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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00839631
Other study ID # T08-1
Secondary ID
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


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
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