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| Sponsor: | Eisai Inc. |
|---|---|
| Information provided by: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00069264 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors |
Drug: E7389 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase I Dose-Finding Study of E7389 (Halichondrin B Analog) in Patients With Advanced Solid Tumors |
| Enrollment: | 33 |
| Study Start Date: | September 2003 |
| Study Completion Date: | July 2005 |
| Primary Completion Date: | March 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: E7389 |
Drug: E7389
E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations| United States, New York | |
| Bronx, New York, United States, 10461 | |
| United States, Texas | |
| San Antonio, Texas, United States | |
| Study Director: | Dale Shuster, Ph.D. | Eisai Inc. |
More Information
| ClinicalTrials.gov Identifier: | NCT00069264 History of Changes |
| Other Study ID Numbers: | E7389-A001-101, E7389, BOLD |
| Study First Received: | September 19, 2003 |
| Results First Received: | November 16, 2011 |
| Last Updated: | November 16, 2011 |
| Health Authority: | United States: Food and Drug Administration |
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Metastatic Tumors Advanced Solid Tumors Stage IV Tumors Solid Tumors Recurrent Solid Tumors |
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Neoplasms |