Phase Ib/II Platform Study of Multiple Anti-Cancer Agents in Participants With Metastatic Prostate Cancer (PROSPECTOR)
25 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Descrição detalhada
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) actinium (225Ac) zadavotide guraxetan [hereafter referred to as AZD2265 (FPI-2265)] in combination with palacaparib (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 de estudo
Intervencional
Inscrição (Estimado)
152
Estágio
- Fase 2
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: AstraZeneca Clinical Study Information Center
- Número de telefone: 1-877-240-9479
- E-mail: information.center@astrazeneca.com
Locais de estudo
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Essen, Alemanha, 45147
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Jena, Alemanha, 07747
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Rostock, Alemanha, 18057
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Tübingen, Alemanha, 72076
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North Adelaide, Austrália, 5000
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Seoul, Coréia do Sul, 03080
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Seoul, Coréia do Sul, 03722
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Seoul, Coréia do Sul, 06591
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Seoul, Coréia do Sul, 06351
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Seoul, Coréia do Sul, 5505
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Barcelona, Espanha, 08028
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L'Hospitalet de Llobregat, Espanha, 08908
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Madrid, Espanha, 28041
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Madrid, Espanha, 28031
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Pamplona, Espanha, 31008
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California
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Duarte, California, Estados Unidos, 91010
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Encino, California, Estados Unidos, 91436
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South Pasadena, California, Estados Unidos, 91030
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Florida
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Miami, Florida, Estados Unidos, 33165
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Tampa, Florida, Estados Unidos, 33612
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Louisiana
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Metairie, Louisiana, Estados Unidos, 70006
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68130
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New York
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New York, New York, Estados Unidos, 10065
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Oregon
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Portland, Oregon, Estados Unidos, 97239
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Texas
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Houston, Texas, Estados Unidos, 77030
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Bergamo, Itália, 24127
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Meldola, Itália, 47014
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Milan, Itália, 20141
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Milan, Itália, 20133
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Roma, Itália, 00168
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Belfast, Reino Unido, BT9 7AB
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Fulham, Reino Unido, SW3 6JJ
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Guildford, Reino Unido, CU2 7XX
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London, Reino Unido, WC1E 6DB
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Newcastle upon Tyne, Reino Unido, NE7 7DN
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Oxford, Reino Unido, OX3 7LE
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
Inclusion Criteria:
- Participants with a diagnosis of histologically confirmed adenocarcinoma of the prostate (no small cell, neuroendocrine, sarcomatoid, spindle or signet cell).
- Minimum life expectancy of 3 months or more.
- Eastern Cooperative Oncology Group (ECOG) performance status of O or 1 at screening, with no deterioration.
- PCWG3 (Prostate Cancer Working Group 3) modified RECIST Version 1.1 evaluable disease.
- Must have received at least one novel androgen receptor pathway inhibitor (ARPI), such as enzalutamide or darolutamide or apalutamide or abiraterone acetate.
- Must have one or more unresectable metastatic lesions.
- Must have had prior orchiectomy and/or ongoing androgen deprivation therapy, and a castrate level of serum testosterone (<50ng/dL or <l.7nmol/L).
- Progressive metastatic castration-resistant prostate cancer (mCRPC) following the most recent treatment at time of study entry.
- Adequate organ and marrow function.
- 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:
- Must have received a single line of ARPI, such as enzalutamide, darolutamide, apalutamide or abiraterone acetate. Participants who were exposed to more than one ARPI due to toxicity or intolerance (not due to disease progression) are eligible.
- 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.
- Capable of self-administering oral formulations.
Exclusion Criteria:
- Any evidence of non adenocarcinomatous forms of prostate cancer (including small cell, spindle cell, signet cell, neuroendocrine, sarcomatous).
- Known, unresolved urinary tract obstruction.
- Participants with a history of central nervous system metastases.
- Symptomatic malignant spinal cord compression or findings indicative of impending cord compression.
- Participants with a history of leptomeningeal carcinomatosis.
- Previous or concurrent cancer distinct from the cancer under investigation in primary site or histology .
- Concurrent serious medical conditions.
- Previous history of interstitial lung disease or non-infectious pneumonitis.
- Participants with a history or clinical/laboratory features suggestive of myelodysplastic syndrome or acute myeloid leukaemia.
- Persistent toxicities caused by previous therapy.
- Participants unable to swallow orally administered medications or with gastrointestinal disorders likely to interfere with absorption.
