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Avaliar a eficácia e a segurança do selumetinibe em combinação com docetaxel em pacientes recebendo tratamento de 2ª linha para v-Ki-ras2 Sarcoma de Kirsten Rat Oncogene Homólogo Viral (KRAS) NSCLC positivo (SELECT-1)

6 de novembro de 2026 atualizado por: AstraZeneca

Um estudo de Fase III, duplo-cego, randomizado, controlado por placebo para avaliar a eficácia e a segurança de Selumetinibe (AZD6244; ARRY-142886) (Hyd-Sulfate) em combinação com docetaxel, em pacientes recebendo tratamento de segunda linha para mutação KRAS positiva Câncer de Pulmão de Células Não Pequenas Localmente Avançado ou Metastático (Estágio IIIB - IV) (SELECIONE 1)

The purpose of this study is to assess the efficacy of selumetinib in combination with docetaxel (75mg/m2) vs placebo in combination with docetaxel (75mg/m2) in patients with locally advance or metastatic NSCLCs that harbor mutations of KRAS. This study will also assess the PK, safety, patient reported outcomes (PRO) and tolerability profile of the selumetinib/docetaxel combination, compared to placebo in combination with docetaxel

Visão geral do estudo

Status

Ativo, não recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

A Phase III, Double-Blind, Randomised, Placebo-Controlled Study to Assess the Efficacy and Safety of Selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in Combination with Docetaxel, in Patients receiving second line treatment for KRAS Mutation-Positive Locally Advanced or Metastatic Non Small Cell Lung Cancer (Stage IIIB - IV) (SELECT-1)

Tipo de estudo

Intervencional

Inscrição (Real)

510

Estágio

  • Fase 3

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.

