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| Sponsored by: |
Eisai Medical Research Inc. |
|---|---|
| Information provided by: | Eisai Medical Research 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: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | A Phase I Dose-Finding Study of E7389 (Halichondrin B Analog) in Patients With Advanced Solid Tumors |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential)
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 Medical Research Inc. |
More Information
| Study ID Numbers: | E7389-A001-101, E7389, BOLD |
| Study First Received: | September 19, 2003 |
| Last Updated: | January 29, 2008 |
| ClinicalTrials.gov Identifier: | NCT00069264 History of Changes |
| 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 |
|
Signs and Symptoms Neoplasm Metastasis Recurrence |