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Tracking Information | |||||
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First Received Date † | August 18, 2008 | ||||
Last Updated Date | May 4, 2009 | ||||
Start Date † | September 2008 | ||||
Current Primary Outcome Measures † |
Progression-free survival using GCIG response criteria [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00738699 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
overall response,overall survival and cardiac substudy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | An Efficacy and Safety Study of MORAb-003 in First Platinum-Resistant or Refractory Relapsed Ovarian Cancer | ||||
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 First Platinum-Resistant or Refractory Relapsed Ovarian Cancer | ||||
Brief Summary | This research is being done to find out if paclitaxel works better when given together with an experimental drug called MORAb-003(farletuzumab) or alone in patients with first platinum-resistant or refractory relapsed ovarian cancer |
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Detailed Description | |||||
Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Ovarian Cancer | ||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 126 | ||||
Estimated Completion Date | November 2011 | ||||
Estimated Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† |
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Location Countries † | United States, Australia, Canada | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00738699 | ||||
Responsible Party | Debasis Chakrabarti, M.D., PhD/ Study Director, Morphotek, Inc | ||||
Secondary IDs †† | |||||
Study Sponsor † | Morphotek | ||||
Collaborators †† | |||||
Investigators † | |||||
Information Provided By | Morphotek | ||||
Verification Date | December 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |