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

Study Description

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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

Condition or disease	Intervention/treatment	Phase
Ovarian Cancer	Drug: MORAb-003 (farletuzumab); Drug: 0.9% Saline; Drug: Paclitaxel	Phase 2

Detailed Description:

Safety was assessed by the monitoring and recording of all adverse events (AEs), including drug hypersensitivity adverse events (DHAE), and serious adverse events (SAEs); clinical laboratory test (serum chemistry, hematology, urinalysis); tolerability (discontinuations, treatment delays, dose reductions); physical examinations (including vital signs assessment); 12-lead electrocardiograms (ECG) obtained in triplicate and reviewed by independent blinded cardiologist, and Karnofsky's performance status.

Study Design

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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

Arms and Interventions

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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.

Outcome Measures

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Primary Outcome Measures :

1. 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).
2. 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.

Secondary Outcome Measures :

1. 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).
2. 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.

Other Outcome Measures:

1. 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.
2. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 99 Years (Adult, Senior)
Sexes 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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Morphotek
ClinicalTrials.gov Identifier:	NCT00738699 History of Changes
Other Study ID Numbers:	MORAb003-003PR
First Posted:	August 20, 2008
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