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

NCT ID: NCT00839631

Last Updated: 2012-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2012-04-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dendreon

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, United States

Countries

United States

Other Identifiers

T08-1

Identifier Type: -

Identifier Source: org_study_id