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Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer (PROSPECTOR)

11 maggio 2026 aggiornato da: AstraZeneca

A Phase Ib/II, Open-label, Multi-centre, Platform Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Multiple Anti-Cancer Agents in Metastatic Prostate Cancer

The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of multiple anti-cancer agents in participants with metastatic prostate cancer.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This is a multicentre, open-label and platform study to evaluate multiple anti-cancer agents in participants with metastatic prostate cancer. This platform study will comprise a series of substudies. Each substudy will follow a 2-part structure (unless otherwise stated in the individual substudy):

  • Part A: A dose escalation (DE) phase to identify dose limiting toxicities (DLTs), characterise safety, PK, pharmacodynamics, preliminary efficacy, and determine biologically and clinically suitable dose levels to proceed into the dose optimisation/expansion.
  • Part B: A dose optimisation/expansion phase to inform recommended Phase 3 dose (RP3D), explore efficacy with Prostate-specific antigen (PSA) decrease ≥ 50% (PSA50) rate as primary endpoints, alongside continued safety monitoring.

Sub-study 1 focuses on a specific combination regimen and it will assess the safety, tolerability, PK, pharmacodynamics, and preliminary anti-tumour activity of AZD2265 (FPI-2265) in combination with AZD9574 compared with AZD2265 (FPI-2265) monotherapy and with standard-of-care (SoC) docetaxel chemotherapy in participants with metastatic castration resistant prostate cancer (mCRPC).

Tipo di studio

Interventistico

Iscrizione (Stimato)

152

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Australia
      • North Adelaide, Australia, 5000
        • Research Site
  • Corea del Sud
      • Seoul, Corea del Sud, 03080
        • Research Site
      • Seoul, Corea del Sud, 03722
        • Research Site
      • Seoul, Corea del Sud, 06351
        • Research Site
      • Seoul, Corea del Sud, 06591
        • Research Site
      • Seoul, Corea del Sud, 5505
        • Research Site
  • Germania
      • Essen, Germania, 45147
        • Research Site
      • Rostock, Germania, 18057
        • Research Site
      • Tübingen, Germania, 72076
        • Research Site
  • Italia
      • Bergamo, Italia, 24127
        • Research Site
      • Meldola, Italia, 47014
        • Research Site
      • Milan, Italia, 20141
        • Research Site
      • Milan, Italia, 20133
        • Research Site
      • Roma, Italia, 00168
        • Research Site
  • Regno Unito
      • Fulham, Regno Unito, SW3 6JJ
        • Research Site
      • Guildford, Regno Unito, CU2 7XX
        • Research Site
      • London, Regno Unito, WC1E 6DB
        • Research Site
      • Newcastle upon Tyne, Regno Unito, NE7 7DN
        • Research Site
      • Oxford, Regno Unito, OX3 7LE
        • Research Site
  • Spagna
      • Barcelona, Spagna, 08028
        • Research Site
      • L'Hospitalet de Llobregat, Spagna, 08908
        • Research Site
      • Madrid, Spagna, 28031
        • Research Site
      • Madrid, Spagna, 28041
        • Research Site
      • Pamplona, Spagna, 31008
        • Research Site
  • Stati Uniti
    • California
      • Encino, California, Stati Uniti, 91436
        • Research Site
      • South Pasadena, California, Stati Uniti, 91030
        • Research Site
    • Florida
      • Miami, Florida, Stati Uniti, 33165
        • Research Site
      • Tampa, Florida, Stati Uniti, 33612
        • Research Site
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti, 55455
        • Research Site
    • Nebraska
      • Omaha, Nebraska, Stati Uniti, 68130
        • Research Site
    • New York
      • New York, New York, Stati Uniti, 10065
        • Research Site
    • Oregon
      • Portland, Oregon, Stati Uniti, 97239
        • Research Site
    • Texas
      • Houston, Texas, Stati Uniti, 77030
        • Research Site

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  1. Participants with a diagnosis of histologically confirmed adenocarcinoma of the prostate (no small cell, neuroendocrine, sarcomatoid, spindle or signet cell).
  2. Minimum life expectancy of 3 months or more.
  3. Eastern Cooperative Oncology Group (ECOG) performance status of O or 1 at screening, with no deterioration.
  4. PCWG3 (Prostate Cancer Working Group 3) modified RECIST Version 1.1 evaluable disease.
  5. Must have received at least one novel androgen receptor pathway inhibitor (ARPI), such as enzalutamide or darolutamide or apalutamide or abiraterone acetate.
  6. Must have one or more unresectable metastatic lesions.
  7. Must have had prior orchiectomy and/or ongoing androgen deprivation therapy, and a castrate level of serum testosterone (<50ng/dL or <l.7nmol/L).
  8. Progressive metastatic castration-resistant prostate cancer (mCRPC) following the most recent treatment at time of study entry.
  9. Adequate organ and marrow function.
  10. Non sterilised participants who are sexually active with a partner of childbearing potential must use a condom (plus spermicide, if available), must refrain from fathering a child, freezing or donating sperm, and it is recommended for the partner to also use a highly effective contraceptive method.