Locais de estudo

  • Alemanha
      • Augsburg, Alemanha, 86156
        • Research Site
      • Bad Berka, Alemanha, 99437
        • Research Site
      • Cologne, Alemanha, 50937
        • Research Site
      • Dortmund, Alemanha, 44309
        • Research Site
      • Gerlingen, Alemanha, 70839
        • Research Site
      • Großhansdorf, Alemanha, 22927
        • Research Site
      • Halle, Alemanha, 06120
        • Research Site
      • Heidelberg, Alemanha, 69126
        • Research Site
      • Homburg, Alemanha, 66424
        • Research Site
      • Löwenstein, Alemanha, 74245
        • Research Site
      • Moers, Alemanha, 47441
        • Research Site
      • München, Alemanha, 81925
        • Research Site
      • Ulm, Alemanha, 89081
        • Research Site
      • Wiesbaden, Alemanha, 65199
        • Research Site
      • Würzburg, Alemanha, 97080
        • Research Site
  • Argentina
      • Buenos Aires, Argentina, 1426
        • Research Site
      • Ciudad de Buenos Aires, Argentina, C1025ABI
        • Research Site
      • Ciudad de Buenos Aires, Argentina, 1180
        • Research Site
      • Córdoba, Argentina, 5000
        • Research Site
      • Rosario, Argentina, S2000KZE
        • Research Site
  • Austrália
      • Camperdown, Austrália, 2050
        • Research Site
      • Chermside, Austrália, 4032
        • Research Site
      • Darlinghurst, Austrália, 2010
        • Research Site
      • Fitzroy, Austrália, 3065
        • Research Site
      • Kogarah, Austrália, 2217
        • Research Site
      • Kurralta Park, Austrália, 5037
        • Research Site
      • Malvern, Austrália, 3144
        • Research Site
      • Wendouree, Austrália, 3355
        • Research Site
      • Woodville South, Austrália, 5011
        • Research Site
  • Brasil
      • Barretos, Brasil, 14784-400
        • Research Site
      • Ijuí, Brasil, 98700-000
        • Research Site
      • Pelotas, Brasil, 096015-280
        • Research Site
      • Porto Alegre, Brasil, 90035-003
        • Research Site
      • Porto Alegre, Brasil, 90610-000
        • Research Site
      • São José do Rio Preto, Brasil, 15090-000
        • Research Site
      • São Paulo, Brasil
        • Research Site
      • São Paulo, Brasil, 01209-000
        • Research Site
      • São Paulo, Brasil, 01246-000
        • Research Site
  • Bulgária
      • Plovdiv, Bulgária, 4000
        • Research Site
      • Sofia, Bulgária, 1233
        • Research Site
      • Sofia, Bulgária, 1330
        • Research Site
      • Sofia, Bulgária, 1303
        • Research Site
      • Varna, Bulgária, 9010
        • Research Site
      • Vratsa, Bulgária, 3000
        • Research Site
  • Bélgica
      • Brussels, Bélgica, 1000
        • Research Site
      • Brussels, Bélgica, 1090
        • Research Site
      • Brussels, Bélgica, 1200
        • Research Site
      • Ghent, Bélgica, 9000
        • Research Site
      • Leuven, Bélgica, 3000
        • Research Site
      • Roeselare, Bélgica, 8800
        • Research Site
  • Canadá
    • Alberta
      • Edmonton, Alberta, Canadá, T6G 1Z2
        • Research Site
    • British Columbia
      • Kelowna, British Columbia, Canadá, V1Y 5L3
        • Research Site
      • Surrey, British Columbia, Canadá, V3V 1Z2
        • Research Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canadá, B3H 1V7
        • Research Site
    • Ontario
      • Oshawa, Ontario, Canadá, L1G 2B9
        • Research Site
      • Toronto, Ontario, Canadá, M5G 2M9
        • Research Site
    • Quebec
      • Montreal, Quebec, Canadá, H4A 3J1
        • Research Site
      • Québec, Quebec, Canadá, G1V 4G5
        • Research Site
    • Saskatchewan
      • Regina, Saskatchewan, Canadá, S4T 7T1
        • Research Site
      • Saskatoon, Saskatchewan, Canadá, S7N 4H4
        • Research Site
  • Chile
      • Santiago, Chile, 7520349
        • Research Site
      • Santiago, Chile, 8360160
        • Research Site
      • Santiago, Chile, 7500921
        • Research Site
      • Santiago, Chile, 8380456
        • Research Site
      • Santiago, Chile, 8420383
        • Research Site
      • Santiago, Chile, 7630370
        • Research Site
  • Espanha
      • Barcelona, Espanha, 08003
        • Research Site
      • Madrid, Espanha, 28034
        • Research Site
      • Madrid, Espanha, 28041
        • Research Site
      • Madrid, Espanha, 08035
        • Research Site
      • Málaga, Espanha, 29010
        • Research Site
      • Seville, Espanha, 41013
        • Research Site
      • Vigo(Pontevedra), Espanha, 36204
        • Research Site
      • Zaragoza, Espanha, 50009
        • Research Site
  • Estados Unidos
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80045
        • Research Site
    • Florida
      • Pembroke Pines, Florida, Estados Unidos, 33028
        • Research Site
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30318
        • Research Site
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60637
        • Research Site
    • Louisiana
      • Metairie, Louisiana, Estados Unidos, 70006
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02114
        • Research Site
      • Boston, Massachusetts, Estados Unidos, 02215
        • Research Site
      • Danvers, Massachusetts, Estados Unidos, 01923
        • Research Site
    • New York
      • New York, New York, Estados Unidos, 10032
        • Research Site
      • New York, New York, Estados Unidos, 10011
        • Research Site
    • North Carolina
      • Durham, North Carolina, Estados Unidos, 27710
        • Research Site
    • Pennsylvania
      • Hershey, Pennsylvania, Estados Unidos, 17033
        • Research Site
      • Philadelphia, Pennsylvania, Estados Unidos, 19107
        • Research Site
    • Tennessee
      • Nashville, Tennessee, Estados Unidos, 37203
        • Research Site
      • Nashville, Tennessee, Estados Unidos, 37232
        • Research Site
    • Washington
      • Seattle, Washington, Estados Unidos, 98104
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, Estados Unidos, 26506
        • Research Site
  • França
      • Brest, França, 29609
        • Research Site
      • Caen, França, F-14033
        • Research Site
      • Clermont-Ferrand, França, 63003
        • Research Site
      • Dijon, França, 21079
        • Research Site
      • Lille, França, 59000
        • Research Site
      • Marseille, França, 13915
        • Research Site
      • Paris, França, 75020
        • Research Site
      • Pierre-Bénite, França, 69310
        • Research Site
      • Rennes, França, 35033
        • Research Site
      • Toulouse, França, 31059
        • Research Site
  • Holanda
      • 's-Hertogenbosch, Holanda, 5223 GZ
        • Research Site
      • Amsterdam, Holanda, 1066 CX
        • Research Site
      • Amsterdam, Holanda, 1081 HV
        • Research Site
      • Bergen op Zoom, Holanda, 4624 VT
        • Research Site
      • Maastricht, Holanda, 6202 AZ
        • Research Site
  • Hungria
      • Budapest, Hungria, 1121
        • Research Site
      • Budapest, Hungria, 1122
        • Research Site
      • Edelény, Hungria, 3780
        • Research Site
      • Győr, Hungria, 9024
        • Research Site
      • Kaposvár, Hungria, 7400
        • Research Site
      • Miskolc, Hungria, 3529
        • Research Site
      • Nyíregyháza, Hungria, 4400
        • Research Site
      • Törökbálint, Hungria, 2045
        • Research Site
  • Israel
      • Beersheba, Israel, 8410101
        • Research Site
      • Haifa, Israel, 31096
        • Research Site
      • Kfar Saba, Israel, 4428164
        • Research Site
      • Petah Tikva, Israel, 49100
        • Research Site
      • Tel Aviv, Israel, 64239
        • Research Site
      • Tel HaShomer, Israel, 52621
        • Research Site
  • Itália
      • Bari, Itália, 70124
        • Research Site
      • Genova, Itália, 16100
        • Research Site
      • Livorno, Itália, 57100
        • Research Site
      • Milan, Itália, 20132
        • Research Site
      • Naples, Itália, 80131
        • Research Site
      • Orbassano, Itália, 10043
        • Research Site
      • Parma, Itália, 43126
        • Research Site
      • Perugia, Itália, 06132
        • Research Site
      • Roma, Itália, 00128
        • Research Site
      • Roma, Itália, 00144
        • Research Site
  • México
      • Monterrey, México, 64460
        • Research Site
      • México, México, 14080
        • Research Site
  • Peru
      • Lima, Peru, 15033
        • Research Site
      • Lima, Peru, L27
        • Research Site
      • Lima, Peru, LIMA 34
        • Research Site
      • Lima, Peru, LIMA 01
        • Research Site
      • Lima, Peru, LIMA 29
        • Research Site
      • Lima, Peru, LIMA 11
        • Research Site
      • Lima, Peru, 15073
        • Research Site
      • Miraflores, Peru, 15046
        • Research Site
  • Polônia
      • Brzozów, Polônia, 36-200
        • Research Site
      • Bydgoszcz, Polônia, 85-796
        • Research Site
      • Gdansk, Polônia, 80-952
        • Research Site
      • Gdansk, Polônia, 80-219
        • Research Site
      • Grudziądz, Polônia, 86-300
        • Research Site
      • Krakow, Polônia, 31-202
        • Research Site
      • Lubin, Polônia, 59-301
        • Research Site
      • Olsztyn, Polônia, 10-357
        • Research Site
      • Opole, Polônia, 45-061
        • Research Site
      • Sucha Beskidzka, Polônia, 34-200
        • Research Site
      • Szczecin, Polônia, 70-891
        • Research Site
      • Warsaw, Polônia, 02-781
        • Research Site
  • Portugal
      • Amadora, Portugal, 2720-276
        • Research Site
      • Coimbra, Portugal, 3040-316
        • Research Site
      • Lisbon, Portugal, 1769-001
        • Research Site
      • Lisbon, Portugal, 1099-023
        • Research Site
      • Porto, Portugal, 4200-319
        • Research Site
      • Porto, Portugal, 4100-180
        • Research Site
      • Vila Nova de Gaia, Portugal, 4434-502
        • Research Site
  • Reino Unido
      • Aberdeen, Reino Unido, AB2 2ZB
        • Research Site
      • London, Reino Unido, SW3 6JJ
        • Research Site
      • Manchester, Reino Unido, M20 4BX
        • Research Site
      • Nottingham, Reino Unido, NG5 1PB
        • Research Site
      • Sutton, Reino Unido, SM2 5PT
        • Research Site
      • Wolverhampton, Reino Unido, WV10 0QP
        • Research Site
  • Romênia
      • Cluj-Napoca, Romênia, 400015
        • Research Site
      • Cluj-Napoca, Romênia, 400058
        • Research Site
  • Rússia
      • Kazan', Rússia, 420012
        • Research Site
      • Moscow, Rússia, 115478
        • Research Site
      • Moscow, Rússia, 105229
        • Research Site
      • Saint Petersburg, Rússia, 197758
        • Research Site
      • Saint Petersburg, Rússia, 194291
        • Research Site
      • Saint Petersburg, Rússia, 197342
        • Research Site
      • Volgograd, Rússia, 400138
        • Research Site
  • Suécia
      • Linköping, Suécia, 581 85
        • Research Site
      • Uppsala, Suécia, SE-751 85
        • Research Site
      • Örebro, Suécia, 701 85
        • Research Site
  • Turquia (Türkiye)
      • Ankara, Turquia (Türkiye), 06230
        • Research Site
      • Ankara, Turquia (Türkiye), 06280
        • Research Site
      • Istanbul, Turquia (Türkiye), 34662
        • Research Site
      • Istanbul, Turquia (Türkiye), 34844
        • Research Site
      • Izmir, Turquia (Türkiye), 35100
        • Research Site
      • Izmir, Turquia (Türkiye), 35110
        • Research Site
      • Manisa, Turquia (Türkiye), 45030
        • Research Site
  • Ucrânia
      • Chernivtsі, Ucrânia, 58013
        • Research Site
      • Dnipro, Ucrânia, 49102
        • Research Site
      • Kharkiv Region, Ucrânia, 61070
        • Research Site
      • Kryvyi Rih, Ucrânia, 50048
        • Research Site
      • Kyiv, Ucrânia, 03115
        • Research Site
      • Sumy, Ucrânia, 40022
        • Research Site
      • Uzhhorod, Ucrânia, 88000
        • Research Site
      • Zaporizhzhya, Ucrânia, 69040
        • Research Site
  • Áustria
      • Innsbruck, Áustria, 6020
        • Research Site
      • Linz, Áustria, 4020
        • Research Site
      • Salzburg, Áustria, 5020
        • Research Site
      • Vienna, Áustria, 1160
        • Research Site
      • Vienna, Áustria, 1100
        • Research Site

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

18 anos a 130 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Provision of signed, written and dated informed consent prior to any study specific procedures
  • Male or female, aged 18 years or older
  • Histological or cytological confirmation of locally advanced or metastatic NSCLC (IIIB-IV)
  • KRAS mutation positive tumour sample as determined by the designated testing laboratory
  • Failure of 1st line anti-cancer therapy due to radiological documentation of disease progression in advanced disease or subsequent relapse of disease following 1st line therapy

Exclusion Criteria:

  • Mixed small cell and non-small cell lung cancer histology.
  • Received >1 prior anti-cancer drug regimen for advanced or metastatic NSCLC. Patients who develop disease progression while on switch maintenance therapy (maintenance using an agent not in the first-line regimen) will not be eligible.
  • Receiving or have received systemic anti-cancer therapy within 30 days prior to starting study treatment
  • Other concomitant anti-cancer therapy agents excepts steroids
  • Prior treatment with a Mitogen-Activated protein Kinase (MEK) inhibitor or any docetaxel-containing regimen (prior treatment with paclitaxel is acceptable).
  • Last radiation therapy within 4 weeks prior starting study treatment, or limited field of radiation for palliation within 7 days of the first dose of study treatment

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 Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Selumetinib + Docetaxel

Three 25mg Selumetinib capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle
Medicamento: Selumetinib

Three 25 mg selumetinib capsules (Hyd-Sulfate) be administered orally, twice daily, (total dose 75 mg dose bd) on an uninterrupted schedule.

