Efficacy and Safety of MORAb-003 in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Morphotek

ClinicalTrials.gov Identifier:

NCT00849667

First received: February 13, 2009

Last updated: May 2, 2013

Last verified: May 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	February 13, 2009
Last Updated Date	May 2, 2013
Start Date ^ICMJE	March 2009
Estimated Primary Completion Date	July 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 20, 2009)	Progression-free survival using by RECIST [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00849667 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 20, 2009)	Overall Survival, CA-125 PFS, GCIG PFS, Length of first versus second remission, Tumor Response,Serologic Response (CA-125), Quality of Life, Resource utilization and PK DDI substudy. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of MORAb-003 in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse
Official Title ^ICMJE	A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly MORAb-003 in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse
Brief Summary	This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive relapsed ovarian cancer.
Detailed Description	Not Provided
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) MORAb-003 1.25 mg/kg infusions will take place weekly during combination therapy and then as single agent maintenance until progression. Drug: MORAb-003 (farletuzumab) MORAb-003 2.5mg/kg infusions will take place weekly during combination therapy and then as single agent maintenance until progression. Drug: 0.9% Saline 0.9% infusions will take place weekly during combination therapy and then as single agent maintenance until progression.
Study Arm (s)	Active Comparator: 1 Carboplatin and taxane with MORAb-003 1.25 mg/kg Intervention: Drug: MORAb-003 (farletuzumab) Active Comparator: 2 Carboplatin and taxane with MORAb-003 2.5 mg/kg Intervention: Drug: MORAb-003 (farletuzumab) Placebo Comparator: 3 Carboplatin and taxane with Placebo Intervention: Drug: 0.9% Saline
Publications *	Not Provided
* 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	Active, not recruiting
Estimated Enrollment ^ICMJE	1080
Estimated Completion Date	July 2013
Estimated Primary Completion Date	July 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: A histologically or cytologically confirmed diagnosis of non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies Must have measurable disease by CT or MRI scan Must have relapsed radiologically with a randomization date within ≥6 and < 24 months of completion of first-line platinum chemotherapy Have been treated with debulking surgery and first-line platinum and taxane based chemotherapy. Prior bevacizumbab maintenance is allowed. The last dose of bevacizumab must have been at least 30 days before study Day 1. No cytotoxic maintenance therapy (e.g. taxane) or cancer vaccine therapy is allowed. Must be a candidate for carboplatin and taxane therapy Neurologic function: neuropathy (sensory and motor) ≤CTCAE Grade 1 Exclusion Criteria: Subjects who never responded to first-line platinum-based therapy or whose first relapse occurs <6 months or >24 months from the last platinum therapy Subjects who have received other therapy to treat their ovarian cancer since relapse Known central nervous system (CNS) tumor involvement Evidence of other active invasive malignancy requiring treatment in the past 5 years Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA Previous treatment with MORAb-003 (farletuzumab) Clinical contraindications to use of a taxane
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, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Philippines, Poland, Portugal, Russian Federation, Singapore, Spain, Switzerland, Taiwan, Ukraine, United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00849667
Other Study ID Numbers ^ICMJE	MORAb003-004
Has Data Monitoring Committee	Yes
Responsible Party	Morphotek
Study Sponsor ^ICMJE	Morphotek
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Morphotek
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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