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

December 11, 2020 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

829

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patupilone
Drug: EPO906 (Patupilone)
Other Names:
  • Patupilone
Active Comparator: doxorubicin
Drug: doxorubicin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer
Time Frame: every 8 weeks
every 8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

December 6, 2005

First Submitted That Met QC Criteria

December 6, 2005

First Posted (Estimate)

December 7, 2005

Study Record Updates

Last Update Posted (Actual)

December 17, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEPO906A2303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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