Outros nomes:
  • AZD6244; ARRY-142886
Medicamento: Docetaxel

Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.

Medicamento: Pegylated G-CSF

All patients will receive pegylated Granulocyte Colony Stimulating Factor (G-CSF) at least 24 hours after administration of every docetaxel dose and not within 14 days prior to the next docetaxel administration.

Outros nomes:
  • Pegfilgrastim 6 mg
Experimental: Placebo + Docetaxel

Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
Medicamento: Docetaxel

Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.

Medicamento: Pegylated G-CSF

All patients will receive pegylated Granulocyte Colony Stimulating Factor (G-CSF) at least 24 hours after administration of every docetaxel dose and not within 14 days prior to the next docetaxel administration.

Outros nomes:
  • Pegfilgrastim 6 mg
Medicamento: Placebo

Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Progression-Free Survival (PFS)
Prazo: Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)

Progression free survival is defined as the time from randomisation until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Overall Survival (OS)
Prazo: Measured at baseline until date of death due to any cause. Estimated final completion : approximately 3.5 years after FSI

Overall Survival is defined as the time from the date of randomisation until death due to any cause.
Measured at baseline until date of death due to any cause. Estimated final completion : approximately 3.5 years after FSI
Objective Response Rate (ORR)
Prazo: Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)

ORR is defined as the number (%) of subjects with at least one overall visit response of complete response (CR) or partial response (PR). Per RECIST v1.1 for target lesions and assessed by CT/MRI: CR - disappearance of all target lesions; PR - >=30% decrease in the sum of the longest diameter of target lesion. (Non-target lesion and new lesion results are also taken into account for the overall visit result)
Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
Duration of Response (DoR)
Prazo: Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)

Duration of response is defined as the time from the date of first documented response until the date of objective disease progression (RECIST 1.1) or death (by any cause in the absence of progression)
Measured at baseline until the date of first documented objective disease progression. Estimated final completion : approximately 3 years after first subject in (FSI)
Symptom Improvement Rate Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)
Prazo: Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)

The symptom improvement rate will be defined as the number (%) of patients with two consecutive assessments at least 18 days apart (ie 21 days allowing a visit window of 3 days) which showed a clinically meaningful improvement in symptoms from baseline (defined as a decrease in the ASBI from baseline ≥10). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.
Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)
Time to Symptom Progression Using Average Symptom Burden Index (ASBI) of the Lung Cancer Symptom Scale (LCSS)
Prazo: Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)

Time to symptom progression will be defined as the time from randomization until the date of first clinically meaningful symptom deterioration (defined as an increase in the ASBI from baseline ≥10), or death (by any cause). LCSS-Lung Cancer Symptom Scale; ASBI-Average symptom burden index.
Measured from date of randomisation until 30 days post treatment discontinuation or 30 days post progression (if study treatment is discontinued before progression). Estimated final completion : approximately 3 years after first subject in (FSI)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

AstraZeneca

Investigadores

  • Investigador principal: Pasi Jänne, MD, Dana-Faber Cancer Institute, USA
  • Cadeira de estudo: Gabriella Mariani, MD, AstraZeneca UK, MSD

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Links úteis

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)

25 de setembro de 2013

Conclusão Primária (Real)

7 de junho de 2016

Conclusão do estudo (Estimado)

31 de dezembro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

29 de agosto de 2013

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de agosto de 2013

Primeira postagem (Estimado)

2 de setembro de 2013

Atualizações de registro de estudo

Última Atualização Postada (Real)

9 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • D1532C00079
  • 2013-001676-38 (Número EudraCT)

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. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Prazo de Compartilhamento de IPD

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma 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 de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA

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 .

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