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This is a study to assess the safety and tolerability of SNS-314 in advanced solid tumors in humans.
Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the blood).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalating cohorts of SNS-314 | Experimental | Sequential groups, starting at a dose of 30 mg/m2, will be escalated according to identification of dose limiting toxicities against various criteria. Doses escalated by doubling the dose until the first observation of clinically significant Grade 2 or greater toxicity related to SNS-314 injection. Results in dosing increments of 67%, 50%, 40%, 33%, and subsequently 25% based on modified Fibonacci schema. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNS-314 | Drug | Stage 1 - Escalating doses of SNS-314 Injection on days 1, 8 and 15 Stage 2 - Same as stage 1 except SNS-314 Injection is administered at the maximum tolerated dose established in stage 1 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of SNS-314 | 1 Year |
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Inclusion Criteria:
Exclusion Criteria:
Please note: There are additional inclusion/exclusion criteria for this study. Please contact the study center for additional information and to determine if all study criteria are met.
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| Name | Affiliation | Role |
|---|---|---|
| Glenn Michelson, MD | Sunesis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama, Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Stanford University Medical Center |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C532454 | SNS 314 |
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| Stanford |
| California |
| 94305 |
| United States |
| University of New Mexico | Albuquerque | New Mexico | 87131 | United States |
| Duke University | Durham | North Carolina | 27710 | United States |