Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Study Of SU011248 Versus Chemotherapy For Patients With Previously Treated Triple Receptor Negative Breast Cancer

2 de julho de 2012 atualizado por: Pfizer

A Randomized Phase 2 Study Of SU011248 Versus Standard-Of-Care For Patients With Previously Treated, Advanced, Triple Receptor Negative (ER, PR, HER2) Breast Cancer

The purpose of this study is to compare progression free survival for SU011248 [sutent (sunitinib malate)] versus standard of care therapy in patients with previously treated, advanced, triple receptor negative (ER, PR, HER2) locally recurrent or metastatic breast cancer.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Real)

217

Estágio

  • Fase 2

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
      • Berlin, Alemanha, 10177
        • Pfizer Investigational Site
  • Bulgária
      • Sofia, Bulgária, 1233
        • Pfizer Investigational Site
      • Sofia, Bulgária, 1527
        • Pfizer Investigational Site
      • Sofia, Bulgária, 1756
        • Pfizer Investigational Site
      • Stara Zagora, Bulgária, 6000
        • Pfizer Investigational Site
      • Varna, Bulgária, 9000
        • Pfizer Investigational Site
  • Canadá
    • Alberta
      • Edmonton, Alberta, Canadá, T6G 1Z2
        • Pfizer Investigational Site
    • Ontario
      • Toronto, Ontario, Canadá, M4N 3M5
        • Pfizer Investigational Site
  • Espanha
      • Barcelona, Espanha, 08035
        • Pfizer Investigational Site
      • Gerona, Espanha, 17007
        • Pfizer Investigational Site
      • Lleida, Espanha, 25198
        • Pfizer Investigational Site
      • Malaga, Espanha, 29010
        • Pfizer Investigational Site
      • Sevilla, Espanha, 41013
        • Pfizer Investigational Site
  • Estados Unidos
    • California
      • Corona, California, Estados Unidos, 92879
        • Pfizer Investigational Site
      • Fullerton, California, Estados Unidos, 92835
        • Pfizer Investigational Site
      • Glendora, California, Estados Unidos, 91741
        • Pfizer Investigational Site
      • Los Angeles, California, Estados Unidos, 90095-1772
        • Pfizer Investigational Site
      • Los Angeles, California, Estados Unidos, 90095-7423
        • Pfizer Investigational Site
      • Los Angeles, California, Estados Unidos, 90095
        • Pfizer Investigational Site
      • Mission Hills, California, Estados Unidos, 91345
        • Pfizer Investigational Site
      • Northridge, California, Estados Unidos, 91325
        • Pfizer Investigational Site
      • Palm Springs, California, Estados Unidos, 92262-4885
        • Pfizer Investigational Site
      • Pasadena, California, Estados Unidos, 91105
        • Pfizer Investigational Site
      • Pomona, California, Estados Unidos, 91767
        • Pfizer Investigational Site
      • Rancho Cucamonga, California, Estados Unidos, 91730
        • Pfizer Investigational Site
      • Santa Monica, California, Estados Unidos, 90404
        • Pfizer Investigational Site
      • Valencia, California, Estados Unidos, 91355
        • Pfizer Investigational Site
      • West Covina, California, Estados Unidos, 91790
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80010
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, Estados Unidos, 20010
        • Pfizer Investigational Site
    • Florida
      • Boca Raton, Florida, Estados Unidos, 33428
        • Pfizer Investigational Site
      • Gainesville, Florida, Estados Unidos, 32605-4391
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30341
        • Pfizer Investigational Site
      • Atlanta, Georgia, Estados Unidos, 30342
        • Pfizer Investigational Site
      • Decatur, Georgia, Estados Unidos, 30033
        • Pfizer Investigational Site
      • Macon, Georgia, Estados Unidos, 31217
        • Pfizer Investigational Site
      • Marietta, Georgia, Estados Unidos, 30060
        • Pfizer Investigational Site
      • Tucker, Georgia, Estados Unidos, 30084
        • Pfizer Investigational Site
    • Illinois
      • Zion, Illinois, Estados Unidos, 60099
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Pfizer Investigational Site
    • Michigan
      • Bloomfield Hills, Michigan, Estados Unidos, 48302
        • Pfizer Investigational Site
      • Brownstown, Michigan, Estados Unidos, 48183
        • Pfizer Investigational Site
      • Dearborn, Michigan, Estados Unidos, 48126
        • Pfizer Investigational Site
      • Detroit, Michigan, Estados Unidos, 48202
        • Pfizer Investigational Site
      • West Bloomfield, Michigan, Estados Unidos, 48322
        • Pfizer Investigational Site
    • Mississippi
      • Biloxi, Mississippi, Estados Unidos, 39532
        • Pfizer Investigational Site
    • Missouri
      • Clarkson Valley, Missouri, Estados Unidos, 63011
        • Pfizer Investigational Site
      • St. Louis, Missouri, Estados Unidos, 63141
        • Pfizer Investigational Site
      • St. Louis, Missouri, Estados Unidos, 63109
        • Pfizer Investigational Site
    • New Jersey
      • Midland Park, New Jersey, Estados Unidos, 07432
        • Pfizer Investigational Site
      • Morristown, New Jersey, Estados Unidos, 07962
        • Pfizer Investigational Site
      • Paramus, New Jersey, Estados Unidos, 07652
        • Pfizer Investigational Site
      • Pompton Plains, New Jersey, Estados Unidos, 07444
        • Pfizer Investigational Site
      • Ridgewood, New Jersey, Estados Unidos, 07450
        • Pfizer Investigational Site
      • Summit, New Jersey, Estados Unidos, 07902
        • Pfizer Investigational Site
      • Westwood, New Jersey, Estados Unidos, 07675
        • Pfizer Investigational Site
    • New York
      • Bronx, New York, Estados Unidos, 10451
        • Pfizer Investigational Site
      • Bronx, New York, Estados Unidos, 10461
        • Pfizer Investigational Site
    • North Carolina
      • Clinton, North Carolina, Estados Unidos, 28388
        • Pfizer Investigational Site
      • Goldsboro, North Carolina, Estados Unidos, 27534
        • Pfizer Investigational Site
      • Wilson, North Carolina, Estados Unidos, 27893
        • Pfizer Investigational Site
    • Oklahoma
      • Del City, Oklahoma, Estados Unidos, 73115
        • Pfizer Investigational Site
    • Pennsylvania
      • Greensburg, Pennsylvania, Estados Unidos, 15601
        • Pfizer Investigational Site
      • Hershey, Pennsylvania, Estados Unidos, 17033-0850
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Estados Unidos, 15213
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Estados Unidos, 15232-1305
        • Pfizer Investigational Site
      • Wexford, Pennsylvania, Estados Unidos, 15090
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, Estados Unidos, 38104
        • Pfizer Investigational Site
      • Memphis, Tennessee, Estados Unidos, 38120
        • Pfizer Investigational Site
      • Memphis, Tennessee, Estados Unidos, 38133
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, Estados Unidos, 75230-2510
        • Pfizer Investigational Site
      • Dallas, Texas, Estados Unidos, 75230
        • Pfizer Investigational Site
      • Fort Worth, Texas, Estados Unidos, 76177
        • Pfizer Investigational Site
      • Houston, Texas, Estados Unidos, 77024
        • Pfizer Investigational Site
      • Houston, Texas, Estados Unidos, 77055
        • Pfizer Investigational Site
      • Plano, Texas, Estados Unidos, 75093
        • Pfizer Investigational Site
      • Plano, Texas, Estados Unidos, 75075
        • Pfizer Investigational Site
      • Richardson, Texas, Estados Unidos, 75080
        • Pfizer Investigational Site
      • San Antonio, Texas, Estados Unidos, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, Estados Unidos, 78207
        • Pfizer Investigational Site
      • San Antonio, Texas, Estados Unidos, 78217
        • Pfizer Investigational Site
      • San Antonio, Texas, Estados Unidos, 78258
        • Pfizer Investigational Site
      • San Atonio, Texas, Estados Unidos, 78229
        • Pfizer Investigational Site
      • Tyler, Texas, Estados Unidos, 75702
        • Pfizer Investigational Site
    • Washington
      • Federal Way, Washington, Estados Unidos, 98003
        • Pfizer Investigational Site
      • Lakewood, Washington, Estados Unidos, 98499
        • Pfizer Investigational Site
      • Puyallup, Washington, Estados Unidos, 98372
        • Pfizer Investigational Site
      • Seattle, Washington, Estados Unidos, 98104
        • Pfizer Investigational Site
      • Seattle, Washington, Estados Unidos, 98122
        • Pfizer Investigational Site
      • Tacoma, Washington, Estados Unidos, 98405
        • Pfizer Investigational Site
  • França
      • BESANCON Cedex 5, França, 25052
        • Pfizer Investigational Site
      • BESANCON cedex, França, 25030
        • Pfizer Investigational Site
      • NANTES cedex, França, 44805
        • Pfizer Investigational Site
      • Paris Cedex 20, França, 75970
        • Pfizer Investigational Site
  • Hungria
      • Budapest, Hungria, 1082
        • Pfizer Investigational Site
      • Budapest, Hungria, 1122
        • Pfizer Investigational Site
  • Itália
      • Aviano (PN), Itália, 33081
        • Pfizer Investigational Site
      • Milano, Itália, 20100
        • Pfizer Investigational Site
      • Prato, FI, Itália, 59100
        • Pfizer Investigational Site
  • Peru
    • Balcali
      • Adana, Balcali, Peru, 01330
        • Pfizer Investigational Site
    • Besevler
      • Ankara, Besevler, Peru, 06510
        • Pfizer Investigational Site
    • Pendik
      • Istanbul, Pendik, Peru, 34890
        • Pfizer Investigational Site
    • Sihhiye
      • Ankara, Sihhiye, Peru, 06100
        • Pfizer Investigational Site
  • Reino Unido
      • Edinburgh, Reino Unido, EH4 2XU
        • Pfizer Investigational Site
      • Oxfordshire, Reino Unido, OX3 7LJ
        • Pfizer Investigational Site
      • Southampton, Reino Unido, SO16 6YD
        • Pfizer Investigational Site
  • República Checa
      • Brno, República Checa, 656 91
        • Pfizer Investigational Site
      • Praha 8, República Checa, 180 00
        • Pfizer Investigational Site
    • Ceska Republika
      • Brno, Ceska Republika, República Checa, 656 91
        • Pfizer Investigational Site
      • Praha 8, Ceska Republika, República Checa, 180 81
        • Pfizer Investigational Site
  • Ucrânia
      • Dnipropetrovsk, Ucrânia, 49102
        • Pfizer Investigational Site
      • Kyiv, Ucrânia, 03115
        • Pfizer Investigational Site
      • Odessa, Ucrânia, 65055
        • Pfizer Investigational 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 e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Recurrent or metastatic breast cancer
  • Estrogen receptor (ER), progestin receptor (PR) and HER2/neu receptor (HER2) negative status
  • Prior treatment with an anthracycline and a taxane in the adjuvant or advanced disease setting
  • Relapse following adjuvant chemotherapy within 6 months of last treatment and/or received one or two chemotherapy regimens for advanced disease

