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Uno studio per saperne di più su come funziona il trattamento con le compresse BAY2927088 e quanto è sicuro nei partecipanti che hanno un tumore solido con mutazioni del recettore 2 del fattore di crescita epidermico umano (HER2) (panSOHO)

2 novembre 2026 aggiornato da: Bayer

Uno studio di fase 2 in aperto per valutare l'efficacia e la sicurezza dell'inibitore reversibile della tirosina chinasi BAY 2927088 somministrato per via orale in partecipanti con tumori solidi metastatici o non resecabili con mutazioni attivanti HER2

Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.

In this trial, the researchers want to learn how well BAY2927088 (sevabertinib) works in people with different types of solid tumors with HER2 mutations. These include tumors in the colon or rectum, the uterus and the cervix (lower part of the uterus), the breast, the bladder, and the biliary tract (includes gall bladder and bile ducts) as well as other types of solid tumors with the exception of people with advanced non-small cell lung cancer (NSCLC).

Solid tumors may have specific changes or mutations to a gene called human epidermal growth receptor-2 (HER2). This leads to the formation of an abnormal form of HER2 protein in the cancer cells, resulting in increased cell growth. The study treatment, BAY2927088, is expected to block the abnormal HER2 protein which may stop the spread of cancer.

The trial will include about 111 participants who are at least 18 years old. All the participants will take 20 mg of BAY2927088 as tablets by mouth.

The participants will take treatments in 3-week periods called cycles. These 3-week cycles will be repeated throughout the trial. The participants can take BAY2927088 until their cancer gets worse, until they have medical problems, or until they leave the trial.

During the trial, the doctors will take imaging scans of different parts of the body to study the spread of cancer and will check heart health using echocardiogram or cardiac magnetic resonance imaging (MRI) and electrocardiogram (ECG). The doctors will also take blood and urine samples and do physical examinations to check the participants' health. They will ask questions about how the participants are feeling and if they have any medical problems.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

