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

2 luglio 2012 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

217

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Sperimentale: UN
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.
Altri nomi:
  • Sutent, sunitinib malate

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-Free Survival (PFS)
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of Participants With Objective Response
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Pfizer

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2006

Completamento primario (Effettivo)

1 maggio 2010

Completamento dello studio (Effettivo)

1 giugno 2011

Date di iscrizione allo studio

Primo inviato

27 ottobre 2005

Primo inviato che soddisfa i criteri di controllo qualità

27 ottobre 2005

Primo Inserito (Stima)

30 ottobre 2005

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

12 luglio 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 luglio 2012

Ultimo verificato

1 luglio 2012

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • A6181077

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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