Inclusion Criteria for Sub study 1:

  1. Must have received a single line of ARPI, such as enzalutamide, darolutamide, apalutamide or abiraterone acetate.
  2. PSMA positive mCRPC by computed tomography positron emission tomography, obtained with PSMA ligand defined as at least 1 PSMA positive metastatic lesion with tracer uptake greater than liver, and no PSMA negative lesions. All measurable or intraprostatic lesions must be PSMA positive.
  3. Capable of self-administering oral formulations.

Exclusion Criteria:

  1. Any evidence of non adenocarcinomatous forms of prostate cancer (including small cell, spindle cell, signet cell, neuroendocrine, sarcomatous).
  2. Known, unresolved urinary tract obstruction.
  3. Participants with a history of central nervous system metastases.
  4. Symptomatic malignant spinal cord compression or findings indicative of impending cord compression.
  5. Participants with a history of leptomeningeal carcinomatosis.
  6. Previous or concurrent cancer distinct from the cancer under investigation in primary site or histology .
  7. Concurrent serious medical conditions.
  8. Previous history of interstitial lung disease or non-infectious pneumonitis.
  9. Participants with a history or clinical/laboratory features suggestive of myelodysplastic syndrome or acute myeloid leukaemia.
  10. Persistent toxicities caused by previous therapy.
  11. Participants unable to swallow orally administered medications or with gastrointestinal disorders likely to interfere with absorption.
  12. Active infection, including tuberculosis, hepatitis C virus, and hepatitis B virus infection.
  13. Known hypersensitivity to study intervention or any of their excipients.

Exclusion Criteria for Sub study 1:

