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

2 de julio de 2012 actualizado 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

217

Fase

  • Fase 2

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania, 10177
        • Pfizer Investigational Site
  • Bulgaria
      • Sofia, Bulgaria, 1233
        • Pfizer Investigational Site
      • Sofia, Bulgaria, 1527
        • Pfizer Investigational Site
      • Sofia, Bulgaria, 1756
        • Pfizer Investigational Site
      • Stara Zagora, Bulgaria, 6000
        • Pfizer Investigational Site
      • Varna, Bulgaria, 9000
        • Pfizer Investigational Site
  • Canadá
    • Alberta
      • Edmonton, Alberta, Canadá, T6G 1Z2
        • Pfizer Investigational Site
    • Ontario
      • Toronto, Ontario, Canadá, M4N 3M5
        • Pfizer Investigational Site
  • España
      • Barcelona, España, 08035
        • Pfizer Investigational Site
      • Gerona, España, 17007
        • Pfizer Investigational Site
      • Lleida, España, 25198
        • Pfizer Investigational Site
      • Malaga, España, 29010
        • Pfizer Investigational Site
      • Sevilla, España, 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
  • Francia
      • BESANCON Cedex 5, Francia, 25052
        • Pfizer Investigational Site
      • BESANCON cedex, Francia, 25030
        • Pfizer Investigational Site
      • NANTES cedex, Francia, 44805
        • Pfizer Investigational Site
      • Paris Cedex 20, Francia, 75970
        • Pfizer Investigational Site
  • Hungría
      • Budapest, Hungría, 1082
        • Pfizer Investigational Site
      • Budapest, Hungría, 1122
        • Pfizer Investigational Site
  • Italia
      • Aviano (PN), Italia, 33081
        • Pfizer Investigational Site
      • Milano, Italia, 20100
        • Pfizer Investigational Site
      • Prato, FI, Italia, 59100
        • Pfizer Investigational Site
  • Pavo
    • Balcali
      • Adana, Balcali, Pavo, 01330
        • Pfizer Investigational Site
    • Besevler
      • Ankara, Besevler, Pavo, 06510
        • Pfizer Investigational Site
    • Pendik
      • Istanbul, Pendik, Pavo, 34890
        • Pfizer Investigational Site
    • Sihhiye
      • Ankara, Sihhiye, Pavo, 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
  • Ucrania
      • Dnipropetrovsk, Ucrania, 49102
        • Pfizer Investigational Site
      • Kyiv, Ucrania, 03115
        • Pfizer Investigational Site
      • Odessa, Ucrania, 65055
        • Pfizer Investigational Site

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: B
Droga: 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: A
Droga: 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.
Otros nombres:
  • Sutent, sunitinib malate

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-Free Survival (PFS)
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of Participants With Objective Response
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Pfizer

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2006

Finalización primaria (Actual)

1 de mayo de 2010

Finalización del estudio (Actual)

1 de junio de 2011

Fechas de registro del estudio

Enviado por primera vez

27 de octubre de 2005

Primero enviado que cumplió con los criterios de control de calidad

27 de octubre de 2005

Publicado por primera vez (Estimar)

30 de octubre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

12 de julio de 2012

Última actualización enviada que cumplió con los criterios de control de calidad

2 de julio de 2012

Última verificación

1 de julio de 2012

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • A6181077

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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