- Active infection, including tuberculosis, hepatitis C virus, and hepatitis B virus infection.
- Known hypersensitivity to study intervention or any of their excipients.
Exclusion Criteria for Sub study 1:
- History of uncontrolled seizures or requirement for >2 antiepileptic drugs.
- History of severe brain injury or stroke.
- Skeletal metastases demonstrating a superscan appearance on bone scan.
- Participants have received prior therapy with palacaparib (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).
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição sequencial
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: SS1B: AZD2265 (FPI-2265) monotherapy
Participants will receive AZD2265 (FPI-2265) monotherapy Q6W.
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AZD2265 (FPI-2265) will be administered as an intravenous (IV) injection.
Outros nomes:
AZD2287 will be administered as an IV injection.
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Comparador Ativo: SS1B: Docetaxel
Participants will receive docetaxel as a standard of care (SoC) once every 3 weeks (Q3W).
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AZD2287 will be administered as an IV injection.
Docetaxel will be administered as an IV infusion.
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Experimental: Substudy 1 Part A(SS1A): escalating dose levels of palacaparib in combination with AZD2265(FPI-2265)
Participants will receive escalating dose levels of palacaparib (AZD9574) once daily in combination with AZD2265 (FPI-2265) once every 6 weeks (Q6W).
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AZD2265 (FPI-2265) will be administered as an intravenous (IV) injection.
Outros nomes:
AZD2287 will be administered as an IV injection.
Palacaparib (AZD9574) will be administered orally.
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Experimental: Sub study 1 Part B(SS1B): selected dose of palacaparib in combination with AZD2265(FPI-2265)
Participants will receive palacaparib (AZD9574) chosen from the DE phase once daily in combination with AZD2265 (FPI-2265) Q6W.
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AZD2265 (FPI-2265) will be administered as an intravenous (IV) injection.
Outros nomes:
AZD2287 will be administered as an IV injection.
Palacaparib (AZD9574) will be administered orally.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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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)
Prazo: Up to approximately 1 year after last dose
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To assess the safety and tolerability of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
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Up to approximately 1 year after last dose
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Part A: Number of participants with dose limiting toxicities (DLTs)
Prazo: From date of first dose up to approximately 2 cycles (up to 3 months)
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To assess the safety and tolerability, and characterise the DLTs of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
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From date of first dose up to approximately 2 cycles (up to 3 months)
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Part B: Number of participants with TEAEs
Prazo: Up to approximately 1 year after last dose
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To further assess the safety and tolerability, and determine the recommended Phase 3 dose (RP3D) of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
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Up to approximately 1 year after last dose
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Part B: Prostate Specific Antigen 50 (PSA50) response rate
Prazo: Up to 3 years 4 months
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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 palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
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Up to 3 years 4 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Part A and Part B: Change from baseline in study-specific biomarker XYZ in response to treatment
Prazo: Up to 3 years 4 months
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To investigate study-specific XYZ expression and relationship to response to the treatment.
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Up to 3 years 4 months
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Part A and Part B: PSA50 response rate
Prazo: Up to 3 years 4 months
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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 palacaparib (AZD9574) in combination with AZD2265 (FPI-2265) (Part A) and to demonstrate effectiveness of AZD2265 (FPI-2265) + palacaparib (AZD9574) relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B).
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Up to 3 years 4 months
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Part A and Part B: Prostate Specific Antigen 90 (PSA90) response rate
Prazo: Up to 3 years 4 months
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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 palacaparib (AZD9574) in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + palacaparib (AZD9574) relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only).
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Up to 3 years 4 months
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Part A and Part B: Time to PSA50 (TTPSA50) response
Prazo: Up to 3 years 4 months
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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 palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
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Up to 3 years 4 months
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Part A and Part B: Time to PSA90 (TTPSA90) response
Prazo: Up to 3 years 4 months
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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 palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
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Up to 3 years 4 months
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Part A and Part B: Duration of PSA50 (DoPSA50) response
Prazo: Up to 3 years 4 months
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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 palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
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Up to 3 years 4 months
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Part A and Part B: Duration of PSA90 (DoPSA90) response
Prazo: Up to 3 years 4 months
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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 palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
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Up to 3 years 4 months
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Part A and Part B: Time to PSA progression
Prazo: Up to 3 years 4 months
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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 palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
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Up to 3 years 4 months
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Part A and Part B: PSA over time
Prazo: Up to 3 years 4 months
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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 palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
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Up to 3 years 4 months
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Part A and Part B: Radiographic Progression-free survival (rPFS)
Prazo: From Day 1 to 3 years 4 months
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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 palacaparib (AZD9574) in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + palacaparib (AZD9574) relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only).
