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| Sponsor: | Eisai Inc. |
|---|---|
| Information provided by: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00121680 |
Purpose
The purpose of this study is to study the safety of E7080 administered to patients with solid tumors or lymphomas.
Please note: this study is now recruiting patients with advanced and/or metastatic melanoma only.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma Neoplasms Solid Tumors |
Drug: E7080 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
| Official Title: | An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors or Lymphomas |
| Estimated Enrollment: | 50 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: E7080
Oral.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Please note: this study is now recruiting patients with advanced and/or metastatic melanoma only.
Inclusion Criteria:
Patients must meet all of the inclusion criteria outlined below in order to be eligible to participate in the study.
Exclusion Criteria:
Patients with the following characteristics will not be eligible for the study:
Any of the following laboratory parameters:
Women who are pregnant or breast-feeding; women of childbearing potential with a positive pregnancy test at Screening or no pregnancy test. Women of childbearing potential unless
Contacts and Locations| Contact: Eisai Medical Services | 1-888-422-4743 |
| United States, Texas | |
| Mary Crowley Medical Research Center | Recruiting |
| Dallas, Texas, United States | |
| MD Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Study Director: | Barbara Koetz, MRCP, MSc | Eisai Limited |
More Information
| Responsible Party: | Eisai Limited ( Barbara Koetz, MRCP, MSc ) |
| Study ID Numbers: | E7080-A001-102 |
| Study First Received: | July 15, 2005 |
| Last Updated: | September 1, 2009 |
| ClinicalTrials.gov Identifier: | NCT00121680 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Lymphatic Diseases Neoplasms Immunoproliferative Disorders Neoplasms by Histologic Type |
Immune System Diseases Lymphoproliferative Disorders Lymphoma |