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

NCT00839631 | Completed Phase 1

• 1 other identifier: T08-1
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Conditions

Solid Tumors

Keywords

subjects with advanced solid tumors refractory to standard therapy or for whom no effective therapy is available.

Outcome Measures

Primary Outcomes (2)

• Assess the safety of EC D-3263 HCl

  weekly

• Determine the maximum tolerated dose of EC D-3263 HCl administered orally daily

  weekly

Secondary Outcomes (2)

• 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

Interventions

EC D-3263 HCl DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dendreon: lead

Study Sites (1)

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, 78229, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 9, 2009
• Study Start: March 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: April 1, 2012
• Last Updated: May 2, 2012

Record last verified: 2012-04

Locations

US (1)