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The primary objective is to determine the safety and maximum tolerated dose (MTD) of Genasense administered as a 2-hour intravenous infusion once weekly (Part 1) and twice weekly (Part 2) to patients with solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental | Cohort 1- Genasense will be administered as a 2-hour intravenous infusion once weekly for 3 weeks at a dose of 300 mg to the first subject enrolled and, in the absence of dose-limiting toxicity, in increasing increments of 100 mg to each successive subject enrolled to a maximum dose of 1000 mg. |
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| Part 2 | Experimental | Genasense will be administered as a 2-hour intravenous infusion twice weekly for 3 weeks at a dose established based on Part 1 of the study. |
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| Cohort 2 | Experimental | Also in Part 1 of the study, Genasense will be administered as a 2-hour intravenous infusion once weekly for 3 weeks at a starting dose of 1100 mg and increasing in increments of 100 mg to the MTD. Patients will be pretreated with a corticosteroid. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oblimersen (Genasense) | Drug | Intravenous |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) of Genasense administered as a 2-hour IV infusion once a week (Part 1) and twice a week (Part 2) to patients with solid tumors | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (Part 1 and Part 2); pharmacodynamics (Part 2) | During treatment phase |
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Inclusion Criteria:
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Texas Accelerated Research Therapeutics | San Antonio | Texas | 78229 | United States |
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| ID | Term |
|---|---|
| C408162 | oblimersen |
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| Oblimersen (Genasense) | Drug | Intravenous |
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