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This is a Phase I, dose escalation study of EM-1421 administered by intravenous infusion (IV) for five consecutive days every 28 days to patients with solid tumors refractory to current therapies. There have been no previous human studies of intravenous (into one's vein) EM-1421 treatment; however, lab research (research in test tubes and/or animals) suggests that EM-1421 has shown some activity against tumors in animals. This activity in animal models suggests that EM-1421 may be a useful chemotherapy for human cancer.
The primary objective of this study is to determine the safety and maximum tolerated dose of EM-1421 given by intravenous infusion. The efficacy of the treatment will also be measured.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EM-1421 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | ||
| Maximum tolerated dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters | ||
| Pharmacodynamic parameters | ||
| Anti-tumor activity of regimen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Neil Frazer, MB | Erimos Pharmaceuticals |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premiere Oncology of Arizona | Scottsdale | Arizona | United States | |||
| Albert Einstein College of Medicine |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C076852 | terameprocol |
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| Feasibility of regimen |
| The Bronx |
| New York |
| United States |
| Sarah Cannon Cancer Center | Nashville | Tennessee | United States |