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

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ClinicalTrials.gov Identifier: NCT00839631
Recruitment Status : Completed
First Posted : February 9, 2009
Last Update Posted : May 2, 2012
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment Phase
Solid Tumors Drug: EC D-3263 HCl Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
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
Study Start Date : March 2009
Primary Completion Date : December 2011
Study Completion Date : April 2012
Arms and Interventions

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.

Outcome Measures

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

Secondary Outcome Measures :
  1. 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 ]
  2. preliminary assessment of antitumor activity [ Time Frame: 1 month, periodically thereafter ]

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00839631

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

Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT00839631     History of Changes
Other Study ID Numbers: T08-1
First Posted: February 9, 2009    Key Record Dates
Last Update Posted: May 2, 2012
Last Verified: April 2012

Keywords provided by Dendreon:
subjects with advanced solid tumors refractory to standard therapy or for whom no effective therapy is available.