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

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 Overview

• Status: Completed
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: EC D-3263 HCl

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • South Texas Accelerated Research Therapeutics (START)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assess the safety of EC D-3263 HCl	weekly
Determine the maximum tolerated dose of EC D-3263 HCl administered orally daily	weekly

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Dendreon

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: February 6, 2009
• First Submitted That Met QC Criteria: February 6, 2009
• First Posted (Estimate): February 9, 2009

Study Record Updates

• Last Update Posted (Estimate): May 2, 2012
• Last Update Submitted That Met QC Criteria: April 30, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: subjects with advanced solid tumors refractory to standard therapy or for whom no effective therapy is available.
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: T08-1