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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 19, 2003 | ||||
| Last Updated Date | September 8, 2009 | ||||
| Start Date ICMJE | August 2003 | ||||
| Primary Completion Date | July 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00069264 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Study of E7389 in Patients With Advanced Solid Tumors | ||||
| Official Title ICMJE | A Phase I Dose-Finding Study of E7389 (Halichondrin B Analog) in Patients With Advanced Solid Tumors | ||||
| Brief Summary | To determine the maximum tolerated dose of E7389 in patients with advanced solid tumors that have progressed following standard therapy or for which no standard therapy exists. |
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| Detailed Description | |||||
| Study Phase | Phase I | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study | ||||
| Condition ICMJE | Advanced Solid Tumors | ||||
| Intervention ICMJE | Drug: E7389 | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* 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 ICMJE | Completed | ||||
| Enrollment ICMJE | 55 | ||||
| Completion Date | July 2005 | ||||
| Primary Completion Date | July 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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| Gender | Both | ||||
| 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 | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00069264 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | E7389-A001-101, E7389, BOLD | ||||
| Study Sponsor ICMJE | Eisai Inc. | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Eisai Inc. | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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