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Seguridad, tolerabilidad, farmacocinética y eficacia de acapatamab en sujetos con CPRCm

19 de agosto de 2026 actualizado por: Amgen

Un estudio de fase 1 que evalúa la seguridad, la tolerabilidad, la farmacocinética y la eficacia del antígeno prostático específico de membrana de vida media extendida biespecífico de células T Engager Acapatamab en sujetos con cáncer de próstata metastásico resistente a la castración

A phase 1 study evaluating the safety, tolerability, pharmacokinetics, and efficacy of prostate specific membrane antigen half-life extended bispecific T-cell engager acapatamab in subjects with metastatic castration-resistant prostate cancer, and to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

This is a phase I, first-in-human study to evaluate the safety and tolerability of acapatamab; a half-life extended (HLE) bispecific T-cell engager (BiTE®) construct, alone and in combination with pembrolizumab, etanercept prophylaxis and cytochrome P450 (CYP) phenotyping cocktail in subjects with metastatic castration-resistant prostate cancer.

Tipo de estudio

Intervencionista

Inscripción (Actual)

212

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Chris OBrien Lifehouse
      • Randwick, New South Wales, Australia, 2031
        • Scientia Clinical Research Ltd
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Peter MacCallum Cancer Centre
  • Austria
      • Linz, Austria, 4020
        • Ordensklinikum Linz Elisabethinen
      • Salzburg, Austria, 5020
        • Landeskrankenhaus Salzburg
      • Vienna, Austria, 1090
        • Universitaetsklinikum Allgemeines Krankenhaus Wien
      • Vienna, Austria, 1020
        • Krankenhaus der Barmherzigen Brueder Wien
  • Bélgica
      • Brussels, Bélgica, 1200
        • Universite Catholique de Louvain Cliniques Universitaires Saint Luc
      • Ghent, Bélgica, 9000
        • Universitair Ziekenhuis Gent
  • Canadá
    • British Columbia
      • Vancouver, British Columbia, Canadá, V5Z 4E6
        • BC Cancer Vancouver
  • Estados Unidos
    • California
      • Campbell, California, Estados Unidos, 95008
        • El Camino Hospital
      • Duarte, California, Estados Unidos, 91010
        • City of Hope National Medical Center
      • Long Beach, California, Estados Unidos, 90813
        • City of Hope at Long Beach Elm
      • Los Angeles, California, Estados Unidos, 90095
        • University of California Los Angeles
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Emory University
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Indiana University
    • Iowa
      • Iowa City, Iowa, Estados Unidos, 52242
        • University of Iowa Hospitals and Clinics
    • Louisiana
      • New Orleans, Louisiana, Estados Unidos, 70112
        • Tulane Medical Center
    • Missouri
      • St Louis, Missouri, Estados Unidos, 63110
        • Washington University
    • Nevada
      • Las Vegas, Nevada, Estados Unidos, 89169
        • Comprehensive Cancer Centers of Nevada
    • New York
      • New York, New York, Estados Unidos, 10065
        • Weill Cornell Medical College
      • New York, New York, Estados Unidos, 10065
        • Memorial Sloan Kettering Cancer Center
    • Texas
      • Dallas, Texas, Estados Unidos, 75390
        • University of Texas Southwestern Medical Center
  • Francia
      • Villejuif, Francia, 94805
        • Institut Gustave Roussy
  • Japón
    • Chiba
      • Kashiwa-shi, Chiba, Japón, 277-8577
        • National Cancer Center Hospital East
    • Kanagawa
      • Yokohama, Kanagawa, Japón, 232-0024
        • Yokohama City University Medical Center
  • Países Bajos
      • Rotterdam, Países Bajos, 3015 GD
        • Erasmus Medisch Centrum
  • Singapur
      • Singapore, Singapur, 119074
        • National University Hospital
      • Singapore, Singapur, 169610
        • National Cancer Centre Singapore
  • Taiwán
      • Taoyuan, Taiwán, 33305
        • Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Masculino

Descripción

All Parts

Inclusion Criteria:

  • Subject has provided informed consent prior to initiation of any study specific activities/procedures
  • Subjects with histologically or cytologically confirmed mCRPC who are refractory to a novel antiandrogen therapy (abiraterone, enzalutamide, and/or apalutamide) and have failed at least 1 (but not more than 2) taxane regimens (or who are deemed medically unsuitable to be treated with a taxane regimen or have actively refused treatment with a taxane regimen). Progression on novel antiandrogen therapy may have occurred in the non-metastatic CRPC setting
  • Subjects must have undergone bilateral orchiectomy or must be on continuous ADT with a gonadotropin releasing hormone (GnRH) agonist or antagonist
  • Total serum testosterone </= 50 ng/dL or 1.7 nmol/L
  • Evidence of progressive disease, defined as 1 or more PCWG3 criteria:
  • PSA level >/= 1 ng/mL that has increased on at least 2 successive occasions at least 1 week apart
  • nodal or visceral progression as defined by RECIST 1.1 with PCGW3 modifications
  • appearance of 2 or more new lesions in bone scan
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
  • Life expectancy >/= 6months

Exclusion Criteria:

  • Any anticancer therapy or immunotherapy within 4 weeks of start of first dose, not including luteinizing hormone-releasing hormone agonist (LHRH)/GnRH analogue (agonist/antagonist). Subjects on a stable bisophosphonate or denosumab regimen for >/= 30 days prior to randomization are eligible
  • Prior PSMA-targeted therapy (subjects on prior therapy may be eligible if discussed with Amgen medical monitor prior to enrollment)
  • Central nervous system (CNS) metastases, leptomeningeal disease, or spinal cord compression
  • Active autoimmune disease or any other diseases requiring immunosuppressive therapy while on study
  • Needing chronic systemic corticosteroid therapy (prednisone > 10 mg per day or equivalent) or any other immunosuppressive therapies (including anti-tumor necrosis factor alpha [TNF alpha] therapies) unless stopped 7 days prior to start of first dose
  • Myocardial infarction, unstable angina, cardiac arrhythmia requiring medication, and/or symptomatic congestive heart failure (New York Heart Association > class II) within 12 months of first dose of acapatamab

Part 2 only:

  • Subjects on a prior PD-1 or PD-L1 inhibitor who experienced a Grade 3 or higher immune-related adverse event prior to first day of dosing
  • History or evidence of interstitial lung disease or active, non-infectious pneumonitis

Part 3 only:

- Evidence of active tuberculosis on chest radiograph within 3 months prior to the first dose of investigational product

Part 6 only:

Subjects are excluded from this cohort if any of the following additional criteria apply:

  • Subjects taking strong OAT3 inhibitors (eg, probenecid) or adjust the dosing to 1 mg PO QD.
  • Subjects with latent or active tuberculosis at screening

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación Secuencial
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Part 1 Dose-exploration: acapatamab treatment

Part 1 dose-exploration: acapatamab is administered intravenously. The dose-exploration phase of the study will estimate the MTD of acapatamab. RP2D may be identified based on emerging safety, efficacy, and pharmacodynamic data prior to reaching an MTD.
Droga: acapatamab

Investigational immunotherapy for the treatment of metastatic castration-resistant prostate cancer

Otros nombres:
  • Terapia dirigida de PSMA
Experimental: Part 1 Dose-expansion: acapatamab treatment

Part 1 dose-expansion: acapatamab is administered intravenously at the MTD/RP2D.
Droga: acapatamab

Investigational immunotherapy for the treatment of metastatic castration-resistant prostate cancer

Otros nombres:
  • Terapia dirigida de PSMA
Experimental: Part 2: acapatamab + Pembrolizumab

Part 2: acapatamab is administered intravenously at the MTD/RP2D. Pembrolizumab will be administered intravenously.
Droga: acapatamab

Investigational immunotherapy for the treatment of metastatic castration-resistant prostate cancer

Otros nombres:
  • Terapia dirigida de PSMA
Droga: Pembrolizumab

Combined with acapatamab for investigational treatment of mCRPC

Otros nombres:
  • Inhibidor de PD-1
Experimental: Part 3: acapatamab + Etanercept Prophylaxis

Part 3: acapatamab is administered intravenously at RP2D/MTD levels. Etanercept will be administered subcutaneously in cycle 1 only.
Droga: acapatamab

Investigational immunotherapy for the treatment of metastatic castration-resistant prostate cancer

Otros nombres:
  • Terapia dirigida de PSMA
Droga: Etanercept

Prophylaxis for acapatamab-related cytokine release syndrome.

Otros nombres:
  • Inhibidor de TNF-alfa
Experimental: Part 4: acapatamab 24 Hour Monitoring

Part 4: acapatamab is administered intravenously at RP2D/MTD with 24-hour monitoring.
Droga: acapatamab

Investigational immunotherapy for the treatment of metastatic castration-resistant prostate cancer

Otros nombres:
  • Terapia dirigida de PSMA
Experimental: Part 5: acapatamab Outpatient Cohort

Part 5: acapatamab is administered intravenously at RP2D/MTD in an outpatient setting with 8-hour monitoring.
Droga: acapatamab

Investigational immunotherapy for the treatment of metastatic castration-resistant prostate cancer

Otros nombres:
  • Terapia dirigida de PSMA
Experimental: Part 6: acapatamab + Cytochrome P450 (CYP) Cocktail Drug Interaction

Part 6: acapatamab is administered intravenously at RP2D/MTD. A CYP phenotyping cocktail will be administered orally.
Droga: acapatamab

Investigational immunotherapy for the treatment of metastatic castration-resistant prostate cancer

Otros nombres:
  • Terapia dirigida de PSMA
Droga: Cytochrome P450 (CYP) Cocktail

Evaluate the effect of co-administration of multiple dosing of acapatamab on plasma

Otros nombres:
  • Cóctel de fenotipado CYP 5+1 de Cooperstown

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Participants With a Dose Limiting Toxicity (DLT)- Parts 1 and 2
Periodo de tiempo: Day 1 to 28 of Cycle 1 (length of cycle is 28 days)

DLTs are defined as any adverse event with an onset within first 28 days following first dose of AMG 160 monotherapy (Part 1) or in combination with pembrolizumab (Part 2) with any of the following criteria unless clearly attributable to causes other than AMG 160 treatment: • grade 5 toxicity (eg, death not due to disease progression)
Day 1 to 28 of Cycle 1 (length of cycle is 28 days)
Number of Participants With Treatment Emergent Adverse Events- Parts 1, 2, 3, 4, and 5
Periodo de tiempo: Up to 30 days after the last dose of study drug, or start of new anti-cancer therapy, whichever occurs first

A treatment-emergent adverse event is one that occurs on or after the first dose of study treatment and up to 30 days after the last dose. Adverse events were graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests were recorded as adverse events.
Up to 30 days after the last dose of study drug, or start of new anti-cancer therapy, whichever occurs first

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Objective Response (OR) Rate- Parts 1, 2, 3, 4, and 5
Periodo de tiempo: Up to 3 years

OR was defined as a partial response (PR) or complete response (CR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, confirmed by a repeat assessment at least 4 weeks later. Participants who did not experience a PR/CR or did not have any follow-up tumor assessments were regarded as non-responders.
Up to 3 years
Prostate-specific Antigen (PSA) Response- Parts 1, 2, 3, 4, and 5
Periodo de tiempo: Up to 3 years

A PSA response (PSA 30) is defined as a ≥ 30% reduction from the baseline PSA, (PSA 50) is defined as a ≥ 50% reduction from the baseline PSA, (PSA 70) is defined as a ≥ 70% reduction from the baseline PSA, and (PSA 90) is defined as a ≥ 90% reduction from the baseline PSA. PSA response must be confirmed by a second consecutive value ≥ 3 weeks later.
Up to 3 years
Duration of Response (DOR)-RECIST 1.1- Parts 1, 2, 3, 4, and 5
Periodo de tiempo: Up to 3 years

DOR is defined as the time from the date of an initial objective response per RECIST 1.1 to the earlier of progression or death. Participants who had not ended their response at the time of analysis had DOR censored at their last evaluable tumor assessment.
Up to 3 years
Duration of PSA Response- Parts 1, 2, 3, 4, and 5
Periodo de tiempo: Up to 3 years

PSA DOR is defined as the time from the date of an initial PSA response (PSA 50) to the earlier of PSA progression or death. Subjects who have not ended their response at the time of analysis will have PSA DOR censored on the date of their last PSA measurement. This endpoint only applies to subjects with a PSA response (PSA 50).
Up to 3 years
Percentage of Participants With 68Gallium (68Ga)-Prostate-specific Membrane Antigen (PSMA) Response Parts 1, 2, and 3
Periodo de tiempo: Up to 3 years

A Gallium PSMA-11 response is a ≥50% reduction from baseline in the maximum standardized uptake value (SUV) using 68Gallium (68Ga)-prostate-specific membrane antigen (PSMA)-11 positron emission tomography (PET)/computed tomography (CT).
Up to 3 years
Percentage of Participants With F-fluorodeoxyglucose (FDG) Response- Parts 1, 2, and 3
Periodo de tiempo: Up to 3 years

A FDG PET response is a ≥50% reduction from baseline in the maximum SUV using 18F-FDG PET/CT.
Up to 3 years
Time to Progression (Radiographic)- Parts 1, 2, 3, 4, and 5
Periodo de tiempo: Up to 3 years

Time to radiographic progression is defined as the time from study Day 1 until the first documentation of radiographic disease progression in the absence of subsequent anticancer therapy. Time to radiographic progression will be censored at the last evaluable post-baseline tumor assessment prior to subsequent anti-cancer therapy; otherwise, at study Day 1.
Up to 3 years
Time to Progression (PSA)- Parts 1, 2, 3, 4, and 5
Periodo de tiempo: Up to 3 years

Time to PSA progression is defined as the interval from study Day 1 to PSA progression; otherwise, time to PSA progression is censored on the date of the last PSA measurement. If a participant has no baseline or no post-baseline PSA measurement, time to PSA progression will be censored at study Day 1.
Up to 3 years
Progression Free Survival (Radiographic)- Parts 1, 2, 3, 4, and 5
Periodo de tiempo: Up to 3 years

Radiographic progression free survival (rPFS) is defined as the interval from study day 1 to the earlier of a radiographic progression or death from any cause; otherwise, rPFS is censored at the last evaluable tumor assessment date. If a subject has no post-baseline radiographic tumor assessment and a vital status of alive or unknown, rPFS will be censored at study day 1.
Up to 3 years
Progression Free Survival (PSA)- Parts 1, 2, 3, 4, and 5
Periodo de tiempo: Up to 3 years

PSA PFS is defined as the interval from study day 1 to the earlier of a PSA progression or death from any cause; otherwise, PSA PFS is censored on the date of the last PSA measurement. If a subject has no baseline or no post-baseline PSA measurement and a vital status of alive or unknown, PSA PFS will be censored at study day 1.
Up to 3 years
Overall Survival- Parts 1, 2, 3, 4, and 5
Periodo de tiempo: Up to 3 years

Overall survival (OS) is defined as the time from the date of study Day 1 until death due to any cause.
Up to 3 years
Percentage of Participants With Circulating Tumor Cell Response (CTC0)- Parts 1, 2, 3, 4, and 5
Periodo de tiempo: Up to 3 years

CTC0 is defined as reduction of CTCs > 0 to 0 at any post-baseline measurement. CTC0 response is applicable only for participants with baseline CTC > 0.
Up to 3 years
Percentage of Participants With CTC Conversion- Parts 1, 2, 3, 4, and 5
Periodo de tiempo: Up to 3 years

CTC conversion is defined as ≥ 5 CTCs/7.5 mL blood to ≤ 4 CTCs/7.5 mL blood at any post-baseline measurement. CTC conversion is applicable only for subjects with baseline CTC ≥ 5..
Up to 3 years
Time to Symptomatic Skeletal Events (SSE)- Parts 1, 2, 3, 4, and 5
Periodo de tiempo: Up to 3 years

Time to SSE is defined as time from study day 1 to the first SSE. Otherwise, SSE is censored at the last dose date of AMG 160 or pembrolizumab or end of safety follow up date, whichever is later.
Up to 3 years
Maximum Observed Concentration (Cmax) of AMG 160 - Parts 1, 2, and 3
Periodo de tiempo: Cycle 1 Days 1, 8, 15, and 22; Cycle 2 Days 1 and 15 (sampling pre-dose up to 168 hours post-dose)

Serum concentrations of AMG 160 were determined using a validated assay. Noncompartmental analysis was performed for the estimation of pharmacokinetic (PK) parameters. Concentrations below the lower limit of quantification (LLOQ) (0.0500 ng/mL) were set to zero before data analysis.

PK parameters, including Cmax, Tmax, Cmin, AUClast, AUCtau, t1/2,z, were not estimated for Parts 4 and 5 because the PK sampling schedule in these parts was sparse and not designed to support parameter estimation.
Cycle 1 Days 1, 8, 15, and 22; Cycle 2 Days 1 and 15 (sampling pre-dose up to 168 hours post-dose)
Time to Cmax (Tmax) of AMG 160- Parts 1, 2, and 3
Periodo de tiempo: Cycle 1 Days 1, 8, 15, and 22; Cycle 2 Days 1 and 15 (sampling pre-dose up to 696 hours)

Serum concentrations of AMG 160 were determined using a validated assay. Noncompartmental analysis was performed for the estimation of PK parameters. Concentrations below the LLOQ (0.0500 ng/mL) were set to zero before data analysis.

Actual time post dose was used for calculations.

PK parameters, including Cmax, Tmax, Cmin, AUClast, AUCtau, t1/2,z, were not estimated for Parts 4 and 5 because the PK sampling schedule in these parts was sparse and not designed to support parameter estimation.
Cycle 1 Days 1, 8, 15, and 22; Cycle 2 Days 1 and 15 (sampling pre-dose up to 696 hours)
Minimum Serum Concentration (Cmin) of AMG 160- Parts 1, 2, and 3
Periodo de tiempo: Cycle 1 Days 1, 8, 15, and 22; Cycle 2 Days 1 and 15 (sampling pre-dose up to 168 hours post-dose))

Serum concentrations of AMG 160 were determined using a validated assay. Noncompartmental analysis was performed for the estimation of PK parameters. Concentrations below the LLOQ (0.0500 ng/mL) were set to zero before data analysis.

PK parameters, including Cmax, Tmax, Cmin, AUClast, AUCtau, t1/2,z, were not estimated for Parts 4 and 5 because the PK sampling schedule in these parts was sparse and not designed to support parameter estimation.
Cycle 1 Days 1, 8, 15, and 22; Cycle 2 Days 1 and 15 (sampling pre-dose up to 168 hours post-dose))
Area Under the Concentration-time Curve (AUC) From Time 0 to Last Quantifiable Concentration (AUClast) of AMG 160- Parts 1, 2, and 3
Periodo de tiempo: Cycle 1 Days 1, 8, 15, and 22; Cycle 2 Days 1 and 15 (sampling pre-dose up to 168 hours post-dose))

Serum concentrations of AMG 160 were determined using a validated assay. Noncompartmental analysis was performed for the estimation of PK parameters. Concentrations below the LLOQ (0.0500 ng/mL) were set to zero before data analysis.

PK parameters, including Cmax, Tmax, Cmin, AUClast, AUCtau, t1/2,z, were not estimated for Parts 4 and 5 because the PK sampling schedule in these parts was sparse and not designed to support parameter estimation.
Cycle 1 Days 1, 8, 15, and 22; Cycle 2 Days 1 and 15 (sampling pre-dose up to 168 hours post-dose))
AUC Over the Dosing Interval (AUCtau)- Parts 1, 2, and 3
Periodo de tiempo: Cycle 1 Days 1, 8, 15, and 22; Cycle 2 Days 1 and 15 (sampling pre-dose up to 168 hours post-dose)

Serum concentrations of AMG 160 were determined using a validated assay. Noncompartmental analysis was performed for the estimation of PK parameters. Concentrations below the LLOQ (0.0500 ng/mL) were set to zero before data analysis.

PK parameters, including Cmax, Tmax, Cmin, AUClast, AUCtau, t1/2,z, were not estimated for Parts 4 and 5 because the PK sampling schedule in these parts was sparse and not designed to support parameter estimation.
Cycle 1 Days 1, 8, 15, and 22; Cycle 2 Days 1 and 15 (sampling pre-dose up to 168 hours post-dose)
Terminal Half-life (t1/2,z) of AMG 160- Parts 1, 2, and 3
Periodo de tiempo: Cycle 1 Days 1, 8, 15, and 22; Cycle 2 Days 1 and 15 (sampling pre-dose up to 168 hours post-dose)

Serum concentrations of AMG 160 were determined using a validated assay. Noncompartmental analysis was performed for the estimation of PK parameters. Concentrations below the LLOQ (0.0500 ng/mL) were set to zero before data analysis.

PK parameters, including Cmax, Tmax, Cmin, AUClast, AUCtau, t1/2,z, were not estimated for Parts 4 and 5 because the PK sampling schedule in these parts was sparse and not designed to support parameter estimation.
Cycle 1 Days 1, 8, 15, and 22; Cycle 2 Days 1 and 15 (sampling pre-dose up to 168 hours post-dose)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Amgen

Investigadores

  • Director de estudio: MD, Amgen

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

5 de febrero de 2019

Finalización primaria (Actual)

29 de junio de 2023

Finalización del estudio (Actual)

29 de junio de 2023

Fechas de registro del estudio

Enviado por primera vez

2 de enero de 2019

Primero enviado que cumplió con los criterios de control de calidad

2 de enero de 2019

Publicado por primera vez (Actual)

3 de enero de 2019

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

19 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 20180101

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Marco de tiempo para compartir IPD

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe, or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

Criterios de acceso compartido de IPD

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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. .

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