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Une étude pour en savoir plus sur l'efficacité du traitement avec les comprimés BAY2927088 et sa sécurité chez les participants qui ont une tumeur solide avec des mutations du récepteur 2 du facteur de croissance épidermique humain (HER2) (panSOHO)

2 novembre 2026 mis à jour par: Bayer

Une étude ouverte de phase 2 en panier pour évaluer l'efficacité et l'innocuité de l'inhibiteur réversible de la tyrosine kinase BAY 2927088 administré par voie orale chez des participants atteints de tumeurs solides métastatiques ou non résécables avec des mutations activant 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.

Aperçu de l'étude

Statut

Recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

111

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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
Médicament: BAY2927088

tablet, oral

Autres noms:
  • Sévabertinib

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Duration of response (DOR) per RECIST 1.1 as assessed by BICR
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Bayer

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

13 février 2025

Achèvement primaire (Estimé)

2 février 2029

Achèvement de l'étude (Estimé)

26 octobre 2029

Dates d'inscription aux études

Première soumission

18 décembre 2024

Première soumission répondant aux critères de contrôle qualité

30 décembre 2024

Première publication (Réel)

7 janvier 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

2 novembre 2026

Dernière vérification

2 novembre 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 22752
  • 2024-517419-62-00 (Identificateur de registre: CTIS (EU))

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime 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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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