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Completed

NCT Number: NCT00839631

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

This is a Phase 1, dose escalation study evaluating safety and pharmacokinetics of enteric coated D-3263 HCl in subjects with advanced solid tumors

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Key information

Conditions

Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, 78229, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EC D-3263 HCl

Drug

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Dendreon

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Feb 9, 2009
Registry last updated
May 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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