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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dendreon
ClinicalTrials.gov Identifier:
NCT00839631
First received: February 6, 2009
Last updated: April 30, 2012
Last verified: April 2012
History of Changes
  Purpose

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: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Dendreon:

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

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 ] [ Designated as safety issue: Yes ]
  • preliminary assessment of antitumor activity [ Time Frame: 1 month, periodically thereafter ] [ Designated as safety issue: No ]

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839631

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

No publications provided

Responsible Party: Dendreon
ClinicalTrials.gov Identifier: NCT00839631     History of Changes
Other Study ID Numbers: T08-1
Study First Received: February 6, 2009
Last Updated: April 30, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on June 18, 2013