Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the maximum tolerated dose (MTD) of E7974 after bolus IV administration, on Day 1 of a 21-day cycle, to patients with advanced solid tumors that have progressed following effective therapy or for which no effective therapy exists.
The MTD for the Day 1 21-Day schedule was defined at the 0.45 mg/m2 dose level. The study was terminated prior to full enrollment of the colorectal cancer (CRC) expansion cohort, due to a lack of demonstrated activity resulting in Principal Investigator (PI) loss interest to continue enrollment. Collection of all outstanding data is ongoing and database lock is estimated to be complete in June 2008.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E7974 | Drug | Maximum Tolerated Dose defined as 0.45 mg/m^2 administered on Day 1 only of a 21-day cycle; the E7974 compound is administered as a bolus infusion; no placebo is given. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the maximum tolerated dose of E7974 in patients with Advanced Solid Tumors. | Duration of each cycle will be 21 days; patients will attend a follow-up visit 30 days after last study treatment. Follow-up for safety and efficacy will occur 6 months after the last patient is accrued to the study. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess E7974 for safety, pharmacokinetics (PK) and pharmacodynamics (PD) which will correlate AUC with clinical toxicity and efficacy. | Duration of each cycle will be 21 days; patients will attend a follow-up visit 30 days after last study treatment. Follow-up for safety and efficacy will occur 6 months after the last patient is accrued to the study. |
Not provided
Inclusion Criteria: At this time, we are only enrolling patients for the MTD cohort that meet all study entry criteria, plus the CRC criterion (Inclusion Criterion #12).Patients who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for entry into the study. Patients must:
Exclusion Criteria:The presence of one or more of the following criteria will disqualify a patient from enrollment in the study:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jenny Zhang | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sylvester Comprehensive Cancer Center - University of Miami | Miami | Florida | 33136 | United States | ||
| Cancer Institute Of New Jersey |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C546192 | E 7974 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| New Brunswick |
| New Jersey |
| 08903-2681 |
| United States |