Study Stopped
study did not meet pre-specified criteria for continuation following interim futility analysis
An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer
FAR-122
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
1 other identifier
interventional
415
6 countries
61
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 ovarian-cancer
Started Sep 2008
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2008
CompletedFirst Posted
Study publicly available on registry
August 20, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
March 30, 2017
CompletedMarch 30, 2017
February 1, 2017
3.2 years
August 18, 2008
December 13, 2016
February 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Progression-Free Survival (PFS)
PFS was defined as the time (in months) from the date of randomization to the date of the first observation of progression as determined by modified Response Evaluation Criteria in Solid Tumors (RECIST), or death regardless of cause. If progression or death was not observed, the PFS time was censored at the date of the last tumor assessment without evidence of progression before the date of initiation of further antitumor treatment, or the cutoff date (whichever was earlier).
Date of Randomization to date of disease progression or death (whichever came first), assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months
Overall Survival (OS)
OS was defined as the time (in months) from the date of randomization to the date of death, whatever the cause. If death was not observed for a participant, the survival time was censored on the last date the participant was known to be alive or the cutoff date, whichever was earlier.
Date of Randomization to date of death, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months
Secondary Outcomes (2)
Best Overall Response
Date of first study drug to disease progression/recurrence, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months
Time to Tumor Response (TTR)
Date of Randomization to the first documentation of objective TR, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months
Other Outcomes (2)
Progression Free Survival Based on Gynecologic Cancer InterGroup (GCIG)
Length of study
Serologic Response Rate
Length of study
Study Arms (2)
1
ACTIVE COMPARATORMORAb-003 (Farletuzumab) Plus Paclitaxel
2
PLACEBO COMPARATORPlacebo Plus Paclitaxel
Interventions
Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles.
Placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Clinical contraindications to use of paclitaxel, which include:
- persistent Grade 2 or greater peripheral neuropathy
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Morphoteklead
Study Sites (61)
Southern Cancer Center
Mobile, Alabama, 36608, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
California Cancer Care, Inc.
Greenbrae, California, 94904, United States
Moores UC San Diego Cancer Center
La Jolla, California, 92093, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Monterey Bay Oncology
Monterey, California, 93940, United States
Jupiter Medical Center
Jupiter, Florida, 33458, United States
Innovative Medical Research of South Florida, Inc.
Miami, Florida, 33179, United States
Florida Hospital Cancer Institute
Orlando, Florida, 32804, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
Central DuPage Hospital
Winfield, Illinois, 60190, United States
St. Vincent Gynecologic Oncology
Indianapolis, Indiana, 46260, United States
Hematology and Oncology Specialists, LLC
Metairie, Louisiana, 70006, United States
Johns Hopkins Hospital
Baltimore, Maryland, 21231, United States
Weinberg Cancer Institute at Franklin Square
Baltimore, Maryland, 21237, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Morristown Memorial Hospital
Morristown, New Jersey, 07962, United States
Schwartz Gynecologic Oncology, PLLC
Brightwaters, New York, 11718, United States
Arena Oncology Associates, PC
Lake Success, New York, 11042, United States
St. Luke's Roosevelt Hospital Center
New York, New York, 10019, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065, United States
Piedmont Hematology Oncology Associates, PA
Winston-Salem, North Carolina, 27103, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Signal Point Clinical Research Center
Middletown, Ohio, 45042, United States
Cancer Care Associates
Tulsa, Oklahoma, 74136, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Magee-Women's Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
International Beneficence Clinical Research, LLC
Harlingen, Texas, 78550, United States
South Texas Oncology & Hematology PA
San Antonio, Texas, 78229, United States
Scott & White Memorial Hospital and Clinic
Temple, Texas, 76508, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Northern Virginia Pelvic Surgery Associates
Annandale, Virginia, 22003, United States
Prince of Wales Hospital
Randwick, New South Wales, 2031, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Royal Brisbane & Women's Hospital
Herston, Queensland, 4029, Australia
The Burnside War Memorial Hospital, Inc.
Toorak Gardens, South Australia, 5064, Australia
Monash Medical Centre
East Bentleigh, Victoria, 3165, Australia
Mercy Hospital for Women
Heidelburg, Victoria, 3084, Australia
The Royal Women's Hospital
Parkville, Victoria, 3052, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009, Australia
St. John of God Hospital
Subiaco, Western Australia, 6008, Australia
AZ Greninge Hospital
Kortrijk, Belgium
University Hospitals Leuven
Leuven, Belgium
CHU de Liege
Liège, Belgium
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
BC Cancer Agency
Kelowna, British Columbia, V1Y5L3, Canada
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
UMCG
Groningen, 9700 RB, Netherlands
University Hospital Maastricht
Maastricht, 6229 HX, Netherlands
UMC Utrecht
Utrecht, 3584 CX, Netherlands
Hospital Universitario Son Dureta
Palma de Mallorca, Balearic Islands, 07014, Spain
Hospital de Son Llatzer
Palma de Mallorca, Balearic Islands, 07198, Spain
Hospital Clinic I Provincial
Barcelona, Barcelona, 08036, Spain
Hospital de Mataro
Mataró, Barcelona, 08304, Spain
Corporacio Sanitaria Parc Taulis
Sabadell, Barcelona, 08208, Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, 08227, Spain
Fundacion Hospital Alcorcon
Alcorcón, Madrid, 28922, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was prematurely terminated by the sponsor following results of the preplanned futility analysis showing the study was unlikely to meet its statistically-defined coprimary endpoints.
Results Point of Contact
- Title
- Eisai Medical Services
- Organization
- Eisai Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2008
First Posted
August 20, 2008
Study Start
September 1, 2008
Primary Completion
December 1, 2011
Study Completion
January 1, 2012
Last Updated
March 30, 2017
Results First Posted
March 30, 2017
Record last verified: 2017-02