This is a Phase 1, dose escalation study evaluating safety and pharmacokinetics of enteric coated D-3263 HCl in subjects with advanced solid tumors
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
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.
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States
Assess the safety of EC D-3263 HCl
Time frame: weekly
Determine the maximum tolerated dose of EC D-3263 HCl administered orally daily
Time frame: weekly
Characterize the pharmacokinetic profile of EC D-3263 HCl after a single dose and repeat daily dosing
Time frame: periodically within the first month, weekly thereafter
preliminary assessment of antitumor activity
Time frame: 1 month, periodically thereafter
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