111

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Reclutamento
        • NSW Health - Blacktown Hospital
      • Sydney, New South Wales, Australia, 2109
        • Reclutamento
        • Macquarie University Hospital - Oncology Department
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Non ancora reclutamento
        • ICON Cancer Centre - Southport
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Ritirato
        • Queen Elizabeth II Health Sciences Centre | Oncology
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Reclutamento
        • Princess Margaret Cancer Centre | Medical Oncology and Hematology
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Ritirato
        • Research Institute of the McGill University Health Centre | Women Health's Research Unit
  • Cina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina, 100142
        • Reclutamento
        • Beijing Cancer Hospital - Oncology Department
      • Beijing, Beijing Municipality, Cina, 100034
        • Reclutamento
        • Peking University First Hospital - Oncology Department
    • Hunan
      • Changsha, Hunan, Cina, 410013
        • Non ancora reclutamento
        • Hunan Cancer Hospital - Oncology Department
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Cina, 200000
        • Reclutamento
        • Fudan University Shanghai Cancer Center - Oncology Department
      • Shanghai, Shanghai Municipality, Cina, 200032
        • Reclutamento
        • Zhongshan Hospital, Fudan University
    • Zhejiang
      • Hangzhou, Zhejiang, Cina, 310016
        • Non ancora reclutamento
        • Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
  • Corea del Sud
      • Seoul, Corea del Sud, 05505
        • Reclutamento
        • Asan Medical Center | Oncology
      • Seoul, Corea del Sud, 03722
        • Reclutamento
        • Severance Hospital | Oncology
      • Seoul, Corea del Sud, 06351
        • Reclutamento
        • Samsung Medical Center | Oncology
    • Seoul
      • Jongno -Gu, Seoul, Corea del Sud, 03080
        • Attivo, non reclutante
        • Seoul National University Hospital | Oncology
  • Danimarca
    • Capital Region / Region Hovedstaden
      • Copenhagen, Capital Region / Region Hovedstaden, Danimarca, 2100
        • Reclutamento
        • Rigshospitalet Copenhagen University Hospital | Oncology Department
    • Central Denmark Region / Region Midtjylland
      • Aarhus N, Central Denmark Region / Region Midtjylland, Danimarca, 8200
        • Ritirato
        • Aarhus University Hospital | Oncology Department - Clinical Research Unit
    • Region of Southern Denmark / Region Syddanmark
      • Odense, Region of Southern Denmark / Region Syddanmark, Danimarca, 5000
        • Reclutamento
        • Odense University Hospital | Svendborg Sygehus - Oncology Department
  • Francia
    • Auvergne-Rhône-Alpes
      • Pierre-Bénite, Auvergne-Rhône-Alpes, Francia, 69310
        • Reclutamento
        • Centre Hospitalier Lyon Sud - Service oncologie medicale
    • Brittany Region
      • Brest, Brittany Region, Francia, 29200
        • Reclutamento
        • CHU Brest - Hopital La Cavale Blanche - service oncologie medicale
    • Hauts-de-France
      • Lille, Hauts-de-France, Francia, 59000
        • Non ancora reclutamento
        • Centre Oscar Lambret - Service Oncologie
    • New Aquitaine
      • Bordeaux, New Aquitaine, Francia, 33000
        • Reclutamento
        • Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale
    • Occitanie
      • Montpellier, Occitanie, Francia, 34298
        • Non ancora reclutamento
        • ICM - Institut du Cancer de Montpellier - Val d'Aurelle - CIPP
    • Île-de-France Region
      • Villejuif, Île-de-France Region, Francia, 94805
        • Reclutamento
        • Institut Gustave Roussy - Departement d'Innovation Therapeutique et d'Essais Precoces (DITEP)
  • Giappone
    • Aichi-ken
      • Nagoya, Aichi-ken, Giappone, 464-8681
        • Reclutamento
        • Aichi Cancer Center Hospital
    • Chiba
      • Kashiwa, Chiba, Giappone, 277-8577
        • Reclutamento
        • National Cancer Center Hospital East (NCCHE) - Kashiwa Campus
    • Hokkaido
      • Sapporo, Hokkaido, Giappone, 060-8648
        • Reclutamento
        • Hokkaido University Hospital
    • Osaka
      • Sakai, Osaka, Giappone, 590-0197
        • Reclutamento
        • Kindai University Hospital
    • Tokyo
      • Chuo-ku, Tokyo, Giappone, 104-0045
        • Reclutamento
        • National Cancer Center Hospital
      • Koto-ku, Tokyo, Giappone, 135-8550
        • Reclutamento
        • The Cancer Institute Hospital of JFCR
  • Italia
    • Emilia-Romagna
      • Reggio Emilia, Emilia-Romagna, Italia, 42123
        • Non ancora reclutamento
        • Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale
    • Lazio
      • Rome, Lazio, Italia, 00168
        • Reclutamento
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
    • Lombardy
      • Milan, Lombardy, Italia, 20133
        • Reclutamento
        • Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
      • Milan, Lombardy, Italia, 20141
        • Non ancora reclutamento
        • Istituto Europeo di Oncologia s.r.l - Ginecologia Oncologica Medica
  • Spagna
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spagna, 08908
        • Reclutamento
        • Institut Catala D'oncologia | Hospitalet | Oncologia
    • Catalonia
      • Barcelona, Catalonia, Spagna, 08028
        • Non ancora reclutamento
        • Instituto Oncologico Dr. Rosell S.L. | Oncologia
      • Barcelona, Catalonia, Spagna, 08035
        • Reclutamento
        • Hospital Universitari Vall D Hebron | Oncologia Medica
    • Madrid
      • Madrid, Madrid, Spagna, 28027
        • Non ancora reclutamento
        • Clinica Universidad De Navarra | Madrid | Oncologia
      • Madrid, Madrid, Spagna, 28040
        • Attivo, non reclutante
        • Hospital Universitario Fundacion Jimenez Diaz | Oncologia Medica
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35233
        • Non ancora reclutamento
        • UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital
    • California
      • Duarte, California, Stati Uniti, 91010
        • Reclutamento
        • City of Hope - Duarte Cancer Center
    • Florida
      • Fort Myers, Florida, Stati Uniti, 33908
        • Reclutamento
        • Florida Cancer Specialists & Research Institute - Fort Myers Cancer Center - Gladiolus
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02215
        • Reclutamento
        • Dana-Farber Cancer Institute - Oncology Department
    • Michigan
      • Detroit, Michigan, Stati Uniti, 48202
        • Ritirato
        • Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
      • Farmington Hills, Michigan, Stati Uniti, 48334
        • Ritirato
        • Profound Research -OMG - TriAtria Cancer Center
    • Ohio
      • Cleveland, Ohio, Stati Uniti, 44195
        • Reclutamento
        • Cleveland Clinic - Oncology Department
    • Tennessee
      • Nashville, Tennessee, Stati Uniti, 37203
        • Reclutamento
        • SCRI Oncology Partners
    • Texas
      • Houston, Texas, Stati Uniti, 77030
        • Reclutamento
        • The University of Texas MD Anderson Cancer Center - Texas Medical Center
    • Washington
      • Seattle, Washington, Stati Uniti, 98195
        • Ritirato
        • Gynecology Oncology clinic at UW Medical Center - Montlake
    • Wisconsin
      • Madison, Wisconsin, Stati Uniti, 53792
        • Non ancora reclutamento
        • UW Health Carbone Cancer Center
  • Svizzera
      • Bern, Svizzera, 3010
        • Non ancora reclutamento
        • Inselspital Bern - Universitätsklinik für Medizinische Onkologie
      • Geneva, Svizzera, 1205
        • Non ancora reclutamento
        • Hopitaux Universitaires de Geneve - Oncology Department
      • Zurich, Svizzera, 8091
        • Reclutamento
        • UniversitätsSpital Zürich (USZ) - Klinik für Medizinische Onkologie und Hämatologie

