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

This study has been completed.
Information provided by (Responsible Party):
Dendreon Identifier:
First received: February 6, 2009
Last updated: April 30, 2012
Last verified: April 2012
This is a Phase 1, dose escalation study evaluating safety and pharmacokinetics of enteric coated D-3263 HCl in subjects with advanced solid tumors

Condition Intervention Phase
Solid Tumors Drug: EC D-3263 HCl Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Dendreon:

Primary Outcome Measures:
  • Assess the safety of EC D-3263 HCl [ Time Frame: weekly ]
  • Determine the maximum tolerated dose of EC D-3263 HCl administered orally daily [ Time Frame: weekly ]

Secondary Outcome Measures:
  • Characterize the pharmacokinetic profile of EC D-3263 HCl after a single dose and repeat daily dosing [ Time Frame: periodically within the first month, weekly thereafter ]
  • preliminary assessment of antitumor activity [ Time Frame: 1 month, periodically thereafter ]

Enrollment: 23
Study Start Date: March 2009
Study Completion Date: April 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00839631

United States, Texas
South Texas Accelerated Research Therapeutics (START)
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
  More Information

Responsible Party: Dendreon Identifier: NCT00839631     History of Changes
Other Study ID Numbers: T08-1
Study First Received: February 6, 2009
Last Updated: April 30, 2012

Keywords provided by Dendreon:
subjects with advanced solid tumors refractory to standard therapy or for whom no effective therapy is available. processed this record on September 21, 2017