Status:
COMPLETED
Dose Escalation Study of EC D-3263 HCl in Advanced Solid Tumors
Lead Sponsor:
Dendreon
Conditions:
Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00839631
Start Date
March 1 2009
End Date
April 1 2012
Last Update
May 2 2012
Active Locations (1)
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1
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States, 78229