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| Sponsor: | Eisai Inc. |
|---|---|
| Information provided by: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00794781 |
Purpose
The purpose of this study is to determine the maximum tolerated dose (MTD), safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of E6201 in subjects with advanced solid tumors.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Solid Tumors |
Drug: E6201 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, and Pharmacodynamic Study of E6201 in Subjects With Advanced Solid Tumors |
| Estimated Enrollment: | 65 |
| Study Start Date: | June 2008 |
| Estimated Study Completion Date: | June 2012 |
| Estimated Primary Completion Date: | April 2012 (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:
Subjects must meet all of the following criteria to be eligible to participate in this study:
Adequate bone marrow function defined as:
Adequate renal function defined as:
Adequate liver function defined as:
Additionally, subjects enrolled in Part B (MTD expansion) of the study MUST meet the following criteria:
Exclusion Criteria:
Subjects who meet any of the following criteria are not eligible to participate in this study:
Contacts and Locations| Contact: Eisai Medical Services Oncology | 1-877-873-4724 |
| United States, Arizona | |
| Recruiting | |
| Scottsdale, Arizona, United States | |
| United States, California | |
| Recruiting | |
| Los Angeles, California, United States | |
| United States, Nevada | |
| Recruiting | |
| Las Vegas, Nevada, United States | |
| United States, New Hampshire | |
| Recruiting | |
| Lebanon, New Hampshire, United States | |
| United States, New York | |
| Recruiting | |
| Albany, New York, United States | |
| United States, South Carolina | |
| Recruiting | |
| Greenville, South Carolina, United States | |
| United States, Texas | |
| Recruiting | |
| Austin, Texas, United States | |
| Recruiting | |
| Dallas, Texas, United States | |
| Recruiting | |
| San Antonio, Texas, United States | |
| Recruiting | |
| Tyler, Texas, United States | |
| United States, Virginia | |
| Recruiting | |
| Norfolk, Virginia, United States | |
| United States, Washington | |
| Not yet recruiting | |
| Vancouver, Washington, United States | |
| Study Director: | Eisai Medical Services | Eisai Inc. |
More Information
| Responsible Party: | Eisai US Medical Services, Eisai Medical Research Inc. |
| ClinicalTrials.gov Identifier: | NCT00794781 History of Changes |
| Other Study ID Numbers: | E6201-A001-102 |
| Study First Received: | November 19, 2008 |
| Last Updated: | March 31, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Cancer solid tumors |
|
Neoplasms |