An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer (FAR-122)

This study has been terminated.
(study did not meet pre-specified criteria for continuation following interim futility analysis)
Sponsor:
Information provided by (Responsible Party):
Morphotek
ClinicalTrials.gov Identifier:
NCT00738699
First received: August 18, 2008
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

The study is being conducted to find out if paclitaxel works better when given together with an experimental drug called MORAb-003(farletuzumab) or alone in patients with platinum-resistant or refractory relapsed ovarian cancer


Condition Intervention Phase
Ovarian Cancer
Drug: MORAb-003 (farletuzumab)
Drug: 0.9% Saline
Phase 3

Study Type: 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
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Morphotek:

Primary Outcome Measures:
  • Progression-free survival (PFS) as determined by RECIST [ Time Frame: Length of Study ] [ Designated as safety issue: No ]
    PFS as determined by RECIST

  • Overall Survival [ Time Frame: Length of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival based on Gynecologic Cancer InterGroup(GCIG) [ Time Frame: Length of study ] [ Designated as safety issue: No ]
    PFS as assessed byt CGIG criteria

  • Overall Response Rate [ Time Frame: Length of study ] [ Designated as safety issue: No ]
  • Serologic response rate [ Time Frame: Length of study ] [ Designated as safety issue: No ]
    Serologic response rate assessed by modified Rustin Criteria

  • Safety and tolerability [ Time Frame: Length of Study ] [ Designated as safety issue: Yes ]
    Assessed by safety measurements such as review of Adverse events, Vital signs, Physical exams, Electrocardiograms, Clinical labrotory tests, Karnofsky's performance status.


Enrollment: 417
Study Start Date: September 2008
Study Completion Date: October 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Paclitaxel with MORAb-003(farletuzumab)
Drug: MORAb-003 (farletuzumab)
2.5mg/kg IV day 1 weeks 1-12 (cycle 1); day 1 weeks 1-3 with week 4 as rest week for subsequent cycles
Placebo Comparator: 2
Paclitaxel with Placebo
Drug: 0.9% Saline
2.5mg/kg IV day 1 weeks 1-12 (cycle 1); day 1 weeks 1-3 with week 4 as rest week for subsequent cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00738699

  Hide Study Locations
Locations
United States, Alabama
Southern Cancer Center
Mobile, Alabama, United States, 36608
United States, Arizona
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
United States, California
California Cancer Care, Inc.
Greenbrae, California, United States, 94904
Moores UC San Diego Cancer Center
La Jolla, California, United States, 92093
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Monterey Bay Oncology
Monterey, California, United States, 93940
United States, Florida
Jupiter Medical Center
Jupiter, Florida, United States, 33458
Innovative Medical Research of South Florida, Inc.
Miami, Florida, United States, 33179
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
Sarasota Memorial Hospital
Sarasota, Florida, United States, 34239
United States, Georgia
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
United States, Illinois
Central DuPage Hospital
Winfield, Illinois, United States, 60190
United States, Indiana
St. Vincent Gynecologic Oncology
Indianapolis, Indiana, United States, 46260
United States, Louisiana
Hematology and Oncology Specialists, LLC
Metairie, Louisiana, United States, 70006
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231
Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, United States, 21237
United States, Michigan
Henry Ford Health System
Detroit, Michigan, United States, 48202
United States, New Jersey
Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
United States, New York
Schwartz Gynecologic Oncology, PLLC
Brightwaters, New York, United States, 11718
Arena Oncology Associates, PC
Lake Success, New York, United States, 11042
St. Luke's Roosevelt Hospital Center
New York, New York, United States, 10019
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
Piedmont Hematology Oncology Associates, PA
Winston Salem, North Carolina, United States, 27103
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Signal Point Clinical Research Center
Middletown, Ohio, United States, 45042
United States, Oklahoma
Cancer Care Associates
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Magee-Women's Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
International Beneficence Clinical Research, LLC
Harlingen, Texas, United States, 78550
South Texas Oncology & Hematology PA
San Antonio, Texas, United States, 78229
Scott & White Memorial Hospital and Clinic
Temple, Texas, United States, 76508
United States, Utah
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
United States, Virginia
Northern Virginia Pelvic Surgery Associates
Annandale, Virginia, United States, 22003
Australia, New South Wales
Prince of Wales Hospital
Randwick, New South Wales, Australia, 2031
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia, 4029
Australia, South Australia
The Burnside War Memorial Hospital, Inc.
Toorak Gardens, South Australia, Australia, 5064
Australia, Victoria
Monash Medical Centre
East Bentleigh, Victoria, Australia, 3165
Mercy Hospital for Women
Heidelburg, Victoria, Australia, 3084
The Royal Women's Hospital
Parkville, Victoria, Australia, 3052
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
St. John of God Hospital
Subiaco, Western Australia, Australia, 6008
Belgium
AZ Greninge Hospital
Kortrijk, Belgium
University Hospitals Leuven
Leuven, Belgium
CHU de Liege
Liege, Belgium
Canada, Alberta
Tom Baker Cancer Centre
Calgary, Alberta, Canada, T2N 4N2
Canada, British Columbia
BC Cancer Agency
Kelowna, British Columbia, Canada, V1Y5L3
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 5C2
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Netherlands
UMCG
Groningen, Netherlands, 9700 RB
University Hospital Maastricht
Maastricht, Netherlands, 6229 HX
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Spain
Hospital Universitario Son Dureta
Palma de Mallorca, Baleares, Spain, 07014
Hospital de Son Llatzer
Palma de Mallorca, Baleares, Spain, 07198
Hospital de Mataro
Mataro, Barcelona, Spain, 08304
Corporacio Sanitaria Parc Taulis
Sabadell, Barcelona, Spain, 08208
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain, 08227
Fundacion Hospital Alcorcon
Alcorcon, Madrid, Spain, 28922
Hospital Clinic I Provincial
Barcelona, Spain, 08036
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Sponsors and Collaborators
Morphotek
  More Information

No publications provided

Responsible Party: Morphotek
ClinicalTrials.gov Identifier: NCT00738699     History of Changes
Other Study ID Numbers: MORAb003-003PR
Study First Received: August 18, 2008
Last Updated: November 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Morphotek:
ovarian cancer
relapsed ovarian cancer
refractory ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014