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Tracking Information | |||||
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First Received Date † | May 2, 2002 | ||||
Last Updated Date | December 9, 2008 | ||||
Start Date † | |||||
Current Primary Outcome Measures † |
Maximum tolerated dose | ||||
Original Primary Outcome Measures † |
Response | ||||
Change History | Complete list of historical versions of study NCT00035100 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | EPO906 Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer | ||||
Official Title † | An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Ovarian, Primary Fallopian, or Primary Peritoneal Cancer | ||||
Brief Summary | This study will examine whether the new investigational drug EPO906, given by intravenous infusion (IV directly into the vein), is effective in shrinking tumors and preventing the growth of cells that cause ovarian, fallopian, or peritoneal cancers. Recruitment in the United States is complete but the study is still enrolling in other countries. |
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Detailed Description | |||||
Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study | ||||
Condition † |
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Intervention † | Drug: epothilone b | ||||
Study Arms / Comparison Groups | |||||
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 † | Completed | ||||
Enrollment † | 48 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria The following patients may be eligible for the study:
Exclusion Criteria The following patients are not eligible for the study:
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Gender | Female | ||||
Ages | 18 Years to 85 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00035100 | ||||
Responsible Party | External Affairs, Novartis | ||||
Secondary IDs †† | |||||
Study Sponsor † | Novartis | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Novartis | ||||
Verification Date | December 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |