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    Summary
    EudraCT Number:2020-000119-66
    Sponsor's Protocol Code Number:BO41843
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-03
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-000119-66
    A.3Full title of the trial
    A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF GDC-9545 COMBINED WITH PALBOCICLIB COMPARED WITH LETROZOLE COMBINED WITH PALBOCICLIB IN PATIENTS WITH ESTROGEN RECEPTOR-POSITIVE, HER2-NEGATIVE LOCALLY ADVANCED OR METASTATIC BREAST CANCER
    STUDIO DI FASE III, RANDOMIZZATO, IN DOPPIO CIECO, CONTROLLATO CON PLACEBO E MULTICENTRICO VOLTO A VALUTARE L’EFFICACIA E LA SICUREZZA DI GDC-9545 IN ASSOCIAZIONE A PALBOCICLIB RISPETTO A LETROZOLO IN ASSOCIAZIONE A PALBOCICLIB IN PAZIENTI CON TUMORE MAMMARIO POSITIVO PER IL RECETTORE DEGLI ESTROGENI E HER2-NEGATIVO, LOCALMENTE AVANZATO O METASTATICO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Efficacy and Safety of GDC-9545 Combined with Palbociclib Compared with Letrozole Combined with Palbociclib in Patients with Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
    Questo studio valuterà l’efficacia e la sicurezza di GDC-9545 in associazione a palbociclib rispetto a letrozolo in associazione a palbociclib in pazienti con tumore mammario positivo per il recettore degli estrogeni (ER-positivo) e HER2 negativo, localmente avanzato (recidivante o andato incontro a progressione) o metastatico
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code numberBO41843
    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 SponsorF. 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 number000000
    B.5.5Fax number000000
    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 nameGDC-9545
    D.3.2Product code [Ro 719-7597/F12-01]
    D.3.4Pharmaceutical form Capsule
    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 INNNAP
    D.3.9.2Current sponsor codeRO7197597
    D.3.9.4EV Substance CodeSUB194747
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 RoleComparator
    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 nameLetrozole
    D.3.2Product code [RO 489-7779 /F01-01]
    D.3.4Pharmaceutical form Capsule
    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 INNLETROZOLE
    D.3.9.1CAS number 112809-51-5
    D.3.9.2Current sponsor codeRO 489-7779 /F01-01
    D.3.9.4EV Substance CodeSUB08444MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2500
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 RoleComparator
    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
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG EU/1/16/1147/001
    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.3.1Product nameIbrance
    D.3.2Product code [palbociclib]
    D.3.4Pharmaceutical form Capsule
    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 codeRo 499-1855
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 RoleComparator
    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
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG EU/1/16/1147/003
    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.3.1Product nameIbrance
    D.3.2Product code [palbociclib]
    D.3.4Pharmaceutical form Capsule
    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 codeRo- 499-1855
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 RoleComparator
    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
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG - EU/1/16/ 1147/005
    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.3.1Product nameIbrance
    D.3.2Product code [PALBOCICLIB]
    D.3.4Pharmaceutical form Capsule
    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 codeRo 499-1855
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 placeboCapsule
    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 placeboCapsule
    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
    Estrogen receptor (ER)-positive, HER2-negative locally advanced or metastatic breast cancer
    Tumore mammario positivo per il recettore degli estrogeni e HER2 negativo, localmente avanzato o metastatico
    E.1.1.1Medical condition in easily understood language
    Breast cancer begins when abnormal cancerous cells in the breast grow and multiply to create a tumor. This tumor can be ER-positive, HER2-negative
    Il cancro al seno inizia quando le cellule cancerose anormali nel seno crescono e si moltiplicano per creare un tumore. Questo tumore può essere ER-positivo, HER2-negativo
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10070575
    E.1.2Term Estrogen receptor positive breast cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.0
    E.1.2Level LLT
    E.1.2Classification code 10070577
    E.1.2Term Oestrogen receptor positive 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 10027475
    E.1.2Term Metastatic 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 GDC-9545 combined with palbociclib compared with letrozole combined with palbociclib on the basis of progression-free survival
    -Valutare l’efficacia di GDC-9545 in associazione a palbociclib rispetto a letrozolo in associazione a palbociclib sulla base della sopravvivenza libera da progressione
    E.2.2Secondary objectives of the trial
    -To evaluate the efficacy of GDC-9545 combined with palbociclib compared with letrozole combined with palbociclib on the basis of overall survival, objective response rate, duration of response, clinical benefit rate, time to deterioration, time to deterioration in pain presence and interference, time to deterioration in physical functioning, time to deterioration in role functioning, time to deterioration in global health status
    -To evaluate the safety of GDC-9545 combined with palbociclib compared with letrozole combined with palbociclib
    -To characterize the GDC-9545 pharmacokinetics profile when given in combination with palbociclib
    -To characterize the palbociclib pharmacokinetics profile when given in combination with GDC-9545 or in combination with letrozole
    -Valutare l’efficacia di GDC-9545 in associazione a palbociclib rispetto a letrozolo in associazione a palbociclib sulla base della sopravvivenza globale, tasso di risposta obiettiva, durata della risposta, Tasso di beneficio clinico, tempo al peggioramento, tempo al peggioramento della presenza e dell’interferenza del dolore, tempo al peggioramento dell’attività fisica, tempo al peggioramento del funzionamento nel ruolo, tempo al peggioramento delle condizioni generali di salute
    -Valutare la sicurezza di GDC-9545 in associazione a palbociclib rispetto a letrozolo in associazione a palbociclib
    -Caratterizzare il profilo PK di GDC-9545 somministrato in associazione a palbociclib
    -Caratterizzare il profilo PK di palbociclib somministrato in associazione a GDC 9545 o in associazione a letrozolo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    –Age >= 18 years at time of signing Informed Consent Form
    –For women who are premenopausal or perimenopausal or men: treatment with approved LHRH agonist therapy for the duration of study treatment
    –Locally advanced (recurrent or progressed) or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
    –Documented ER-positive tumor and HER2-negative tumor, assessed locally
    –No history of systemic anti-cancer therapy for locally advanced (recurrent or progressed) or metastatic disease
    –Measurable disease as defined per RECIST v.1.1
    –Eastern Cooperative Oncology Group Performance Status 0-1
    –Adequate organ function
    - Età >=18 anni al momento della sottoscrizione del modulo di consenso informato
    - Per le donne in stato postmenopausale o premenopausale o uomini: trattamento con una terapia a base di agonista dell’LHRH approvata per l’intera durata del trattamento in studio
    - Adenocarcinoma mammario localmente avanzato (recidivante o andato incontro a progressione) o metastatico non candidabile a trattamento con intento curativo
    - Tumore ER-positivo documentato e tumore HER2-negativo valutato localmente
    - Nessuna terapia antitumorale sistemica pregressa per malattia localmente avanzata (recidivante o andata incontro a progressione) o metastatica.
    - Malattia misurabile secondo i criteri RECIST v.1.1.
    - Performance status secondo l’Eastern Cooperative Oncology Group pari a 0-1.
    - Adeguata funzionalità d’organo
    E.4Principal exclusion criteria
    –Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with an AI
    –Disease recurrence during or within 12 months of completing prior neoadjuvant or adjuvant treatment with any CDK4/6 inhibitor
    –Prior treatment with a SERD
    –Prior treatment with tamoxifen is permitted, provided the patient did not experience disease recurrence within the first 24 months of treatment with tamoxifen
    –Treatment with any investigational therapy within 28 days prior to study treatment
    –Advanced, symptomatic, visceral spread that is at risk of life-threatening complications
    –Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease
    –Active cardiac disease or history of cardiac dysfunction
    –Pregnant or breastfeeding
    -Recidiva della malattia durante o entro 12 mesi dal completamento del precedente trattamento neoadiuvante o adiuvante con un inibitore dell’aromatasi
    - Recidiva della malattia durante o entro 12 mesi dal completamento del precedente trattamento neoadiuvante o adiuvante con qualsiasi inibitore delle chinasi ciclina-dipendente 4/6
    - Precedente trattamento con un degradatore selettivo dei recettori degli estrogeni
    - È ammesso il precedente trattamento con tamoxifene, a condizione che il paziente non abbia manifestato recidiva della malattia entro i primi 24 mesi del trattamento con tamoxifene
    - Trattamento con qualsiasi terapia sperimentale nei 28 giorni precedenti il trattamento in studio
    - Diffusione viscerale sintomatica avanzata a rischio di complicanze potenzialmente letali
    - Metastasi attive note non controllate o sintomatiche a carico del sistema nervoso centrale
    - Malattia cardiaca attiva o anamnesi positiva per disfunzione cardiaca
    - Gravidanza o allattamento
    E.5 End points
    E.5.1Primary end point(s)
    1. Progression-free survival as determined by the investigator
    1. Sopravvivenza libera da progressione determinata dallo sperimentatore
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Approximately 82 months
    1. Circa 82 mesi
    E.5.2Secondary end point(s)
    Efficacy
    1. Overall survival
    2. Objective response rate as determined by the investigator
    3. Duration of response as determined by the investigator
    4. Clinical benefit rate as determined by the investigator
    5. Time to deterioration in pain level
    6. Time to deterioration in pain presence and interference, in physical functioning, in role functioning, and in global health status
    7. Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0
    8. Change from baseline in targeted vital signs
    9. Plasma concentration of GDC-9545 at specified timepoints
    10. Plasma concentration of palbociclib at specified timepoints
    Efficacia
    1. Sopravvivenza globale
    2. Tasso di risposta obiettiva secondo quanto stabilito dallo sperimentatore
    3. Durata della risposta secondo quanto stabilito dallo sperimentatore
    4. Tasso di beneficio clinic secondo quanto stabilito dallo sperimentatore
    5. Tempo al peggioramento del livello di dolore
    6. Tempo al peggioramento della presenza e dell’interferenza del dolore dell’attività fisica, del funzionamento nel ruolo e delle condizioni generali di salute
    7. Incidenza e severità degli eventi avversi, con severità stabilita in base ai criteri comuni di terminologia per gli eventi avversi del National Cancer Institute (NCI), versione 5.0 (CTCAE v5.0)
    8. Variazione dei parametri vitali di interesse rispetto al basale
    9. Concentrazione plasmatica di GDC-9545 a specifici timepoint
    10. Concentrazione plasmatica di palbociclib a specifici timepoint
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-7. Approximately 82 months
    8. From baseline (Day-28 to -1) to 82 months
    9. Day 1 and 15 of Cycle 1, Day 1 of Cycle 2, 4, 8, and 16 and at treatment discontinuation
    10. Day 1 and 15 of Cycle 1
    1-7. Circa 82 mesi
    8. Dal basale (giorno -28 al -1) a 82 mesi
    9. Giorno 1 e 15 del ciclo 1, giorno 1 del ciclo 2, 4, 8, e 16 e ad interruzione del trattamento
    10. Giorno 1 e 15 del ciclo 1
    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 Yes
    E.6.13.1Other scope of the trial description
    Biomarkers
    Biomarcatori
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group 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) Yes
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA118
    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 Information not present in EudraCT
    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
    China
    Hong Kong
    Korea, Republic of
    Mexico
    New Zealand
    Peru
    South Africa
    Turkey
    Ukraine
    United States
    Belgium
    Denmark
    France
    Germany
    Hungary
    Italy
    Poland
    Portugal
    Spain
    Switzerland
    United Kingdom
    Argentina
    Greece
    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
    The end of this study (global phase and China extension phase) is defined as the date when the last patient, last visit occurs or the date at which the last data point required for statistical analysis or overall survival follow-up is received from the last patient, whichever occurs later. The end of the study is expected to occur at least 60 months after the last patient is enrolled. In addition, the Sponsor may decide to terminate the study at any time.
    La fine dello studio (fase globale e fase di estensione cinese) coinciderà con la data in cui si terrà l’ultima visita dell’ultimo paziente o con la data di ricezione dell’ultima osservazione relativa all’ultimo paziente necessaria per l’analisi statistica o il follow up per la sopravvivenza globale. Lo studio dovrebbe terminare almeno 60 mesi dopo l’arruolamento dell’ultimo paziente. Il promotore potrà inoltre decidere di interrompere lo studio in qualsiasi momento.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months82
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months82
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 391
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 587
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 295
    F.4.2.2In the whole clinical trial 978
    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 Genentech IMP GDC-9545 or any other study treatments or interventions to patients who have completed the study. The Sponsor may evaluate whether to continue providing GDC-9545 in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, available at the following website: http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    Attualmente, lo Sponsor non ha in programma di fornire Genentech IMP GDC-9545 o altri trattamenti o interventi di studio ai pazienti che hanno completato lo studio. Lo Sponsor può valutare se continuare a fornire GDC-9545 in conformità con la Roche Global Policy sull'accesso continuo al prodotto medicinale sperimentale, disponibile sul seguente sito Web:
    http://www.roche.com/policy_continued_access_to_ivestigational_medicines.pdf
    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 Decision2020-11-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-06
    P. End of Trial
    P.End of Trial StatusOngoing
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