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The purpose of this study is to determine the maximum tolerated dose (MTD) of E7974 administered on Days 1 and 15 of a 28-day cycle in subjects with solid malignancies that have progressed following effective therapy or for which no effective therapy exists.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E7974 | Drug | Maximum Tolerated Dose defined as 0.35 mg/m^2 administered on Days 1 and 15 only of a 28-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 solid malignancies. | Duration of each cycle will be 28 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, efficacy, pharmacokinetics and pharmacodynamics; evaluate the efficacy of E7974 in patients with metastatic, refractory prostate cancer. | Duration of each cycle will be 28 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. |
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Inclusion Criteria:
Patients who meet all of the inclusion criteria and none of the exclusion criteria will be eligible for entry into the study:
For Prostate Cancer patients only being enrolled at the MTD expansion phase:
Exclusion Criteria:The presence of one or more of the following criteria will disqualify a patient from enrollment in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Naseem Zojwalla, M.D. | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nevada Cancer Institute | Las Vegas | Nevada | 89135 | United States | ||
| University Hospital Medical Center - SUNY at Stony Brook |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C546192 | E 7974 |
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| Stony Brook |
| New York |
| 11794 |
| United States |