An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer (FAR-122)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00738699 |
Recruitment Status
:
Terminated
(study did not meet pre-specified criteria for continuation following interim futility analysis)
First Posted
: August 20, 2008
Results First Posted
: March 30, 2017
Last Update Posted
: March 30, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Ovarian Cancer | Drug: MORAb-003 (farletuzumab) Drug: 0.9% Saline Drug: Paclitaxel | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 415 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | January 2012 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
MORAb-003 (Farletuzumab) Plus Paclitaxel
|
Drug: MORAb-003 (farletuzumab)
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.
Drug: Paclitaxel
Other Name: Paclitaxel (80 mg/m^2) was administered by IV infusion over 1 hour following administration of FAR.
|
Placebo Comparator: 2
Placebo Plus Paclitaxel
|
Drug: 0.9% Saline
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.
Drug: Paclitaxel
Other Name: Paclitaxel (80 mg/m^2) was administered by IV infusion over 1 hour following administration of FAR.
|
- Progression-Free Survival (PFS) [ Time Frame: 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 ]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).
- Overall Survival (OS) [ Time Frame: Date of Randomization to date of death, assessed up to study termination (28 Nov 2011), or up to approximately 2 years 10 months ]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.
- Best Overall Response [ Time Frame: 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 ]BOR was defined as the percentage of participants having either a confirmed complete response (CR) or confirmed partial response (PR) using modified RECIST criteria by independent radiologist review. RECIST criteria was adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Tumor assessments performed up to the initiation of further antitumor treatment were considered. Target lesions selected for response assessment were measured using computed tomography (CT) or magnetic resonance imaging (MRI) scans then graded according to the modified RECIST criteria, adjusted based on current medical practices and on possible differences between ovarian cancer and other solid tumors. Participants were assigned to one of the categories of change in disease state; CR, PR, progressive disease (PD), stable disease ( S)D, or not evaluable (NE).
- Time to Tumor Response (TTR) [ Time Frame: 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 ]TTR was derived for those participants with objective evidence of CR or PR, and was defined as the time (in months) from the date of randomization to the first documentation of object tumor response (TR). Analysis was based on the Kaplan-Meier estimated percentage of responders. This statistical analysis method measures the effect of study drug on tumor response over a period of time.
- Progression Free Survival Based on Gynecologic Cancer InterGroup (GCIG) [ Time Frame: Length of study ]Due to termination of the study, data were not collected and the outcome measure for PFS based on GCIG was not analyzed.
- Serologic Response Rate [ Time Frame: Length of study ]Due to termination of the study, data were not collected and the outcome measure for Serologic Response Rate was not analyzed.

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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:
- 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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00738699

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 |
Responsible Party: | Morphotek |
ClinicalTrials.gov Identifier: | NCT00738699 History of Changes |
Other Study ID Numbers: |
MORAb003-003PR |
First Posted: | August 20, 2008 Key Record Dates |
Results First Posted: | March 30, 2017 |
Last Update Posted: | March 30, 2017 |
Last Verified: | February 2017 |
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 Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |