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A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly MORAb-003 in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer

Thank you

Trial Information

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly MORAb-003 in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse


Inclusion Criteria:



- A histologically or cytologically confirmed diagnosis of non-mucinous epithelial
ovarian cancer including primary peritoneal or fallopian tube malignancies

- Must have measurable disease by CT or MRI scan

- Must have relapsed radiologically with a randomization date within ≥6 and < 24 months
of completion of first-line platinum chemotherapy

- Have been treated with debulking surgery and first-line platinum and taxane based
chemotherapy.

- Prior bevacizumbab maintenance is allowed. The last dose of bevacizumab must have
been at least 30 days before study Day 1. No cytotoxic maintenance therapy (e.g.
taxane) or cancer vaccine therapy is allowed.

- Must be a candidate for carboplatin and taxane therapy

- Neurologic function: neuropathy (sensory and motor) ≤CTCAE Grade 1

Exclusion Criteria:

- Subjects who never responded to first-line platinum-based therapy or whose first
relapse occurs <6 months or >24 months from the last platinum therapy

- Subjects who have received other therapy to treat their ovarian cancer since relapse

- Known central nervous system (CNS) tumor involvement

- Evidence of other active invasive malignancy requiring treatment in the past 5 years

- Known allergic reaction to a prior monoclonal antibody therapy or have any documented
HAHA

- Previous treatment with MORAb-003 (farletuzumab)

- Clinical contraindications to use of a taxane

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival using by RECIST

Outcome Time Frame:

3 years

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

MORAb003-004

NCT ID:

NCT00849667

Start Date:

March 2009

Completion Date:

July 2013

Related Keywords:

  • Ovarian Cancer
  • ovarian cancer
  • relapsed ovarian cancer
  • Platinum-sensitive Ovarian Cancer
  • Ovarian Neoplasms

Name

Location

Arizona Cancer Center Tucson, Arizona  85724
Roswell Park Cancer Institute Buffalo, New York  14263
Abington Memorial Hospital Abington, Pennsylvania  19001
Medical University of South Carolina Charleston, South Carolina  29425-0721
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
Morristown Memorial Hospital Morristown, New Jersey  07962-1956
Stanford University Stanford, California  94305
Ingalls Memorial Hospital Harvey, Illinois  60426
University Hospitals of Cleveland Cleveland, Ohio  44106
Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224
Texas Oncology, P.A. Dallas, Texas  75246
University of California Davis Cancer Center Sacramento, California  95817
Carolinas Medical Center Charlotte, North Carolina  28232-2861
Scott and White Memorial Hospital Temple, Texas  76508
Cooper Cancer Institute Camden, New Jersey  08103
California Cancer Care, Inc. Greenbrae, California  94904-2007
MetroHealth Medical Center Cleveland, Ohio  44109
Central Baptist Hospital Lexington, Kentucky  40503
University of New Mexico Cancer Center Albuquerque, New Mexico  87131-5636
University of Colorado Denver, Colorado  80217
University of California San Diego La Jolla, California  92093
Vanderbilt University Medical Center Nashville, Tennessee  37232-2516
Miami Valley Hospital Dayton, Ohio  45409
Arena Oncology Associates Great Neck, New York  11021
Palm Beach Cancer Institute West Palm Beach, Florida  33401
Greater Baltimore Medical Center Baltimore, Maryland  21204
Presbyterian Hospital Charlotte, North Carolina  28233-3549
Washington Hospital Center Washington, District of Columbia  20010
Medical College of Georgia Augusta, Georgia  30912
Gynecologic Oncology Associates Newport Beach, California  92663
Hematology/Oncology Associates Port Saint Lucie, Florida  34952
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Oregon Health & Science University Portland, Oregon  97201
Duke University Medical Center Durham, North Carolina  27710
Cancer Care Associates Tulsa, Oklahoma  74136
Willamette Valley Cancer Center Eugene, Oregon  97401-8122
SUNY Upstate Medical University Syracuse, New York  13210
Northern Utah Associates Ogden, Utah  84403
Henry Ford Health System Detroit, Michigan  48202
Arizona Oncology Associates Tucson, Arizona  85712-2254
Lakeland Regional Cancer Center Lakeland, Florida  33805
University of Louisville Louisville, Kentucky  40202
The Center for Cancer and Hematologic Disease Cherry Hill, New Jersey  08003
Midwest Cancer Research Group Skokie, Illinois  60077
Providence St. Joseph Medical Center Burbank, California  91505
St. Vincent Gynecologic Oncology Indianapolis, Indiana  46260
Texas Oncology, PA Dallas, Texas  75246-2006
Utah Cancer Specialists Salt Lake City, Utah  84106
Mercy Medical Center Baltimore, Maryland  21202
Frederick Memorial Hospital Frederick, Maryland  21701
Florida Hospital Orlando, Florida  32803
Memorial Health University Medical Center Savannah, Georgia  31404
Kaiser Permanente - Moanalua Medical Center Honolulu, Hawaii  96819
Center for Cancer and Blood Disorders Bethesda, Maryland  20817
Chattanooga's Program in Women's Oncology Chattanooga, Tennessee  37403
Northern Virginia Pelvic Surgery Associates Annandale, Virginia  22003
Kaiser Permanente Northwest Portland, Oregon  97227
Arizona Hematology & Oncology Associates Phoenix, Arizona  85012
Saint Mary's Health Care Grand Rapids, Michigan  49503
Columbia University Medical Center New York, New York  10032
Kettering Medical Center Kettering, Ohio  45429
Harrison Bremerton Hematology and Oncology Bremerton, Washington  98310
Medical & Surgical Specialists, LLC Galesburg, Illinois  61401
Providence Everett Medical Center Everett, Washington  98201
Hematology & Oncology Specialists New Orleans, Louisiana  70115
Hematology Oncology P.C. Stamford, Connecticut  06902-3628
US Oncology Research Dallas, Texas  75204
Northwest Cancer Specialists, PC Vancouver, Washington  98684
Baptist Cancer Institute Jacksonville, Florida  32207
Palm Beach Institute of Hematology and Oncology Boynton Beach, Florida  33435
Magee-Womens Hospital of UPMC Pittsburgh, Pennsylvania  15213
Park Nicollet Institute St Louis Park, Minnesota  55416
Norton Healthcare Louisville, Kentucky  40202
Gainsville Hematology Oncology Associates Gainesville, Florida  32605
University of Texas Health Science Center at Houston Medical School Houston, Texas  77030
Aurora Health Care Elkhorn, Wisconsin  53121
Cancer Care Northwest-South Spokane, Washington  99202
South Texas Oncology and Hematology, PA San Antonio, Texas  78229
St. Luke's Hospital Bethlehem, Pennsylvania  18015
St. Francis Hospital & Health Centers Beech Grove, Indiana  46107
Signal Point Clinical Research Center, LLC Middletown, Ohio  45042
Oncology Specialties, PC Huntsville, Alabama  35805
Baylor Sammons Cancer Center Dallas, Texas  75246
John Hopkins University Baltimore, Maryland  21231
Loyola University Chicago Maywood, Illinois  60153
Central DuPage Hospital Winfield, Illinois  60190
Weinberg Cancer Institute at Franklin Square Baltimore, Maryland  21237
University Cancer Institute Boyton Beach, Florida  33426
St. Joseph's Hospital, Barrow Neurology Clinics Phoenix, Arizona  85013
University of California Los Angeles Medical Center Los Angeles, California  90095
Catholic Health Initiatives Colorado Springs, Colorado  80907
Denver Health and Hospital Authority Denver, Colorado  80204
Jupiter Medical center Physician's Group Jupiter, Florida  33458
Sarasota Memorial Healthcare System Sarasota, Florida  34239
Gulfcoast Oncology St. Petersburg, Florida  33705
Oncology-Hematology Associates of W. Broward P.A. Tamarac, Florida  33321
Kapi'olani Medical Center for Women and Children Honolulu, Hawaii  96826
Barbara Ann Kamanos Cancer Center Detroit, Michigan  48201
Saint Francis Memorial Health Center Grand Island, Nebraska  68803
Good Samaritan Hospital Cancer Center Kearney, Nebraska  68847
Hematology-Oncolgy Associates of NNJ-PA Denville, New Jersey  07834
John Theurer Cancer Center at Hackensack University MC Hackensack, New Jersey  07601
Piedmont Hematology & Oncology Winston-Salem, North Carolina  27103
Catholic Health Initiatives Cincinnati, Ohio  45220
Providence Oncology & Hematology Care Portland, Oregon  95213
Oncology Hematology Associates DuBois, Pennsylvania  15801
Gettysburg Cancer Center Gettysburg, Pennsylvania  17325
International Beneficence Clinical Research, L.L.C. Harlingen, Texas  78550
Peninsula Cancer Institute - Riverside Gynecology Oncology Newport News, Virginia  23601