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Documented histologically or cytologically confirmed locally advanced, unresectable or metastatic solid tumor cancer (colorectal carcinoma; biliary tract cancer; bladder and urothelial tract cancer; cervical cancer; endometrial cancer; breast cancer; other solid tumor cancer, excluding NSCLC)
  • Participant must be ≥18 years of age or over the legal age of consent
  • Patients who have received prior standard therapy appropriate for their tumor type and stage of disease, or who have no satisfactory alternative treatments
  • Documented activating HER2 mutation
  • At least one measurable lesion that would qualify as a target lesion by RECIST 1.1 criteria

Exclusion Criteria:

  • Primary diagnosis of non-small cell lung cancer (NSCLC)
  • Prior treatment with a HER2 tyrosine kinase inhibitor (TKI)
  • Active brain metastases
  • Uncontrolled, severe, intercurrent illness

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: BAY2927088

Adult participants with metastatic or unresectable solid tumors with HER-2 activating mutations including: colorectal, biliary tract, bladder, cervical, endometrial, breast, and other solid tumor types. Participants will receive BAY2927088 20 mg BID until disease progression per RECICST 1.1, unacceptable toxicity, or until any other withdrawal criteria.

RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BID: twice a day
Droga: BAY2927088

tablet, oral

Altri nomi:
  • Sevabertinib

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR
Lasso di tempo: From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first

ORR is defined as the proportion of participants with a best overall response of confirmed complete response (CR) or partial response (PR) per RECIST 1.1 by BICR. CR is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have decreased in size to have a short axis of <10 mm. PR is defined as a ≥30% decrease in the sum of diameters of target lesions taking as reference the baseline sum of diameters.

RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Duration of response (DOR) per RECIST 1.1 as assessed by BICR
Lasso di tempo: From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first

DOR is defined as the time from date of first documented complete or partial response (if confirmed) until the earliest date of progressive disease (PD) per RECIST 1.1 as assessed by BICR, or death from any cause, whichever occurs first. PD is defined as a ≥20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD.

RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
Time to response (TTR) per RECIST 1.1 as assessed by BICR
Lasso di tempo: From first participant enrolled until end of treatment or end of imaging active follow-up (up to approximately 3 years)

TTR is defined as the time from the start of study treatment until the date of first documented complete or partial response (if confirmed) per RECIST 1.1 as assessed by BICR.

RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1; BICR = blinded independent central review (BICR)
From first participant enrolled until end of treatment or end of imaging active follow-up (up to approximately 3 years)
ORR per RECIST 1.1 as assessed by the investigator
Lasso di tempo: From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first

ORR is defined as the proportion of participants with a best overall response of confirmed CR or confirmed PR per RECIST 1.1 by investigator.

RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
Disease control rate (DCR) per RECIST 1.1 as assessed by BICR
Lasso di tempo: From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first

DCR is defined as the proportion of participants with a best overall response of confirmed complete response (CR) or partial response (PR) or stable disease (SD), by the BICR per RECIST 1.1. SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
DCR ≥12 weeks per RECIST 1.1 as assessed by BICR
Lasso di tempo: From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first

Defined as the proportion of participants with a best overall response of confirmed CR or PR or SD (for at least 12 weeks following the first study intervention), by the BICR per RECIST 1.1.
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
Progression-free survival (PFS) per RECIST 1.1 as assessed by BICR
Lasso di tempo: From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first

Defined as the time from date of start of treatment until the earliest date of PD per RECIST 1.1 as assessed by the BICR, or death from any cause, whichever occurs first.
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
Disease control rate (DCR) per RECIST 1.1 as assessed by the investigator
Lasso di tempo: From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first

