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A Randomized, Double Blind, Placebo-Controlled Study of the Efficacy and Safety oF MORAb-003(Farletuzumab)in Combination With Paclitaxel Therapy in Subjects With Platinum-Resistant or Refractory Relapsed Ovarian Cancer

Phase 3
18 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

A Randomized, Double Blind, Placebo-Controlled Study of the Efficacy and Safety oF MORAb-003(Farletuzumab)in Combination With Paclitaxel Therapy in Subjects With Platinum-Resistant or Refractory Relapsed Ovarian Cancer

Inclusion Criteria:

- Diagnosis of non-mucinous epithelial ovarian cancer, including primary peritoneal and
fallopian tube malignancies, measurable by CT or MRI scan assessed within 4 weeks
prior to study entry

- Must have evidence of relapse by CA-125 (2xUpper Limit of Normal) or radiographically
within 6 months of most recent platinum-containing chemotherapy. At least one of the
lines of chemotherapy must have included a taxane.

- Must have been treated with debulking surgery and at least one line platinum-based

- Subjects may have received up to four additional lines of chemotherapy after they
developed platinum-resistance.

- Subjects must be candidate for repeat paclitaxel treatment

Exclusion Criteria:

- Clinical contraindications to use of paclitaxel, which include:

1. persistent Grade 2 or greater peripheral neuropathy

2. prior hypersensitivity reaction that persisted despite rechallenge with or
without desensitization or resulted in bronchospasm or hemodynamic instability
or was at least Grade 2 and resulted in medication discontinuation

- Current diagnosis of epithelial ovarian tumor of low malignant potential (borderline
carcinomas). Note: EOC with prior diagnosis of a low malignant potential tumor that
has been surgically resected is acceptable provided the subject did

- Prior radiation therapy is excluded with the exception that it is allowable only if
measurable disease for ovarian cancer is completely outside the radiation portal

- Known allergic reaction to a prior monoclonal antibody therapy or have any documented
human anti-human antibody (HAHA).

- Previous treatment with MORAb-003 (farletuzumab).

Type of Study:


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 (PFS) as determined by RECIST

Outcome Description:

PFS as determined by RECIST

Outcome Time Frame:

Length of Study

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2008

Completion Date:

April 2012

Related Keywords:

  • Ovarian Cancer
  • ovarian cancer
  • relapsed ovarian cancer
  • refractory ovarian cancer
  • Ovarian Neoplasms



Memorial Sloan-Kettering Cancer Center New York, New York  10021
USC/Norris Comprehensive Cancer Center Los Angeles, California  90033-0800
Abington Memorial Hospital Abington, Pennsylvania  19001
Medical University of South Carolina Charleston, South Carolina  29425-0721
Morristown Memorial Hospital Morristown, New Jersey  07962-1956
St. Joseph's Hospital and Medical Center Phoenix, Arizona  85001-2071
Sarasota Memorial Hospital Sarasota, Florida  34239
Florida Hospital Cancer Institute Orlando, Florida  32804
California Cancer Care, Inc. Greenbrae, California  94904-2007
Cancer Care Associates Tulsa, Oklahoma  74136
Henry Ford Health System Detroit, Michigan  48202
Innovative Medical Research of South Florida, Inc. Miami, Florida  33138
Cleveland Clinic Cleveland, Ohio  44195
Monterey Bay Oncology Monterey, California  93940
Hematology and Oncology Specialists, LLC New Orleans, Louisiana  70115
St. Vincent Gynecologic Oncology Indianapolis, Indiana  46260
Utah Cancer Specialists Salt Lake City, Utah  84106
Memorial Health University Medical Center Savannah, Georgia  31404
Northern Virginia Pelvic Surgery Associates Annandale, Virginia  22003
Jupiter Medical Center Jupiter, Florida  33458
Johns Hopkins Hospital Baltimore, Maryland  21287
Schwartz Gynecologic Oncology, PLLC Babylon, New York  11702
St. Luke's Roosevelt Hospital Center New York, New York  10019
Southern Cancer Center Mobile, Alabama  36608
Arena Oncology Associates, PC Great Neck, New York  11021
Signal Point Clinical Research Center Middletown, Ohio  45042
Moores UC San Diego Cancer Center La Jolla, California  92093
Central DuPage Hospital Winfield, Illinois  60190
Weinberg Cancer Institute at Franklin Square Baltimore, Maryland  21237
Piedmont Hematology Oncology Associates, PA Winston Salem, North Carolina  27103
Magee-Women's Hospital of UPMC Pittsburgh, Pennsylvania  15213
International Beneficence Clinical Research, LLC Harlingen, Texas  78550
South Texas Oncology & Hematology PA San Antonio, Texas  78229
Scott & White Memorial Hospital and Clinic Temple, Texas  76508