NCT00839631

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

A Phase 1, Open Label, Dose Escalation Study Evaluating the Safety and Pharmacokinetics of Enteric Coated D-3263 Hydrochloride in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Dendreon · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	EC D-3263 HCl	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.

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-12-01
• Completion: 2012-04-01
• First posted: 2009-02-09
• Last updated: 2012-05-02

Locations

1 site across 1 country: United States