Un estudio para obtener más información sobre qué tan bien funciona el tratamiento con tabletas BAY2927088 y qué tan seguro es en participantes que tienen un tumor sólido con mutaciones del receptor 2 del factor de crecimiento epidérmico humano (HER2) (panSOHO)
Un estudio de cesta de etiqueta abierta de fase 2 para evaluar la eficacia y seguridad del inhibidor de tirosina quinasa reversible BAY 2927088 administrado por vía oral en participantes con tumores sólidos metastásicos o irresecables con mutaciones activadoras de 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 2
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Bayer Clinical Trials Contact
- Número de teléfono: 0018888422937
- Correo electrónico: clinical-trials-contact@bayer.com
Ubicaciones de estudio
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New South Wales
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Blacktown, New South Wales, Australia, 2148
- Reclutamiento
- NSW Health - Blacktown Hospital
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Sydney, New South Wales, Australia, 2109
- Reclutamiento
- Macquarie University Hospital - Oncology Department
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Queensland
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Southport, Queensland, Australia, 4215
- Aún no reclutando
- ICON Cancer Centre - Southport
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Nova Scotia
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Halifax, Nova Scotia, Canadá, B3H 2Y9
- Retirado
- Queen Elizabeth II Health Sciences Centre | Oncology
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Ontario
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Toronto, Ontario, Canadá, M5G 2C4
- Reclutamiento
- Princess Margaret Cancer Centre | Medical Oncology and Hematology
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Quebec
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Montreal, Quebec, Canadá, H4A 3J1
- Retirado
- Research Institute of the McGill University Health Centre | Women Health's Research Unit
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Seoul, Corea del Sur, 05505
- Reclutamiento
- Asan Medical Center | Oncology
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Seoul, Corea del Sur, 03722
- Reclutamiento
- Severance Hospital | Oncology
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Seoul, Corea del Sur, 06351
- Reclutamiento
- Samsung Medical Center | Oncology
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Seoul
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Jongno -Gu, Seoul, Corea del Sur, 03080
- Activo, no reclutando
- Seoul National University Hospital | Oncology
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Capital Region / Region Hovedstaden
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Copenhagen, Capital Region / Region Hovedstaden, Dinamarca, 2100
- Reclutamiento
- Rigshospitalet Copenhagen University Hospital | Oncology Department
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Central Denmark Region / Region Midtjylland
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Aarhus N, Central Denmark Region / Region Midtjylland, Dinamarca, 8200
- Retirado
- Aarhus University Hospital | Oncology Department - Clinical Research Unit
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Region of Southern Denmark / Region Syddanmark
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Odense, Region of Southern Denmark / Region Syddanmark, Dinamarca, 5000
- Reclutamiento
- Odense University Hospital | Svendborg Sygehus - Oncology Department
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Barcelona
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L'Hospitalet de Llobregat, Barcelona, España, 08908
- Reclutamiento
- Institut Catala D'oncologia | Hospitalet | Oncologia
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Catalonia
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Barcelona, Catalonia, España, 08028
- Aún no reclutando
- Instituto Oncologico Dr. Rosell S.L. | Oncologia
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Barcelona, Catalonia, España, 08035
- Reclutamiento
- Hospital Universitari Vall D Hebron | Oncologia Medica
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Madrid
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Madrid, Madrid, España, 28027
- Aún no reclutando
- Clinica Universidad De Navarra | Madrid | Oncologia
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Madrid, Madrid, España, 28040
- Activo, no reclutando
- Hospital Universitario Fundacion Jimenez Diaz | Oncologia Medica
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Alabama
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Birmingham, Alabama, Estados Unidos, 35233
- Aún no reclutando
- UAB O'Neal Comprehensive Cancer Center - The Kirklin Clinic of UAB Hospital
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California
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Duarte, California, Estados Unidos, 91010
- Reclutamiento
- City of Hope - Duarte Cancer Center
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Florida
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Fort Myers, Florida, Estados Unidos, 33908
- Reclutamiento
- Florida Cancer Specialists & Research Institute - Fort Myers Cancer Center - Gladiolus
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02215
- Reclutamiento
- Dana-Farber Cancer Institute - Oncology Department
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Michigan
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Detroit, Michigan, Estados Unidos, 48202
- Retirado
- Brigette Harris Cancer Pavilion at Henry Ford Cancer Center - Detroit
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Farmington Hills, Michigan, Estados Unidos, 48334
- Retirado
- Profound Research -OMG - TriAtria Cancer Center
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- Reclutamiento
- Cleveland Clinic - Oncology Department
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Tennessee
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Nashville, Tennessee, Estados Unidos, 37203
- Reclutamiento
- SCRI Oncology Partners
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Texas
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Houston, Texas, Estados Unidos, 77030
- Reclutamiento
- The University of Texas MD Anderson Cancer Center - Texas Medical Center
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Washington
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Seattle, Washington, Estados Unidos, 98195
- Retirado
- Gynecology Oncology clinic at UW Medical Center - Montlake
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792
- Aún no reclutando
- UW Health Carbone Cancer Center
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Auvergne-Rhône-Alpes
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Pierre-Bénite, Auvergne-Rhône-Alpes, Francia, 69310
- Reclutamiento
- Centre Hospitalier Lyon Sud - Service oncologie medicale
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Brittany Region
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Brest, Brittany Region, Francia, 29200
- Reclutamiento
- CHU Brest - Hopital La Cavale Blanche - service oncologie medicale
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Hauts-de-France
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Lille, Hauts-de-France, Francia, 59000
- Aún no reclutando
- Centre Oscar Lambret - Service Oncologie
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New Aquitaine
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Bordeaux, New Aquitaine, Francia, 33000
- Reclutamiento
- Institut Bergonie - Unicancer Nouvelle Aquitaine - Service Oncologie medicale
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Occitanie
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Montpellier, Occitanie, Francia, 34298
- Aún no reclutando
- ICM - Institut du Cancer de Montpellier - Val d'Aurelle - CIPP
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Île-de-France Region
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Villejuif, Île-de-France Region, Francia, 94805
- Reclutamiento
- Institut Gustave Roussy - Departement d'Innovation Therapeutique et d'Essais Precoces (DITEP)
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Emilia-Romagna
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Reggio Emilia, Emilia-Romagna, Italia, 42123
- Aún no reclutando
- Azienda USL IRCCS di Reggio Emilia_Arcispedale Santa Maria Nuova - S.C. Oncologia Provinciale
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Lazio
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Rome, Lazio, Italia, 00168
- Reclutamiento
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica
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Lombardy
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Milan, Lombardy, Italia, 20133
- Reclutamiento
- Fondazione IRCCS Istituto Nazionale dei Tumori - S. C. Oncologia Medica 1
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Milan, Lombardy, Italia, 20141
- Aún no reclutando
- Istituto Europeo di Oncologia s.r.l - Ginecologia Oncologica Medica
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Aichi-ken
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Nagoya, Aichi-ken, Japón, 464-8681
- Reclutamiento
- Aichi Cancer Center Hospital
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Chiba
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Kashiwa, Chiba, Japón, 277-8577
- Reclutamiento
- National Cancer Center Hospital East (NCCHE) - Kashiwa Campus
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Hokkaido
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Sapporo, Hokkaido, Japón, 060-8648
- Reclutamiento
- Hokkaido University Hospital
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Osaka
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Sakai, Osaka, Japón, 590-0197
- Reclutamiento
- Kindai University Hospital
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Tokyo
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Chuo-ku, Tokyo, Japón, 104-0045
- Reclutamiento
- National Cancer Center Hospital
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Koto-ku, Tokyo, Japón, 135-8550
- Reclutamiento
- The Cancer Institute Hospital of JFCR
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100142
- Reclutamiento
- Beijing Cancer Hospital - Oncology Department
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Beijing, Beijing Municipality, Porcelana, 100034
- Reclutamiento
