Dose Escalation Study of EC D-3263 HCl in Advanced Solid Tumors
Phase 1
Completed
- Conditions
- Solid Tumors
- Registration Number
- NCT00839631
- Lead Sponsor
- Dendreon
- Brief Summary
This is a Phase 1, dose escalation study evaluating safety and pharmacokinetics of enteric coated D-3263 HCl in subjects with advanced solid tumors
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
Inclusion Criteria
- histologically or cytologically confirmed advanced solid tumor malignancy which is either refractory to standard therapy or for which no standard therapy exists
- measurable or evaluable disease
- >= 18 years of age
- ECOG of 0, 1 or 2
- no treatement with chemotherapy, radiotherapy or other systemic therapy (excluding depot LHRH agonist or antagonist for subjects with prostate cancer) for the treatment of his or her tumor with in 28 days prior to receipt of EC D-3263 HCl
Exclusion Criteria
- Clinically significant coronary artery disease or conduction system abnormality
- Coagulation disorder
- Active infection requiring the use of systemic antimicrobial medications within seven days prior to receipt of EC D-3263 HCl
- Any major surgery within 28 days prior to receipt of EC D-3263 HCl
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Determine the maximum tolerated dose of EC D-3263 HCl administered orally daily weekly Assess the safety of EC D-3263 HCl weekly
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
South Texas Accelerated Research Therapeutics (START)
🇺🇸San Antonio, Texas, United States