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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
N/A
Not Enrolling
Female
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
chemotherapy;

- 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:

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 (PFS) as determined by RECIST

Outcome Description:

PFS as determined by RECIST

Outcome Time Frame:

Length of Study

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

MORAb003-003PR

NCT ID:

NCT00738699

Start Date:

September 2008

Completion Date:

April 2012

Related Keywords:

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

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800
Abington Memorial HospitalAbington, Pennsylvania  19001
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Morristown Memorial HospitalMorristown, New Jersey  07962-1956
St. Joseph's Hospital and Medical CenterPhoenix, Arizona  85001-2071
Sarasota Memorial HospitalSarasota, Florida  34239
Florida Hospital Cancer InstituteOrlando, Florida  32804
California Cancer Care, Inc.Greenbrae, California  94904-2007
Cancer Care AssociatesTulsa, Oklahoma  74136
Henry Ford Health SystemDetroit, Michigan  48202
Innovative Medical Research of South Florida, Inc.Miami, Florida  33138
Cleveland ClinicCleveland, Ohio  44195
Monterey Bay OncologyMonterey, California  93940
Hematology and Oncology Specialists, LLCNew Orleans, Louisiana  70115
St. Vincent Gynecologic OncologyIndianapolis, Indiana  46260
Utah Cancer SpecialistsSalt Lake City, Utah  84106
Memorial Health University Medical CenterSavannah, Georgia  31404
Northern Virginia Pelvic Surgery AssociatesAnnandale, Virginia  22003
Jupiter Medical CenterJupiter, Florida  33458
Johns Hopkins HospitalBaltimore, Maryland  21287
Schwartz Gynecologic Oncology, PLLCBabylon, New York  11702
St. Luke's Roosevelt Hospital CenterNew York, New York  10019
Southern Cancer CenterMobile, Alabama  36608
Arena Oncology Associates, PCGreat Neck, New York  11021
Signal Point Clinical Research CenterMiddletown, Ohio  45042
Moores UC San Diego Cancer CenterLa Jolla, California  92093
Central DuPage HospitalWinfield, Illinois  60190
Weinberg Cancer Institute at Franklin SquareBaltimore, Maryland  21237
Piedmont Hematology Oncology Associates, PAWinston Salem, North Carolina  27103
Magee-Women's Hospital of UPMCPittsburgh, Pennsylvania  15213
International Beneficence Clinical Research, LLCHarlingen, Texas  78550
South Texas Oncology & Hematology PASan Antonio, Texas  78229
Scott & White Memorial Hospital and ClinicTemple, Texas  76508