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Bezpieczeństwo, tolerancja, farmakokinetyka i skuteczność akapatamabu u pacjentów z mCRPC

19 sierpnia 2026 zaktualizowane przez: Amgen

Badanie I fazy oceniające bezpieczeństwo, tolerancję, farmakokinetykę i skuteczność antygenu błonowego swoistego dla gruczołu krokowego, przedłużony okres półtrwania, dwuswoisty aktywator limfocytów T akapatamabu u pacjentów z opornym na kastrację rakiem gruczołu krokowego z przerzutami

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).

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

212

Faza

  • Faza 1

Kontakty i lokalizacje

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

Lokalizacje studiów

  • 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
  • Belgia
      • Brussels, Belgia, 1200
        • Universite Catholique de Louvain Cliniques Universitaires Saint Luc
      • Ghent, Belgia, 9000
        • Universitair Ziekenhuis Gent
  • Francja
      • Villejuif, Francja, 94805
        • Institut Gustave Roussy
  • Holandia
      • Rotterdam, Holandia, 3015 GD
        • Erasmus Medisch Centrum
  • Japonia
    • Chiba
      • Kashiwa-shi, Chiba, Japonia, 277-8577
        • National Cancer Center Hospital East
    • Kanagawa
      • Yokohama, Kanagawa, Japonia, 232-0024
        • Yokohama City University Medical Center
  • Kanada
    • British Columbia
      • Vancouver, British Columbia, Kanada, V5Z 4E6
        • BC Cancer Vancouver
  • Singapur
      • Singapore, Singapur, 119074
        • National University Hospital
      • Singapore, Singapur, 169610
        • National Cancer Centre Singapore
  • Stany Zjednoczone
    • California
      • Campbell, California, Stany Zjednoczone, 95008
        • El Camino Hospital
      • Duarte, California, Stany Zjednoczone, 91010
        • City of Hope National Medical Center
      • Long Beach, California, Stany Zjednoczone, 90813
        • City of Hope at Long Beach Elm
      • Los Angeles, California, Stany Zjednoczone, 90095
        • University of California Los Angeles
    • Georgia
      • Atlanta, Georgia, Stany Zjednoczone, 30322
        • Emory University
    • Indiana
      • Indianapolis, Indiana, Stany Zjednoczone, 46202
        • Indiana University
    • Iowa
      • Iowa City, Iowa, Stany Zjednoczone, 52242
        • University of Iowa Hospitals and Clinics
    • Louisiana
      • New Orleans, Louisiana, Stany Zjednoczone, 70112
        • Tulane Medical Center
    • Missouri
      • St Louis, Missouri, Stany Zjednoczone, 63110
        • Washington University
    • Nevada
      • Las Vegas, Nevada, Stany Zjednoczone, 89169
        • Comprehensive Cancer Centers of Nevada
    • New York
      • New York, New York, Stany Zjednoczone, 10065
        • Weill Cornell Medical College
      • New York, New York, Stany Zjednoczone, 10065
        • Memorial Sloan Kettering Cancer Center
    • Texas
      • Dallas, Texas, Stany Zjednoczone, 75390
        • University of Texas Southwestern Medical Center
  • Tajwan
      • Taoyuan, Tajwan, 33305
        • Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

Kryteria uczestnictwa

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

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Męski

Opis

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 studiów

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

Jak projektuje się badanie?

Szczegóły projektu

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

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Lek: acapatamab

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

Inne nazwy:
  • Terapia celowana PSMA
Eksperymentalny: Part 1 Dose-expansion: acapatamab treatment

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

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

Inne nazwy:
  • Terapia celowana PSMA
Eksperymentalny: Part 2: acapatamab + Pembrolizumab

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

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

Inne nazwy:
  • Terapia celowana PSMA
Lek: Pembrolizumab

Combined with acapatamab for investigational treatment of mCRPC

Inne nazwy:
  • Inhibitor PD-1
Eksperymentalny: Part 3: acapatamab + Etanercept Prophylaxis

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

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

Inne nazwy:
  • Terapia celowana PSMA
Lek: Etanercept

Prophylaxis for acapatamab-related cytokine release syndrome.

Inne nazwy:
  • Inhibitor TNF-alfa
Eksperymentalny: Part 4: acapatamab 24 Hour Monitoring

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

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

Inne nazwy:
  • Terapia celowana PSMA
Eksperymentalny: Part 5: acapatamab Outpatient Cohort

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

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

Inne nazwy:
  • Terapia celowana PSMA
Eksperymentalny: 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.
Lek: acapatamab

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

Inne nazwy:
  • Terapia celowana PSMA
Lek: Cytochrome P450 (CYP) Cocktail

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

Inne nazwy:
  • Koktajl fenotypowy Cooperstown 5+1 CYP

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants With a Dose Limiting Toxicity (DLT)- Parts 1 and 2
Ramy czasowe: 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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Objective Response (OR) Rate- Parts 1, 2, 3, 4, and 5
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Amgen

Śledczy

  • Dyrektor Studium: MD, Amgen

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

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

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

5 lutego 2019

Zakończenie podstawowe (Rzeczywisty)

29 czerwca 2023

Ukończenie studiów (Rzeczywisty)

29 czerwca 2023

Daty rejestracji na studia

Pierwszy przesłany

2 stycznia 2019

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 stycznia 2019

Pierwszy wysłany (Rzeczywisty)

3 stycznia 2019

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

10 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

19 sierpnia 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 20180101

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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

Ramy czasowe udostępniania 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.

Kryteria dostępu do udostępniania 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.

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • SOK ROŚLINNY
  • ICF
  • CSR

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Tak

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

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

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