An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer - Tabular View

Tracking Information
First Received Date ^ICMJE	August 18, 2008
Last Updated Date	April 19, 2012
Start Date ^ICMJE	September 2008
Estimated Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 19, 2012)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: August 18, 2008)	Progression-free survival using GCIG response criteria [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00738699 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 19, 2012)	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.
Original Secondary Outcome Measures ^ICMJE (submitted: August 18, 2008)	overall response,overall survival and cardiac substudy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Descriptive Information
Brief Title ^ICMJE	An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer
Official Title ^ICMJE	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
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
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Ovarian Cancer
Intervention ^ICMJE	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 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
Study Arms	Active Comparator: 1 Paclitaxel with MORAb-003(farletuzumab) Intervention: Drug: MORAb-003 (farletuzumab) Placebo Comparator: 2 Paclitaxel with Placebo Intervention: Drug: 0.9% Saline
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	417
Estimated Completion Date	April 2012
Estimated Primary Completion Date	April 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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).
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Australia, Belgium, Canada, Netherlands, Spain

Administrative Information
NCT Number ^ICMJE	NCT00738699
Other Study ID Numbers ^ICMJE	MORAb003-003PR
Has Data Monitoring Committee	Yes
Responsible Party	( Morphotek )
Study Sponsor ^ICMJE	Morphotek
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Morphotek
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP