluar la eficacia de ipatasertib + palbociclib + fulvestrant en comparación con placebo + palbociclib + fulvestrant por intención de tratar la población de ITT y en pacientes con presencia de alteraciones PIK3CA / AKT1 / PTEN (Fase III)
    E.2.2Secondary objectives of the trial
    1. To evaluate additional efficacy of ipatasertib + palbociclib + fulvestrant compared with placebo + palbociclib + fulvestrant in the ITT population and in patients with PIK3CA/AKT1/PTEN altered tumors (Phase III)
    2. To characterize the safety of combining ipatasertib with palbociclib + fulvestrant (Phase Ib and III)
    3. To characterize the Pharmacokinetic profiles of ipatasertib and its metabolite (G-037720) in combination with palbociclib and fulvestrant (Phase Ib and III)
    1.Los HR se encuentran dentro de las células mamarias, HER2 se encuentra en la superficie de las células mamarias. Los cánceres con HR detectable que no tienen niveles altos de gen HER2 / proteína HER2 se llaman HR-positivos; HER2 negativo
    2.Definir la seguridad de la combinación de ipatasertib con palbociclib +fulvestrant (Fase Ib y III)
    3.Definir los perfiles FC de ipatasertib y su metabolito (G-037720) en combinación con palbociclib y fulvestrant (Fase Ib y III)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >= 18 years
    - HR+ HER2- adenocarcinoma of the breast that is locally advanced unresectable or metastatic
    - For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs
    - For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm
    - Radiologic/objective relapse during adjuvant endocrine therapy or disease progression during the initial 12 months of 1L endocrine therapy in locally advanced unresectable or metastatic breast cancer
    - At least one measurable lesion via Response Evaluation Criteria in Solid Tumors, Version 1.1
    - Phase III only: Tumor specimen from the most recently collected, available tumor tissue
    -Tener >_18 años
    -Presentar adenocarcinoma de mama HR+, HER2-,documentado histológicamente, localmente avanzado o metastásico
    -Las mujeres potencialmente fértiles deben comprometerse a practicar la abstinencia sexual o a usar métodos anticonceptivos, así como a no donar óvulos
    -Los varones deben comprometerse a practicar la abstinencia sexual o a usar preservativos, así como a no donar semen
    -Los pacientes deben haber presentado evidencia radiológica/objetiva de recidiva durante los 12 primeros meses de terapia endocrina en primera línea (1L),en el contexto del cáncer de mama localmente avanzado o metastásico inoperable
    -Presentar al menos una lesión medible, de acuerdo con los criterios RECIST v1.1
    -Solo parte de fase III aleatorizada: muestra de tumor del tejido tumoral disponible
    E.4Principal exclusion criteria
    - Pregnant or breastfeeding, or intending to become pregnant
    - Prior treatment with fulvestrant or other selective estrogen receptor down-regulator
    - Prior treatment with PI3K inhibitor, mTOR inhibitor or AKT inhibitor
    - Phase Ib only: Prior treatment with CDK4/6 inhibitor
    - Prior treatment with a cytotoxic chemotherapy regimen for metastatic breast cancer
    - History of Type I or Type II diabetes mellitus requiring insulin
    - History of or active inflammatory bowel disease or active bowel inflammation
    - Lung disease: pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic infections
    -Mujeres embarazadas, o que tengan intención de quedarse embarazadas
    -Tratamiento previo con fulvestrant u otros SERD, independientemente del contexto en el que se haya administrado
    -Tratamiento previo con un inhibidor de CDK4/6,mTOR,o AKT
    -Solo pacientes de la fase Ib: Tratamiento previo con un inhibidor de CDK4/6
    - Tratamiento previo con un régimen de quimioterapia citotóxica para cáncer de mama metastásico
    -Antecedentes de diabetes mellitus de tipo I o II que requiera insulina
    -Antecedentes o presencia de enfermedades inflamatorias intestinales
    -Enfermedades pulmonares: neumonitis, enfermedad pulmonar intersticial, fibrosis pulmonar
    idiopática, fibrosis quística, aspergilosis, tuberculosis activa o antecedentes de infecciones oportunistas
    E.5 End points
    E.5.1Primary end point(s)
    1. Progression-free survival (PFS) in ITT patients
    2. PFS in patients with PIK3CA/AKT1/PTEN altered Tumors
    1. Supervivencia libre de progresión (SLP) en pacientes con ITT
    2. PFS en pacientes con tumores alterados PIK3CA / AKT1 / PTEN
    E.5.1.1Timepoint(s) of evaluation of this end point
    Phase III
    1-2. Up to 64 months
    Fase III
    1-2. Hasta 64 meses
    E.5.2Secondary end point(s)
    Phase III
    1. Objective response rate (ORR)
    2. Duration of objective response (DOR)
    3. Clinical benefit rate (CBR)
    4. Overall survival (OS)
    5. Time to deterioration (TTD) in pain
    6. TTD in physical functioning, role functioning, and Global Health Survey/Health-Related Quality of Life

    Phase Ib and III
    7. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0
    8. Change from baseline in targeted vital signs
    9. Change from baseline in targeted clinical laboratory test results
    10. Plasma concentration of ipatasertib and its metabolite, G-037720, at specified timepoints
    Fase III
    1. Tasa de respuesta objetiva (ORR)
    2. Duración de la respuesta objetiva (DOR)
    3. Tasa de beneficio clínico (CBR)
    4. Supervivencia global (OS)
    5. Tiempo de deterioro (TTD) en el dolor.
    6. TTD en funcionamiento físico, función de rol y Encuesta de salud global / Calidad de vida relacionada con la salud

    Fase Ib y III
    7. Incidencia y gravedad de los eventos adversos, y la gravedad se determina de acuerdo con los Criterios de Terminología Comunes para Eventos Adversos del National Cancer Institute, Versión 5.0
    8. Cambio desde la línea de base en signos vitales específicos.
    9. Cambio desde el inicio en los resultados de las pruebas de laboratorio clínico dirigidas.
    10. Concentración de plasma de ipatasertib y su metabolito, G-037720, en puntos de tiempo especificados
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-9. Up to 64 months
    10. Phase Ib: Cycle 1 Day 1 and 15; Cycle 2 and 3 Day 15; Phase III: Cycle 1 Day 1 and 15; Cycle 2 Day 15
    1-9. Hasta 64 meses
    10. Fase Ib: Ciclo 1 Día 1 y 15; Ciclo 2 y 3 Día 15; Fase III: Ciclo 1 Día 1 y 15; Ciclo 2 Día 15
    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 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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Ib
    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 Yes
    E.8.1.7.1Other trial design description
    with open-label phase Ib portion
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Australia
    Brazil
    Canada
    Japan
    Korea, Republic of
    Spain
    United Kingdom
    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
    LPLV but the Sponsor may decide to terminate the study or OS follow-up at any time
    LPLV pero el Promotor puede decidir terminar el estudio o el seguimiento de la SG en cualquier momento
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months4
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 170
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 370
    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)
    Currently, the Sponsor does not have any plans to provide the Roche IMP (ipatasertib) or any other study treatments or interventions to patients who have completed the study.
    Actualmente, el Promotor no tiene planes de proporcionar Roche IMP (ipatasertib) ni ningún otro tratamiento o intervención del estudio a los pacientes que hayan completado el estudio
    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 Decision2019-08-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-21
    P. End of Trial
    P.End of Trial StatusCompleted
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