Exclusion Criteria:

  • More than two chemotherapy regimens for advanced disease
  • Uncontrolled/symptomatic spread of cancer to the brain

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: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: B
Medicamento: Chemotherapy

The choice of chemotherapy will be at the discretion of the investigator within the limits outlined below.

  1. Capecitabine - 1000-1250 mg/m2 twice daily days 1-14 every 3 weeks
  2. Vinorelbine - 25-30 mg/m2 rapid intravenous infusion or 60-80 mg/m2 oral weekly, expressed in 3-week cycles
  3. Docetaxel - 75-100 mg/m2 every 3 weeks
  4. Paclitaxel - 175-200 mg/m2 every 3 weeks
  5. Paclitaxel - 80-90 mg/m2 weekly, in a continuous regimen expressed in 3-week cycles or administration of 3 weeks of treatment followed by 1 week of rest. Use of the 3/1 regimen will require extra care in scheduling disease assessments.
  6. Gemcitabine - 800-1250 mg/m2 Days 1 and 8 every 3 weeks Study will continue until disease progression or it is in the best interest of the patient to discontinue based on achievement of maximum benefit or tolerability issues. At the time of progression patients randomized to chemotherapy will be offered crossover to single agent SU011248.
Experimental: UMA
Medicamento: SU011248
SU011248 capsules administered orally, daily in a continuous regimen, 3-week cycles, starting dose of 37.5 mg daily. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity. Dose escalate SU011248 to 50-mg daily if minimal toxicities . Study will continue until disease progression. Patients randomized to or crossed over to SU011248 may continue beyond the time of Response Evaluation Criterion in Solid Tumors (RECIST) -defined progression at the discretion of the investigator in the case of clinical benefit.
Outros nomes:
  • Sutent, sunitinib malate