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From Day 1 to 3 years 4 months
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Part A and Part B: Overall Response Rate (ORR)
Prazo: From Day 1 to 3 years 4 months
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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 palacaparib (AZD9574) in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + palacaparib (AZD9574) relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only).
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From Day 1 to 3 years 4 months
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Part A and Part B: Best Overall Response (BOR)
Prazo: From Day 1 to 3 years 4 months
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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 palacaparib (AZD9574) in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + palacaparib (AZD9574) relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only).
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From Day 1 to 3 years 4 months
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Part A and Part B: Duration of response (DoR)
Prazo: From Day 1 to 3 years 4 months
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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 palacaparib (AZD9574) in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + palacaparib (AZD9574) relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only).
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From Day 1 to 3 years 4 months
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Part A and Part B: Time to Response (TTR)
Prazo: From Day 1 to 3 years 4 months
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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 palacaparib (AZD9574) in combination with AZD2265 (FPI-2265) (Part A and Part B) and to demonstrate effectiveness of AZD2265 (FPI-2265) + palacaparib (AZD9574) relative to AZD2265 (FPI-2265) alone and relative to docetaxel (Part B only).
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From Day 1 to 3 years 4 months
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Part A: Disease control rate (DCR)
Prazo: From Day 1 to 3 years 4 months
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To assess the anti-tumour activity of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265)
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From Day 1 to 3 years 4 months
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Part A and Part B: Percentage change in tumour size
Prazo: From Day 1 to 3 years 4 months
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To assess the anti-tumour activity of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
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From Day 1 to 3 years 4 months
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Part A and Part B: Plasma concentration of palacaparib (AZD9574)
Prazo: From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
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To determine the PK of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
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From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
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Part A and Part B: Plasma concentration of AZD2265 (FPI-2265)
Prazo: From Cycle 1 Day 1 to Cycle 2 Day 1 (each cycle will be 42 days)
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To determine the PK of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
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From Cycle 1 Day 1 to Cycle 2 Day 1 (each cycle will be 42 days)
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Part A and Part B: Area under the concentration time curve (AUC)
Prazo: From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
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To determine the PK (AUC) of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
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From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
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Part A and Part B: Maximum observed drug concentration (Cmax)
Prazo: From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
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To determine the PK (Cmax) of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
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From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
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Part A and Part B: Time to reach Cmax (tmax)
Prazo: From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
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To determine the PK (tmax) of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
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From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
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Part A and Part B: Terminal elimination half-life (t½λz)
Prazo: From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
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To determine the PK (t½λz) of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265).
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From Cycle 1 Day 1 to Cycle 2 Day 15 (each cycle will be 42 days)
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Part A and Part B: Change from baseline in study-specific biomarker ABC in response to treatment
Prazo: Up to 3 years 4 months
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To investigate pharmacodynamics of palacaparib (AZD9574) in combination with AZD2265 (FPI-2265) (for Part A and Part B) and of AZD2265 (FPI-2265) monotherapy (for Part B only).
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Up to 3 years 4 months
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
3 de junho de 2026
Conclusão Primária (Estimado)
25 de setembro de 2029
Conclusão do estudo (Estimado)
25 de setembro de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
11 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de maio de 2026
Primeira postagem (Real)
15 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
27 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Genitais
- Neoplasias Genitais Masculinas
- Neoplasias urogenitais
- Neoplasias por local
- Neoplasias
- Doenças Genitais, Masculino
- Doenças prostáticas
- Doenças Urogenitais Masculinas
- Neoplasias prostáticas
- Produtos químicos orgânicos
- Hidrocarbonetos
- Cicloparaffinas
- Hidrocarbonetos, aliciclicos
- Hidrocarbonetos, cíclicos
- Terpenos
- Taxóides
- Ciclodecanos
- Diterpenos
- Docetaxel
Outros números de identificação do estudo
- D7642C00001
- 2025 (Concessão/Contrato do NIH dos EUA: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-524920-23 (Outro identificador: EU CT number)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de 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.
Critérios de acesso de compartilhamento 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 de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .