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AMP-011 is a Phase 1 study designed to extend the understanding of the toxicity and pharmacology of imexon by investigating a schedule of daily treatment for 5 days every three weeks. The objective of the study is to determine the maximally tolerated dose, the pharmacokinetics, and the toxicity of the drug on the designated schedule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| imexon | Experimental | Dose escalation of imexon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| imexon | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the maximally tolerated dose | ||
| determine the pharmacokinetics | ||
| determine the toxicity of the drug on the designated schedule |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evan Hersh, MD | AmpliMed Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| US Oncology Indiana | Indianapolis | Indiana | 46227 | United States | ||
| US Oncology Albany, New York Oncology |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C014919 | 4-imino-1,3-diazabicyclo(3.1.0)hexan-2-one |
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| Albany |
| New York |
| 12208 |
| United States |
| Investigational Site 014 | Temple | Texas | 76508 | United States |
| US Oncology, Tyler Cancer Center | Tyler | Texas | 75702 | United States |