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Progression-Free Survival (PFS)
Prazo: Baseline, every 6 weeks until disease progression or death (up to 3 years from first dose)
Time in months from start of study treatment to first documentation of objective tumor progression (per RECIST) or death due to any cause. PFS was calculated as (first event date minus first randomization date plus 1) divided by 30.4. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
Baseline, every 6 weeks until disease progression or death (up to 3 years from first dose)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Proportion of Participants With Objective Response
Prazo: Baseline until response or disease progression (up to 3 years from first dose)
Objective response based assessment of confirmed response (CR) or confirmed partial response (PR) according to RECIST. CR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. PR are those with a greater than or equal to (≥) 30% decrease in the sum of the longest dimensions (SLD) of the target lesions taking as a reference the baseline SLD.
Baseline until response or disease progression (up to 3 years from first dose)
Duration of Response (DR)
Prazo: Time from first response to disease progression up to 3 years from first dose
Time in months from the first documentation of objective tumor response (CR or PR) to objective tumor progression or death. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 30.4. DR was calculated for the subgroup of participants with a confirmed objective tumor response.
Time from first response to disease progression up to 3 years from first dose
Survival Probability at 1 Year
Prazo: Baseline until death (up to 3 years after first dose of study medication)
Probability that the participants will survive at end of 1 year from the first dose of study treatment. Calculated using data collected from baseline until death (up to 3 years after first dose of study medication). Probability calculated from Kaplan-Meier estimate.
Baseline until death (up to 3 years after first dose of study medication)
Overall Survival (OS)
Prazo: Baseline until death (up to 3 years after first dose of study medication)
Time in months from the date of randomization to date of death due to any cause. OS was calculated as (date of death minus randomization date plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Baseline until death (up to 3 years after first dose of study medication)
Health Related Quality of Life (HRQoL) and Disease Related Symptoms as Measured by European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QoL) Questionnaire (EORTC-QLQ-C30)
Prazo: Day 1, Cycle 1; Day 1, odd number cycles; and end of treatment (EOT)/withdrawal
EORTC QLQ-C30: global health/QoL, functional domains (physical, role, cognitive, emotional, social), and symptom scales/items (fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea). Recall period: past week; response range: not at all to very much; global/QoL range: very poor to excellent. Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.
Day 1, Cycle 1; Day 1, odd number cycles; and end of treatment (EOT)/withdrawal
HRQoL and Disease Related Symptoms as Measured by EORTC-QLQ-C30 Breast Cancer Module (BR23) Score
Prazo: Day 1, Cycle 1; Day 1, odd number cycles; and EOT/withdrawal
BR23: measured disease related symptoms of dry mouth, eye pain, hair loss, hot flushes, attractiveness, future health, sexual activity, arm/shoulder pain, breast pain, swollen breast, and skin problems on the breast. Recall period: past week; response range: not at all to very much. Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.
Day 1, Cycle 1; Day 1, odd number cycles; and EOT/withdrawal
Observed Plasma Trough Concentrations (Ctrough) of Sunitinib
Prazo: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Ctrough of SU012662 (Metabolite of Sunitinib)
Prazo: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Ctrough of Total Drug (Sunitinib + SU012662)
Prazo: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Dose-corrected Ctrough of Sunitinib
Prazo: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Ctrough = plasma concentration of sunitinib prior to study drug administration, dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.
Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Dose-corrected Ctrough of SU012662 (Metabolite of Sunitinib)
Prazo: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Ctrough = plasma concentration of SU012662 prior to study drug administration, dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.
Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Dose-corrected Ctrough of Total Drug (Sunitinib + SU012662)
Prazo: Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Ctrough = plasma concentration of total drug (Sunitinib + SU012662) prior to study drug administration dose corrected using the following formula Intended Dose/Actual Dose, where Actual Dose: the dose the participant received over the last 10 consecutive days and Intended Dose: the starting dose per study protocol.
Predose Day 1, Cycles 1, 2, 3, 4, 5 and 7 and Day 15 of Cycles 1, 2, and 3
Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 2 (sVEGFR2)
Prazo: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma concentrations of sVEGFR2 were examined as a potential pharmacodynamic marker
Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma Concentration of Soluble Vascular Endothelial Growth Factor Receptor 3 (sVEGFR3)
Prazo: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma concentrations of sVEGFR3 were examined as a potential pharmacodynamic marker
Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma Concentration of Soluble Vascular Endothelial Growth Factor A (sVEGF-A)
Prazo: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma concentrations of sVEGF-A were examined as a potential pharmacodynamic marker
Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5, and 7), and EOT/withdrawal
Plasma Concentration of Soluble Placental Growth Factor (sPlGF)
Prazo: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal
Plasma concentrations of sPlGF were examined as a potential pharmacodynamic marker
Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal
Plasma Concentration of Soluble Kinase Insert Domain for Tyrosine (sKIT), a Stem Cell Factor Receptor
Prazo: Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal
Plasma concentrations of sKIT were examined as a potential pharmacodynamic marker
Baseline (Cycle 1, Day 1), Day 1 (Cycles 2, 3, 4, 5 and 7), and EOT/withdrawal
Circulating Endothelial Cells (CEC)
Prazo: Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal
Blood samples were collected to enumerate the number of total CECs and sVEGFR1, sVEGFR2 and sVEGFR3 protein expression and/or cellular viability.
Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal
Circulating Tumor Cells (CTC)
Prazo: Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal
Blood samples were collected to enumerate the number of total CTCs and insulin growth factor 1R positive (IGF-1R+) CTCs
Days 1 and 15 of Cycles 1, 2 and 3, Day 1 of Cycles 4 and 5, and every odd cycle thereafter, and EOT/withdrawal

Colaboradores e Investigadores

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

Patrocinador

Pfizer

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

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

1 de janeiro de 2006

Conclusão Primária (Real)

1 de maio de 2010

Conclusão do estudo (Real)

1 de junho de 2011

Datas de inscrição no estudo

Enviado pela primeira vez

27 de outubro de 2005

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de outubro de 2005

Primeira postagem (Estimativa)

30 de outubro de 2005

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

12 de julho de 2012

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de julho de 2012

Última verificação

1 de julho de 2012

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • A6181077

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado 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 .

Se inscrever