Dose Escalation Study of EC D-3263 HCl in Advanced Solid Tumors

Dendreon

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: EC D-3263 HCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT00839631

T08-1

Details and patient eligibility

About

This is a Phase 1, dose escalation study evaluating safety and pharmacokinetics of enteric coated D-3263 HCl in subjects with advanced solid tumors

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)