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This is a Phase 1, dose escalation study evaluating safety and pharmacokinetics of enteric coated D-3263 HCl in subjects with advanced solid tumors
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EC D-3263 HCl | Drug | EC D-3263 HCl, capsules, 50 mg. Oral administration. Dose escalation cohorts (cycle one: single dose on Day 1, daily doses on day 8-28; subsequent cycles: 1 week drug holiday followed by 3 weeks of daily dosing). Expansion Cohort: daily dosing for 28 days followed by a single 7 day drug holiday (Cycle 1), continuing thereafter with daily dosing. |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety of EC D-3263 HCl | weekly | |
| Determine the maximum tolerated dose of EC D-3263 HCl administered orally daily | weekly |
| Measure | Description | Time Frame |
|---|---|---|
| Characterize the pharmacokinetic profile of EC D-3263 HCl after a single dose and repeat daily dosing | periodically within the first month, weekly thereafter | |
| preliminary assessment of antitumor activity | 1 month, periodically thereafter |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Texas Accelerated Research Therapeutics (START) | San Antonio | Texas | 78229 | United States |
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