- Peking University First Hospital - Oncology Department
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Hunan
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Changsha, Hunan, Porcelana, 410013
- Aún no reclutando
- Hunan Cancer Hospital - Oncology Department
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Shanghai Municipality
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Shanghai, Shanghai Municipality, Porcelana, 200000
- Reclutamiento
- Fudan University Shanghai Cancer Center - Oncology Department
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Shanghai, Shanghai Municipality, Porcelana, 200032
- Reclutamiento
- Zhongshan Hospital, Fudan University
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Zhejiang
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Hangzhou, Zhejiang, Porcelana, 310016
- Aún no reclutando
- Sir Run Run Shaw Hospital, Zhejiang Univ. School of Medicine - Oncology Department
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Bern, Suiza, 3010
- Aún no reclutando
- Inselspital Bern - Universitätsklinik für Medizinische Onkologie
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Geneva, Suiza, 1205
- Aún no reclutando
- Hopitaux Universitaires de Geneve - Oncology Department
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Zurich, Suiza, 8091
- Reclutamiento
- UniversitätsSpital Zürich (USZ) - Klinik für Medizinische Onkologie und Hämatologie
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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 |
tablet, oral
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Objective Response Rate (ORR) per RECIST 1.1 as assessed by BICR
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Duration of response (DOR) per RECIST 1.1 as assessed by BICR
Periodo de tiempo: 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
|
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Time to response (TTR) per RECIST 1.1 as assessed by BICR
Periodo de tiempo: 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)
|
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ORR per RECIST 1.1 as assessed by the investigator
Periodo de tiempo: 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
|
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Disease control rate (DCR) per RECIST 1.1 as assessed by BICR
Periodo de tiempo: 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
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DCR ≥12 weeks per RECIST 1.1 as assessed by BICR
Periodo de tiempo: 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
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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
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Progression-free survival (PFS) per RECIST 1.1 as assessed by BICR
Periodo de tiempo: 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
|
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Disease control rate (DCR) per RECIST 1.1 as assessed by the investigator
Periodo de tiempo: 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
|
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DCR ≥12 weeks per RECIST 1.1 as assessed by the investigator
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- Cáncer colonrectal
- Cáncer de vejiga
- Cáncer gástrico
- Cáncer de mama
- Cáncer de ovarios
- Cancer de pancreas
- Sarcoma
- Cáncer de esófago
- CDN
- Cáncer de cuello uterino
- Cáncer endometrial
- Cáncer gastrointestinal
- ESENCIA
- Cáncer ampular
- Cáncer de vesícula biliar
- Cáncer urotelial
- Cáncer de vías biliares
- Cáncer gastrointestinal
- Tumor del estroma gastrointestinal
- BTC
- Cáncer de saliva
- Cáncer mutante HER2
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Enfermedades del sistema endocrino
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades urogenitales masculinas
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades intestinales
- Neoplasias por tipo histológico
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades del Estómago
- Neoplasias Intestinales
- Enfermedades Rectales
- Enfermedades uterinas
- Enfermedades Genitales Femeninas
- Neoplasias de glándulas endocrinas
- Neoplasias de Cabeza y Cuello
- Enfermedades pancreáticas
- Enfermedades del Tracto Biliar
- Enfermedades del Colon
- Enfermedades esofágicas
- Enfermedades Ováricas
- Enfermedades anexiales
- Neoplasias Genitales Femeninas
- Trastornos gonadales
- Enfermedades de la piel
- Enfermedades de los senos
- Neoplasias Urológicas
- Enfermedades del cuello uterino
- Neoplasias Uterinas
- Neoplasias De Tejidos Conectivos Y Blandos
- Neoplasias Del Tejido Conectivo
- Enfermedades de la vejiga urinaria
- Enfermedades de la vesícula biliar
- Enfermedades de la piel y del tejido conectivo
- Neoplasias de Estómago
- Neoplasias del Tracto Biliar
- Neoplasias colorrectales
- Neoplasias Esofágicas
- Neoplasias Ováricas
- Neoplasias de mama
- Neoplasias pancreáticas
- Neoplasias Gastrointestinales
- Neoplasias del cuello uterino
- Sarcoma
- Neoplasias de la vejiga urinaria
- Neoplasias Endometriales
- Neoplasias de vesícula biliar
- Tumores del estroma gastrointestinal
Otros números de identificación del estudio
- 22752
- 2024-517419-62-00 (Identificador de registro: CTIS (EU))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .