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Innocuité, tolérabilité, pharmacocinétique et efficacité de l'acapatamab chez les sujets atteints de CPRCm

19 août 2026 mis à jour par: Amgen

Une étude de phase 1 évaluant l'innocuité, la tolérabilité, la pharmacocinétique et l'efficacité de l'Acapatamab de l'Acapatamab de l'Acapatamab de l'antigène membranaire spécifique de la prostate à demi-vie prolongée chez des sujets atteints d'un cancer de la prostate métastatique résistant à la castration

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).

Aperçu de l'étude

Statut

Résilié

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

212

Phase

  • La phase 1

Contacts et emplacements

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

Lieux d'étude

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

Critères de participation

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

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Homme

La description

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 d'étude

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

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation séquentielle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: acapatamab

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

Autres noms:
  • Thérapie ciblée PSMA
Expérimental: Part 1 Dose-expansion: acapatamab treatment

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

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

Autres noms:
  • Thérapie ciblée PSMA
Expérimental: Part 2: acapatamab + Pembrolizumab

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

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

Autres noms:
  • Thérapie ciblée PSMA
Médicament: Pembrolizumab

Combined with acapatamab for investigational treatment of mCRPC

Autres noms:
  • Inhibiteur PD-1
Expérimental: Part 3: acapatamab + Etanercept Prophylaxis

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

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

Autres noms:
  • Thérapie ciblée PSMA
Médicament: Etanercept

Prophylaxis for acapatamab-related cytokine release syndrome.

Autres noms:
  • Inhibiteur du TNF-alpha
Expérimental: Part 4: acapatamab 24 Hour Monitoring

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

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

Autres noms:
  • Thérapie ciblée PSMA
Expérimental: Part 5: acapatamab Outpatient Cohort

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

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

Autres noms:
  • Thérapie ciblée PSMA
Expérimental: 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.
Médicament: acapatamab

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

Autres noms:
  • Thérapie ciblée PSMA
Médicament: Cytochrome P450 (CYP) Cocktail

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

Autres noms:
  • Cocktail de phénotypage Cooperstown 5+1 CYP

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Number of Participants With a Dose Limiting Toxicity (DLT)- Parts 1 and 2
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Objective Response (OR) Rate- Parts 1, 2, 3, 4, and 5
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)

Collaborateurs et enquêteurs

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

Parrainer

Amgen

Les enquêteurs

  • Directeur d'études: MD, Amgen

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

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

Dates principales de l'étude

Début de l'étude (Réel)

5 février 2019

Achèvement primaire (Réel)

29 juin 2023

Achèvement de l'étude (Réel)

29 juin 2023

Dates d'inscription aux études

Première soumission

2 janvier 2019

Première soumission répondant aux critères de contrôle qualité

2 janvier 2019

Première publication (Réel)

3 janvier 2019

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

19 août 2026

Dernière vérification

1 août 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 20180101

Plan pour les données individuelles des participants (IPD)

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

OUI

Description du régime IPD

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

Délai de partage 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.

Critères d'accès au partage 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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • CIF
  • RSE

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

Étudie un produit pharmaceutique réglementé par la FDA américaine

Oui

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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

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