Defined as the proportion of participants with a best overall response of confirmed CR or PR or SD, by the investigator per RECIST 1.1.
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
DCR ≥12 weeks per RECIST 1.1 as assessed by the investigator
Lasso di tempo: From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first

Defined as the proportion of participants with a best overall response of confirmed CR or PR or SD (for at least 12 weeks following the first study intervention), by the investigator per RECIST 1.1.
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
Progression-free survival (PFS) per RECIST 1.1 as assessed by the investigator
Lasso di tempo: From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first

Defined as the time from date of start of treatment until the earliest date of PD per RECIST 1.1 as assessed by the investigator, or death from any cause, whichever occurs first
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
DOR per RECIST 1.1 as assessed by the investigator
Lasso di tempo: From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first

DOR is defined as the time from date of first documented complete or partial response (if confirmed) until the earliest date of PD per RECIST 1.1 as assessed by the investigator, or death from any cause, whichever occurs first.

RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1
From start of study intervention until the first documented progression, or death from any cause, or end of study (up to approximately 3 years), whichever comes first
TTR per RECIST 1.1 as assessed by the investigator
Lasso di tempo: From first participant enrolled until end of treatment or end of imaging active follow-up (up to approximately 3 years)

TTR is defined as the time from the start of study treatment until the date of first documented complete or partial response (if confirmed) per RECIST 1.1 as assessed by the investigator.

RECIST 1.1 = Response Evaluation Criteria in Solid Tumors, version 1.1
From first participant enrolled until end of treatment or end of imaging active follow-up (up to approximately 3 years)
Overall survival (OS)
Lasso di tempo: From start of study intervention until death from any cause, or end of study (up to approximately 3 years), whichever comes first

Defined as the time from the start of study treatment to the date of death from any cause.
From start of study intervention until death from any cause, or end of study (up to approximately 3 years), whichever comes first
Number of participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs) per CTCAE v 5.0, categorized by severity, including number of participants who discontinue study treatment due to an AE
Lasso di tempo: From first participant enrolled until up to 30 days after the last administration of study treatment

From first administration of study intervention up to 30 days after the last dose of study intervention.
From first participant enrolled until up to 30 days after the last administration of study treatment
Time to deterioration in EORTC QLQ-C30 physical functioning domain score
Lasso di tempo: Baseline and up until end of treatment or end of imaging active follow-up (up to approximately 3 years)

The EORTC QLQ-C30 is a multi-dimensional validated cancer-specific quality of life (QoL) questionnaire developed by the EORTC Study Group on QoL for use in international clinical trial settings. The EORTC QLQ-C30 will be used to evaluate the time to deterioration in the physical functioning domain score.

EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30
Baseline and up until end of treatment or end of imaging active follow-up (up to approximately 3 years)
Change from baseline in EORTC QLQ-C30 physical functioning domain score
Lasso di tempo: Baseline and up until end of treatment or end of imaging active follow-up (up to approximately 3 years)

The EORTC QLQ-C30 is a multi-dimensional validated cancer-specific quality of life (QoL) questionnaire developed by the EORTC Study Group on QoL for use in international clinical trial settings. The EORTC QLQ-C30 will be used to evaluate the change from baseline in the physical functioning domain score.

EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30
Baseline and up until end of treatment or end of imaging active follow-up (up to approximately 3 years)
Change from baseline in EORTC QLQ-C30 global health status/quality of life (QoL)
Lasso di tempo: Baseline and up until end of treatment or end of imaging active follow-up (up to approximately 3 years)

The EORTC QLQ-C30 is a multi-dimensional validated cancer-specific quality of life (QoL) questionnaire developed by the EORTC Study Group on QoL for use in international clinical trial settings. The EORTC QLQ-C30 will be used to evaluate the change from baseline in global health status/QoL.

EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30
Baseline and up until end of treatment or end of imaging active follow-up (up to approximately 3 years)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Bayer

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

13 febbraio 2025

Completamento primario (Stimato)

2 febbraio 2029

Completamento dello studio (Stimato)

26 ottobre 2029

Date di iscrizione allo studio

Primo inviato

18 dicembre 2024

Primo inviato che soddisfa i criteri di controllo qualità

30 dicembre 2024

Primo Inserito (Effettivo)

7 gennaio 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 novembre 2026

Ultimo verificato

2 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 22752
  • 2024-517419-62-00 (Identificatore di registro: CTIS (EU))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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