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

Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00839631
• Other study ID #: T08-1
• Status: Completed
• Phase: Phase 1
• First received: February 6, 2009
• Last updated: April 30, 2012
• Start date: March 2009
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: Dendreon
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumors

Intervention

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.

Locations

Country	Name	City	State
United States	South Texas Accelerated Research Therapeutics (START)	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Dendreon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the safety of EC D-3263 HCl		weekly	Yes
Primary	Determine the maximum tolerated dose of EC D-3263 HCl administered orally daily		weekly	Yes
Secondary	Characterize the pharmacokinetic profile of EC D-3263 HCl after a single dose and repeat daily dosing		periodically within the first month, weekly thereafter	Yes
Secondary	preliminary assessment of antitumor activity		1 month, periodically thereafter	No