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

2. juli 2012 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

217

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: B
Medicin: 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.
Eksperimentel: EN
Medicin: 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.
Andre navne:
  • Sutent, sunitinib malate

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Progression-Free Survival (PFS)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of Participants With Objective Response
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2006

Primær færdiggørelse (Faktiske)

1. maj 2010

Studieafslutning (Faktiske)

1. juni 2011

Datoer for studieregistrering

Først indsendt

27. oktober 2005

Først indsendt, der opfyldte QC-kriterier

27. oktober 2005

Først opslået (Skøn)

30. oktober 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

12. juli 2012

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juli 2012

Sidst verificeret

1. juli 2012

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • A6181077

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner