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The goal of this clinical research study is to find the highest tolerable dose of EZN-2208 that can be given to patients with advanced cancer or lymphoma. The safety of the study drug and its effect on the disease will also be studied.
Enzon will also perform pharmacokinetic (PK) testing of EZN-2208. PK testing measures the amount of a drug in the body at different time points.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EZN-2208 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Determine the MTD of i.v. EZN-2208 administered q3wk and recommended Phase 2 dose of i.v. EZN-2208 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety and tolerability of EZN-2208, assess the pharmacokinetic PK profile of EZN-2208, SN38, and SN38G as well as detect preliminary evidence of tumor response activity of EZN-2208 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Razelle Kurzrock, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Mary Frances Mulcahy, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University, Feinberg School of Medicine, Division of Hematology/Oncology | Chicago | Illinois | 60611-2927 | United States | ||
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| MD Anderson Cancer Center |
| Houston |
| Texas |
| 77030 |
| United States |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C528970 | EZN-2208 |
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