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The purpose of this study is to determine the safety and the maximum tolerated dose of GRN163L administration in treating patients with refractory or relapsed solid tumor malignancies.
GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in antineoplastic effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation | Experimental | Treatment Schedule 3 will consist of dosing on Days 1, 4, 8, and 11 of each 21 day cycle (3 weeks equals 1 cycle) and Treatment Schedule 4 will consist of dosing on Day 1 of each 28 day cycle (4 weeks equals 1 cycle) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imetelstat Sodium (GRN163L) | Drug | Dose increase by 25% if tolerated infused over 2 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety, DLT, and MTD | Measured during the first cycle of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| PK profile and disease response | Within the first 2 cycles of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | United States | ||
| Wayne State University, Karmanos Cancer Center |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C519562 | imetelstat |
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| Detroit |
| Michigan |
| 48201 |
| United States |