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| Sponsor: | Eisai Inc. |
|---|---|
| Information provided by: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00069277 |
Purpose
The malignancies (advanced solid tumors) that have been chosen for evaluation of E7389 are those where E7389 has demonstrated significant pre-clinical anti-tumor activity, both in vitro and in vivo. The ultimate goal is to demonstrate the clinical activity of E7389 in the treatment of these, and potentially other, tumor types.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
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) Administered Once Every Three Weeks in Patients With Advanced Solid Tumors |
| Enrollment: | 35 |
| Study Start Date: | August 2003 |
| Study Completion Date: | April 2005 |
| Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
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, California | |
| Cancer Institute Medical Group | |
| Los Angeles, California, United States, 90025 | |
| Premiere Oncology | |
| Santa Monica, California, United States, 90404 | |
| United States, New Jersey | |
| New Brunswick, New Jersey, United States, 08901 | |
| Study Director: | Dale Schuster, Ph.D | Eisai Inc. |
More Information
| Responsible Party: | Dale Shuster, Ph.D, Eisai Medical Research |
| ClinicalTrials.gov Identifier: | NCT00069277 History of Changes |
| Other Study ID Numbers: | E7389-A001-102 |
| Study First Received: | September 19, 2003 |
| Results First Received: | January 9, 2012 |
| Last Updated: | January 9, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
Cancer, tumors |