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The purpose of this study is to determine the maximum tolerated dose (MTD) of E7974 administered as an intravenous bolus dose on Days 1, 8, and 15 of a 28-day cycle (Arm A) or on Days 1 and 8 of a 21-day cycle (Arm B) to patients with solid tumors that have progressed following effective therapy or for which no effective therapy exists.
This is a two-arm, open-label, non-randomized, dose-escalation study to determine the MTD of E7974 administered as an intravenous bolus dose on Days 1, 8, and 15 of a 28-day cycle (Arm A) or on Days 1 and 8 of a 21-day cycle (Arm B) to patients with solid tumors that have progressed following effective therapy or for which no effective therapy exists. Response and progression will be evaluated in this study using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E7974 | Drug | Maximum tolerated dose = 0.15 mg/m^2 administered on Days 1, 8, 15 of 28-day cycle. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the maximum tolerated dose of E7974 in patients with solid malignancies. | Duration of each cycle will be 28 or 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 |
|---|---|---|
| 1) Assess E7974 for safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD); 2) Evaluate the correlation of AUC with clinical toxicity and efficacy in both arms. | Duration of each cycle will be 28 or 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. |
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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:
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 |
|---|---|---|
| Jenny Zhang, M.D. | Eisai Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States | ||
| CTRC |
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| E7974 |
| Drug |
Maximum tolerated dose = 0.37 mg/m^2 administered on Days 1 and 8 of 21-day cycle. |
|
| San Antonio |
| Texas |
| 78229 |
| United States |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C546192 | E 7974 |
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