Efficacy and Safety of MORAb-003 in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse
Tracking Information
Start Date ICMJE | March 2009 |
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Estimated Primary Completion Date | September 2012 (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 |
Descriptive Information
Brief Title ICMJE | Efficacy and Safety of MORAb-003 in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse |
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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 | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Ovarian Cancer |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 900 | ||||
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Completion Date | |||||
Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Australia, Belgium, Canada, Chile, Greece, Hong Kong, Hungary, India, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Philippines, Poland, Portugal, Russian Federation, Singapore, Spain, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00849667 |
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Responsible Party | Susan Weil, M.D. /Study Medical Monitor, Morphotek, Inc |
Study ID Numbers ICMJE | MORAb003-004 |
Study Sponsor ICMJE | Morphotek |
Collaborators ICMJE | |
Investigators ICMJE | |
Information Provided By | Morphotek |
Source: http://clinicaltrials.gov/