  1. History of uncontrolled seizures or requirement for >2 antiepileptic drugs.
  2. History of severe brain injury or stroke.
  3. Skeletal metastases demonstrating a superscan appearance on bone scan.
  4. Participants have received prior therapy with AZD9574 or more than 1 prior line of any other Poly-ADP-ribose polymerase inhibitor (PARPi)-based regimen (either as a treatment or as maintenance).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione sequenziale
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Sub study 1 Part A (SS1A): escalating dose levels of AZD9574 in combination with AZD2265 (FPI-2265)
Participants will receive escalating dose levels of AZD9574 once daily in combination with AZD2265 (FPI-2265) once every 6 weeks (Q6W).
Droga: AZD9574
AZD9574 verrà somministrato per via orale.
Droga: AZD2265 (FPI-2265)
AZD2265 (FPI-2265) will be administered as an intravenous (IV) injection.
Altri nomi:
  • FPI-2265
  • 225Ac-PSMA-I&T
Droga: AZD2287 (Imaging agent)
AZD2287 will be administered as an IV injection.
Sperimentale: Sub study 1 Part B (SS1B): selected dose of AZD9574 in combination with AZD2265 (FPI-2265)
Participants will receive AZD9574 chosen from the DE phase once daily in combination with AZD2265 (FPI-2265) Q6W.
Droga: AZD9574
AZD9574 verrà somministrato per via orale.
Droga: AZD2265 (FPI-2265)
AZD2265 (FPI-2265) will be administered as an intravenous (IV) injection.
Altri nomi:
  • FPI-2265
  • 225Ac-PSMA-I&T
Droga: AZD2287 (Imaging agent)
AZD2287 will be administered as an IV injection.
Sperimentale: SS1B: AZD2265 (FPI-2265) monotherapy
Participants will receive AZD2265 (FPI-2265) monotherapy Q6W.
Droga: AZD2265 (FPI-2265)
AZD2265 (FPI-2265) will be administered as an intravenous (IV) injection.
Altri nomi:
  • FPI-2265
  • 225Ac-PSMA-I&T
Droga: AZD2287 (Imaging agent)
AZD2287 will be administered as an IV injection.
Comparatore attivo: SS1B: Docetaxel
Participants will receive docetaxel as a standard of care (SoC) once every 3 weeks (Q3W).
Droga: AZD2287 (Imaging agent)
AZD2287 will be administered as an IV injection.
Droga: Docetaxel
Docetaxel will be administered as an IV infusion.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Part A: Number of participants with treatment-emergent adverse events (TEAEs)including serious adverse events (SAEs), treatment-related AEs (TRAEs) and adverse events of special interests (AESIs)
Lasso di tempo: Up to approximately 1 year after last dose
To assess the safety and tolerability of AZD9574 in combination with AZD2265 (FPI-2265).
Up to approximately 1 year after last dose
Part A: Number of participants with dose limiting toxicities (DLTs)
Lasso di tempo: From date of first dose up to approximately 2 cycles (up to 3 months)
To assess the safety and tolerability, and characterise the DLTs of AZD9574 in combination with AZD2265 (FPI-2265).
From date of first dose up to approximately 2 cycles (up to 3 months)
Part B: Number of participants with TEAEs
Lasso di tempo: Up to approximately 1 year after last dose
To further assess the safety and tolerability, and determine the recommended Phase 3 dose (RP3D) of AZD9574 in combination with AZD2265 (FPI-2265).
Up to approximately 1 year after last dose
Part B: Prostate Specific Antigen 50 (PSA50) response rate
Lasso di tempo: Up to 3 years 4 months
PSA50 response rate is defined as proportion of participants achieving a ≥ 50% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later, and occurring prior to confirmed PSA progression. PSA50 will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265).
Up to 3 years 4 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Part A and Part B: PSA50 response rate
Lasso di tempo: Up to 3 years 4 months
PSA50 response rate is defined as proportion of participants achieving a ≥ 50% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later, and occurring prior to confirmed PSA progression. PSA50 will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265) (Part A) and to demonstrate effectiveness of AZD2265 (FPI-2265) + AZD9574 relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B).
Up to 3 years 4 months
Part A and Part B: Prostate Specific Antigen 90 (PSA90) response rate
Lasso di tempo: Up to 3 years 4 months
PSA90 response rate is defined as proportion of participants achieving a ≥ 90% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later, and occurring prior to confirmed PSA progression. PSA90 will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + AZD9574 relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only).
Up to 3 years 4 months
Part A and Part B: Time to PSA50 (TTPSA50) response
Lasso di tempo: Up to 3 years 4 months
TTPSA50 response is defined as the time from date of randomisation/first dose of study intervention until the date of first documented PSA50 response (≥ 50% decrease in PSA from baseline), confirmed by a second consecutive PSA assessment at least 3 weeks later. TTPSA50 response will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265).
Up to 3 years 4 months
Part A and Part B: Time to PSA90 (TTPSA90) response
Lasso di tempo: Up to 3 years 4 months
TTPSA90 response is defined as the time from date of randomisation/first dose of study intervention until the date of first documented PSA90 response (≥ 90% decrease in PSA from baseline, respectively), confirmed by a second consecutive PSA assessment at least 3 weeks later. TTPSA90 response will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265).
Up to 3 years 4 months
Part A and Part B: Duration of PSA50 (DoPSA50) response
Lasso di tempo: Up to 3 years 4 months
DoPSA50 response is defined as the time from the date of first documented PSA50 response, that is subsequently confirmed by a second consecutive PSA assessment at least 3 weeks later, until the date of documented PSA progression. DoPSA50 response will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265).
Up to 3 years 4 months
Part A and Part B: Duration of PSA90 (DoPSA90) response
Lasso di tempo: Up to 3 years 4 months
DoPSA90 response is defined as the time from the date of first documented PSA90 response, that is subsequently confirmed by a second consecutive PSA assessment at least 3 weeks later, until the date of documented PSA progression. DoPSA90 response will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265).
Up to 3 years 4 months
Part A and Part B: Time to PSA progression
Lasso di tempo: Up to 3 years 4 months
TTPSA progression is defined as time from the date of randomisation/first dose of study intervention until the date of documented PSA progression or the last PSA result in the absence of progression. PSA progression is defined as an increase in PSA of ≥ 25% from the nadir and an absolute increase of at least 2 ng/mL above nadir beyond 12 weeks. PSA progression must be confirmed by a second value taken at least 3 weeks later. TTPSA progression will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265).
Up to 3 years 4 months
Part A and Part B: PSA over time
Lasso di tempo: Up to 3 years 4 months
PSA over time is defined as the longitudinal change in serum PSA from baseline across all on-study timepoints. PSA over time will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265).
Up to 3 years 4 months
Part A and Part B: Radiographic Progression-free survival (rPFS)
Lasso di tempo: From Day 1 to 3 years 4 months
rPFS is defined as the time from date of randomisation/first dose of study intervention until the date of objective disease progression according to response evaluation criteria in solid tumors (RECIST) 1.1 (for soft tissue disease) and prostate cancer working group 3 (PCWG3) criteria (for bone disease) as assessed by the investigator at the local site, or death (by any cause in the absence of progression), regardless of whether the participant withdraws from therapy or receives another anti-cancer therapy prior to progression. rPFS will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + AZD9574 relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only).
From Day 1 to 3 years 4 months
Part A and Part B: Overall Response Rate (ORR)
Lasso di tempo: From Day 1 to 3 years 4 months
The ORR is defined as the percentage of participants who have a confirmed complete response (CR) or confirmed partial response (PR), as the time from the date of first documented objective response (which is subsequently confirmed) until the date of radiographic disease progression or censored according to rules for rPFS. The ORR will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + AZD9574 relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only).
From Day 1 to 3 years 4 months
Part A and Part B: Best Overall Response (BOR)
Lasso di tempo: From Day 1 to 3 years 4 months
The BOR is defined as the best overall visit response the participant achieves as determined by the investigator at the local site. The BOR will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + AZD9574 relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only).
From Day 1 to 3 years 4 months
Part A and Part B: Duration of response (DoR)
Lasso di tempo: From Day 1 to 3 years 4 months
The DoR is defined based on RECIST 1.1 (for soft tissue disease) and PCWG3 criteria (for bone disease) as the time from the date of first documented objective response (which is subsequently confirmed) until date of radiographic disease progression or censored according to rules for rPFS. The DoR will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + AZD9574 relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only).
From Day 1 to 3 years 4 months
Part A and Part B: Time to Response (TTR)
Lasso di tempo: From Day 1 to 3 years 4 months
The TTR is defined as the time from the date of randomisation/first dose of study intervention until the date of first documented objective response, which is subsequently confirmed. The TTR will be assessed to check the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + AZD9574 relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only).
From Day 1 to 3 years 4 months
Part A and Part B: Percentage change in tumour size
Lasso di tempo: From Day 1 to 3 years 4 months
To assess the anti-tumour activity of AZD9574 in combination with AZD2265 (FPI-2265).
From Day 1 to 3 years 4 months
Part A and Part B: Plasma concentration of AZD9574
Lasso di tempo: From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
To determine the PK of AZD9574 in combination with AZD2265 (FPI-2265).
From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
Part A and Part B: Plasma concentration of AZD2265 (FPI-2265)
Lasso di tempo: From Cycle 1 Day 1 to Cycle 2 Day 1 (each cycle will be 42 days)
To determine the PK of AZD9574 in combination with AZD2265 (FPI-2265).
From Cycle 1 Day 1 to Cycle 2 Day 1 (each cycle will be 42 days)
Part A and Part B: Area under the concentration time curve (AUC)
Lasso di tempo: From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
To determine the PK (AUC) of AZD9574 in combination with AZD2265 (FPI-2265).
From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
Part A and Part B: Maximum observed drug concentration (Cmax)
Lasso di tempo: From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
To determine the PK (Cmax) of AZD9574 in combination with AZD2265 (FPI-2265).
From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
Part A and Part B: Time to reach Cmax (tmax)
Lasso di tempo: From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
To determine the PK (tmax) of AZD9574 in combination with AZD2265 (FPI-2265).
From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
Part A and Part B: Terminal elimination half-life (t½λz)
Lasso di tempo: From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
To determine the PK (t½λz) of AZD9574 in combination with AZD2265 (FPI-2265).
From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
Part A and Part B: Change from baseline in study-specific biomarker ABC in response to treatment
Lasso di tempo: Up to 3 years 4 months
To investigate pharmacodynamics of AZD9574 in combination with AZD2265 (FPI-2265) (for Part A and Part B) and of AZD2265 (FPI-2265) monotherapy (for Part B only).
Up to 3 years 4 months
Part A and Part B: Change from baseline in study-specific biomarker XYZ in response to treatment
Lasso di tempo: Up to 3 years 4 months
To investigate study-specific XYZ expression and relationship to response to the treatment.
Up to 3 years 4 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

AstraZeneca

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

14 maggio 2026

Completamento primario (Stimato)

5 settembre 2029

Completamento dello studio (Stimato)

5 settembre 2029

Date di iscrizione allo studio

Primo inviato

11 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

11 maggio 2026

Primo Inserito (Effettivo)

15 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • D7642C00001
  • 2025-524920-23 (Altro identificatore: EU CT number)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Periodo di condivisione IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Criteri di accesso alla condivisione IPD

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Malattie rare

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Sedi

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