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Patupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal Cancer

11. december 2020 opdateret af: Novartis Pharmaceuticals

A Randomized, Parallel Group, Open-label, Active Controlled, Multicenter Phase III Trial of Patupilone (EPO906) Versus Pegylated Liposomal Doxorubicin in Taxane/Platinum Refractory/Resistant Patients With Recurrent Epithelial Ovarian, Primary Fallopian or Primary Peritoneal Cancer

The objective of this study is to assess the safety and efficacy of patupilone compared to pegylated liposomal doxorubicin. Additionally, this study will assess the ability of patupilone to extend the survival time and potential beneficial effects in women who have nonresponsive or recurrent ovarian, primary fallopian, or primary peritoneal cancer.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

829

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Australien
      • Adelaide, Australien
        • Novartis Investigative Site
      • Herston, Australien
        • Novartis Investigative Site
      • Nedlands, WA, Australien
        • Novartis Investigative Site
      • South Brisbane, Australien
        • Novartis Investigative Site
      • St. Leonards, Australien
        • Novartis Investigative Site
      • Wodonga, Australien
        • Novartis Investigative Site
  • Canada
      • Calgary, Canada
        • Novartis Investigative Site
      • Montreal, Canada
        • Novartis Investigative Site
      • North York, Canada
        • Novartis Investigative Site
      • Quebec, Canada
        • Novartis Investigative Site
      • Sherbrooke, Canada
        • Novartis Investigative Site
      • Toronto, Canada, M5G 2M9
        • Novartis Investigative Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Agency
  • Danmark
      • Odense, Danmark
        • Novartis Investigative Site
      • Vejle, Danmark
        • Novartis Investigative Site
  • Det Forenede Kongerige
      • Glasgow, Det Forenede Kongerige
        • Novartis Investigative Site
      • London, Det Forenede Kongerige
        • Novartis Investigative Site
      • Wirral, Det Forenede Kongerige
        • Novartis Investigative Site
      • Wolverhampton, Det Forenede Kongerige
        • Novartis Investigative Site
  • Finland
      • Helsinki, Finland
        • Novartis Investigative Site
      • Kuopio, Finland
        • Novartis Investigative Site
      • Tampere, Finland
        • Novartis Investigative Site
  • Forenede Stater
    • Alaska
      • Anchorage, Alaska, Forenede Stater, 99508
        • Alaska Cancer Research & Education Center
    • Arizona
      • Flagstaff, Arizona, Forenede Stater, 86001
        • Northern Arizona Hematology & Oncology Associates
      • Scottsdale, Arizona, Forenede Stater, 85259
        • Mayo Center for Women's Health
      • Sedona, Arizona, Forenede Stater, 86336
        • Northern Arizona Hematology & Oncology Associates
    • Arkansas
      • Hot Springs, Arkansas, Forenede Stater, 71913
        • Genesis Cancer Center
      • Little Rock, Arkansas, Forenede Stater, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Gilroy, California, Forenede Stater, 95020
        • Yanagihara, Ronald H.
      • Greenbrae, California, Forenede Stater, 94904
        • California Cancer Care, Inc.
      • La Jolla, California, Forenede Stater, 92093-0987
        • University of California - San Diego/ Moores Cancer Center
      • Los Angeles, California, Forenede Stater, 90033
        • LAC & USC Women's & Children's Hospital
      • Newport Beach, California, Forenede Stater, 92663
        • Gynecologic Oncology Associates
      • Sacramento, California, Forenede Stater, 95817
        • UC Davis Cancer Center
      • San Francisco, California, Forenede Stater, 94115
        • California Pacific Medical Center Research Institute
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80045
        • Anschutz Cancer Pavilion
      • Aurora, Colorado, Forenede Stater, 90045
        • Anschutz Cancer Pavilion - Clinical Investigations Core
      • Denver, Colorado, Forenede Stater, 80262
        • University of Colorado Health Sciences Center
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06520
        • Yale University School of Medicine
    • Delaware
      • Newark, Delaware, Forenede Stater, 19713
        • Christiana Gynecologic Oncology, LLC
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater, 20010-2931
        • Washington Hospital Center/Medstar Research Institute
    • Florida
      • Fort Myers, Florida, Forenede Stater, 33901
        • Florida Gynecologic Oncology
      • Miami, Florida, Forenede Stater, 33136
        • University of Miami
      • Miami, Florida, Forenede Stater, 33176
        • Advanced Medical Specialties
      • Miami, Florida, Forenede Stater, 33133
        • Miami Cancer Center at Mercy Hospital
      • Miami, Florida, Forenede Stater, 33133
        • Miami Cancer Center at University Hospital
      • Miami, Florida, Forenede Stater, 33143
        • Mt. Sinai Medical Center
      • Ocala, Florida, Forenede Stater, 34471
        • Ocala Oncology Center
      • Orlando, Florida, Forenede Stater, 32806
        • MD Anderson Cancer Center of Orlando
      • Tamarac, Florida, Forenede Stater, 33321
        • Oncology & Hematology Associates of West Broward
      • Tampa, Florida, Forenede Stater, 33607
        • Xelero Medical Research/Giselle Ghurani
    • Georgia
      • Augusta, Georgia, Forenede Stater, 30912
        • Medical College of Georgia
      • Savannah, Georgia, Forenede Stater, 31404
        • Memorial Health University Medical Center
    • Hawaii
      • Honolulu, Hawaii, Forenede Stater, 96826
        • Kapiolani Medical Center for Women and Children/Univ. of HI
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60612
        • Rush University Medical Center
      • Chicago, Illinois, Forenede Stater, 60611
        • Northwest Memorial Hospital
      • Decatur, Illinois, Forenede Stater, 62526
        • Cancer Institute of Central Illinois/Decatur Memorial Hospital
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 00144
        • Indiana University Obstetrics
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana University Cancer Center/Indiana UNiversity Melvin & Bren Simon Cancer Center
      • Indianapolis, Indiana, Forenede Stater, 46267
        • Gynecologic Oncology of Indiana/St. Francis Cancer Research Foundation
      • South Bend, Indiana, Forenede Stater, 46617
        • Northern Indiana Cancer Research Consortium
    • Kentucky
      • Louisville, Kentucky, Forenede Stater, 40202
        • Louisville Oncology
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21237
        • Franklin Square Hospital Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02118
        • Boston University Medical Center Hospital
    • Michigan
      • Southfield, Michigan, Forenede Stater, 48075
        • Providence Cancer Center
    • Minnesota
      • Burnsville, Minnesota, Forenede Stater, 55337
        • Minnesota Oncology/Hematology, PA
      • Duluth, Minnesota, Forenede Stater, 55805
        • St. Luke's Hospital
      • Edina, Minnesota, Forenede Stater, 55435
        • Minnesota Oncology/Hematology, PA
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • University of Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55404
        • Minnesota Oncology/Hematology Associates of Central Illinois
      • Saint Louis Park, Minnesota, Forenede Stater, 55416
        • Metro-MN CCOP
      • Saint Paul, Minnesota, Forenede Stater, 55102-2389
        • Minnesota Oncology Hematology
    • Mississippi
      • Corinth, Mississippi, Forenede Stater, 38834
        • The West Clinic
      • Southaven, Mississippi, Forenede Stater, 38671
        • The West Clinic
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
        • St. Luke's Hospital of Kansas City/St. Luke's Cancer Institute
      • Saint Louis, Missouri, Forenede Stater, 63110
        • Washington University School of Medicine
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68510
        • Southeast Nebraska Oncology/Southeast Nebraska Cancer Center
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89109
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Forenede Stater, 89109
        • Women's Cancer Center of Nevada
    • New Hampshire
      • Lebanon, New Hampshire, Forenede Stater, 03756
        • Dartmouth-Hitchcock Medical Center
    • New Jersey
      • Morristown, New Jersey, Forenede Stater, 07962
        • Hematology and Oncology Associates of Northern New Jersey
      • New Brunswick, New Jersey, Forenede Stater, 07090
        • University of Medicine and Dentistry of New Jersey/The Cancer Institute of Neew Jersey
    • New York
      • Albany, New York, Forenede Stater, 12208
        • New York Oncology Hematology, P.C.
      • Babylon, New York, Forenede Stater, 11702
        • Schwartz Gynecologic Oncology, PLLC
      • New York, New York, Forenede Stater, 10016
        • NYU Cancer Institute
      • New York, New York, Forenede Stater, 10016
        • Bellview Hospital
      • New York, New York, Forenede Stater, 10016
        • New York University School of Medicine/NYU Cancer Institute
      • Staten Island, New York, Forenede Stater, 10310
        • St. Vincent Catholic Medical Center of New York
    • North Carolina
      • Greenville, North Carolina, Forenede Stater, 27834
        • Brody School of Medicine
      • Wilmington, North Carolina, Forenede Stater, 28401
        • New Hanover Regional Medical Center/Zimmer Cancer Center
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210-1228
        • Ohio State University Medical Center
      • Columbus, Ohio, Forenede Stater, 43214
        • Camelot Women's Cancer
      • Columbus, Ohio, Forenede Stater, 43214
        • The Arthur G. James Cancer Hospital
    • Oklahoma
      • Tulsa, Oklahoma, Forenede Stater, 74136
        • Cancer Care Associates
    • Oregon
      • Eugene, Oregon, Forenede Stater, 97401-8122
        • Oncology Associates of Oregon, PC/Willaimette Valley Cancer Center
      • Portland, Oregon, Forenede Stater, 97227
        • Northwest Cancer Specialists, P.C.
      • Springfield, Oregon, Forenede Stater, 97477
        • Willamette Valley Cancer Center
    • Pennsylvania
      • Kingston, Pennsylvania, Forenede Stater, 18704
        • Medical Oncology Associates of Wyoming Valley, PC
      • Pittsburgh, Pennsylvania, Forenede Stater, 15213
        • Magee - Women's Hospital
    • South Carolina
      • Greenville, South Carolina, Forenede Stater, 29601
        • GYN Oncology Research/Gynecologic Oncology Research & Development, LLC
    • Tennessee
      • Chattanooga, Tennessee, Forenede Stater, 37403
        • Chattanooga GYN Oncology
      • Knoxville, Tennessee, Forenede Stater, 37920
        • Hall and Martin MDs, PC
      • Memphis, Tennessee, Forenede Stater, 38120
        • West Clinic
      • Memphis, Tennessee, Forenede Stater, 38104
        • The West Clinic
    • Texas
      • Austin, Texas, Forenede Stater, 78731
        • Texas Oncology, P.A.
      • Austin, Texas, Forenede Stater, 78745
        • Texas Oncology
      • Bedford, Texas, Forenede Stater, 76022
        • Texas Oncology, P.A.
      • Dallas, Texas, Forenede Stater, 75246
        • Texas Oncology, P.A.
      • Dallas, Texas, Forenede Stater, 75246
        • Sammons Cancer Center
      • Dallas, Texas, Forenede Stater, 75231
        • Texas Oncology, P.A.
      • Fort Worth, Texas, Forenede Stater, 76104
        • Texas Oncology, P.A.
      • Houston, Texas, Forenede Stater, 77024
        • Oncology Consultants P.A.
      • San Antonio, Texas, Forenede Stater, 78229
        • Cancer Care Center of South Texas
      • Waco, Texas, Forenede Stater, 76712
        • Waco Cancer Care & Research Center
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84106
        • Utah Cancer Specialists
    • Vermont
      • Burlington, Vermont, Forenede Stater, 05401
        • Fletcher Allen Health Care
    • Virginia
      • Abingdon, Virginia, Forenede Stater, 24211
        • Cancer Outreach Associates
      • Annandale, Virginia, Forenede Stater, 22003
        • Northern Virginia Pelvic Surgery Associates
      • Newport News, Virginia, Forenede Stater, 23606
        • Virginia Oncology Associates
      • Norfolk, Virginia, Forenede Stater, 23502
        • Virginia Oncology Associates
      • Richmond, Virginia, Forenede Stater, 23298
        • Virginia Commonwealth University/VCU Massey Cancer Center
    • Washington
      • Spokane, Washington, Forenede Stater, 99202
        • Gersh, Robert
      • Vancouver, Washington, Forenede Stater, 98664
        • Northwest Cancer Specialists
      • Vancouver, Washington, Forenede Stater, 98664
        • Northwest Cancer Specialists, P.C.
      • Yakima, Washington, Forenede Stater, 98902
        • Yakima Valley Memorial Hospital
    • Wisconsin
      • West Allis, Wisconsin, Forenede Stater, 53227
        • Aurora Medical Gyn Group
  • Frankrig
      • Amboise, Frankrig
        • Novartis Investigative Site
      • Bordeaux, Frankrig
        • Novartis Investigative Site
      • Caen Cedex, Frankrig
        • Novartis Investigative Site
      • Herblain Cedec, Frankrig
        • Novartis Investigative Site
      • Villejuif Cedex, Frankrig
        • Novartis Investigative Site
  • Grækenland
      • Athens, Grækenland
        • Novartis Investigative Site
  • Italien
      • Bologna, Italien
        • Novartis Investigative Site
      • Milano, Italien
        • Novartis Investigative Site
      • Modena, Italien
        • Novartis Investigative Site
      • Monza, Italien
        • Novartis Investigative Site
      • Padova, Italien
        • Novartis Investigative Site
      • Roma, Italien
        • Novartis Investigative Site
      • Torino, Italien
        • Novartis Investigative Site
  • Polen
      • Krakow, Polen
        • Novartis Investigative Site
  • Spanien
      • Barcelona, Spanien
        • Novartis Investigative Site
      • Madrid, Spanien
        • Novartis Investigative Site
  • Sydafrika
      • Cape Town, Sydafrika
        • Novartis Investigative Site
      • Johannesburg, Gauteng, Sydafrika
        • Novartis Investigative Site
      • Klerksdorp, Sydafrika
        • Novartis Investigative Site
      • Port Elizabeth, Sydafrika
        • Novartis Investigative Site
      • Pretoria, Gauteng, Sydafrika
        • Novartis Investigative Site
      • Pretoria, Guateng, Sydafrika
        • Novartis Investigative Site
      • Sandton, Gauteng, Sydafrika
        • Novartis Investigative 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

Kvinde

Beskrivelse

Inclusion Criteria:

  • 18 years of age or older
  • Confirmed diagnosis of ovarian, fallopian or peritoneal cancer
  • No more than three chemotherapy regimens
  • Most recent regimen must have been platinum based

Exclusion Criteria:

  • Have an unresolved bowel obstruction
  • Have had previous chemotherapy within 3 weeks
  • Recovering from any surgery for any cause

Other protocol-defined inclusion/exclusion criteria will apply.

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
Eksperimentel: Patupilone
Medicin: EPO906 (Patupilone)
Andre navne:
  • Patupilone
Aktiv komparator: doxorubicin
Medicin: doxorubicin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer
Tidsramme: every 8 weeks
every 8 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
To determine the duration of overall response in patients with complete response (CR) or partial response (PR) or stable disease (SD)
Tidsramme: End of study
End of study
To determine the progression-free survival (PFS) of patients treated with patupilone
Tidsramme: end of study
end of study
To determine the time to disease progression (TTP) of patients treated with patupilone
Tidsramme: end of study
end of study
To determine overall best tumor response (CR, PR, SD, PD and Unknown)
Tidsramme: end of study
end of study
To investigate the safety and tolerability of patupilone
Tidsramme: end of study
end of study
To evaluate the pharmacokinetics (PK) of patupilone from all patients
Tidsramme: end of study
end of study
To explore relationships between Cmin (pre-dose patupilone blood concentration) and efficacy/adverse events
Tidsramme: end of study
end of study

Samarbejdspartnere og efterforskere

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

Sponsor

Novartis Pharmaceuticals

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

Hjælpsomme links

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. november 2005

Primær færdiggørelse (Faktiske)

1. februar 2010

Datoer for studieregistrering

Først indsendt

6. december 2005

Først indsendt, der opfyldte QC-kriterier

6. december 2005

Først opslået (Skøn)

7. december 2005

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. december 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. december 2020

Sidst verificeret

1. maj 2012

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CEPO906A2303

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 .

Kliniske forsøg med Peritoneale neoplasmer

Kliniske forsøg med doxorubicin

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Bosnia & Herzegovina

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
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