Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

Tutkimus saadaksesi lisätietoja siitä, kuinka hyvin hoito BAY2927088-tableteilla toimii ja kuinka turvallista se on osallistujille, joilla on kiinteä kasvain, johon liittyy ihmisen epidermaalisen kasvutekijän reseptorin 2 (HER2) mutaatioita (panSOHO)

maanantai 2. marraskuuta 2026 päivittänyt: Bayer

Vaiheen 2 avoin koritutkimus suun kautta annetun reversiibelin tyrosiinikinaasi-inhibiittorin BAY 2927088 tehon ja turvallisuuden arvioimiseksi osallistujilla, joilla on etäpesäkkeitä tai ei-leikkauskelpoisia kiinteitä kasvaimia, joissa on HER2:ta aktivoivia mutaatioita

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.

Tutkimuksen yleiskatsaus

Tila

Rekrytointi

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

111

Vaihe

  • Vaihe 2

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Ei satunnaistettu
  • Inventiomalli: Yksittäinen ryhmätehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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
Lääke: BAY2927088

tablet, oral

Muut nimet:
  • Sevabertinibi

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Duration of response (DOR) per RECIST 1.1 as assessed by BICR
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Bayer

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Todellinen)

Torstai 13. helmikuuta 2025

Ensisijainen valmistuminen (Arvioitu)

Perjantai 2. helmikuuta 2029

Opintojen valmistuminen (Arvioitu)

Perjantai 26. lokakuuta 2029

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Keskiviikko 18. joulukuuta 2024

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Maanantai 30. joulukuuta 2024

Ensimmäinen Lähetetty (Todellinen)

Tiistai 7. tammikuuta 2025

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Keskiviikko 4. marraskuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Maanantai 2. marraskuuta 2026

Viimeksi vahvistettu

Maanantai 2. marraskuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 22752
  • 2024-517419-62-00 (Rekisterin tunniste: CTIS (EU))

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

EI

IPD-suunnitelman kuvaus

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.

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Joo

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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