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Badanie mające na celu dowiedzenie się więcej o skuteczności leczenia tabletkami BAY2927088 i jego bezpieczeństwie u pacjentów z guzem litym z mutacjami receptora 2 ludzkiego naskórkowego czynnika wzrostu (HER2) (panSOHO)

2 listopada 2026 zaktualizowane przez: Bayer

Otwarte badanie koszykowe fazy 2 mające na celu ocenę skuteczności i bezpieczeństwa podawanego doustnie odwracalnego inhibitora kinazy tyrozynowej BAY 2927088 u uczestników z przerzutowymi lub nieresekcyjnymi guzami litymi z mutacjami aktywującymi 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Szacowany)

111

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Nielosowe
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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
Lek: BAY2927088

tablet, oral

Inne nazwy:
  • Sevabertinib

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Duration of response (DOR) per RECIST 1.1 as assessed by BICR
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Bayer

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

13 lutego 2025

Zakończenie podstawowe (Szacowany)

2 lutego 2029

Ukończenie studiów (Szacowany)

26 października 2029

Daty rejestracji na studia

Pierwszy przesłany

18 grudnia 2024

Pierwszy przesłany, który spełnia kryteria kontroli jakości

30 grudnia 2024

Pierwszy wysłany (Rzeczywisty)

7 stycznia 2025

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

4 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 listopada 2026

Ostatnia weryfikacja

2 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 22752
  • 2024-517419-62-00 (Identyfikator rejestru: CTIS (EU))

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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