CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 50 enrolled
Drug / intervention
ET 743drug
Likely dose
ET-743 administered intravenously by 24-hour infusion every 3 weeksAI-extracted
Key inclusion· 5
  • ✓Histologically confirmed adenocarcinoma of the prostate
  • ✓Radiographically documented metastatic disease
  • ✓Castration-resistant prostate cancer (CRPC) with PSA > 5 ng/ml despite surgical or chemical castration
  • ✓One previous taxane-based chemotherapy regimen
Key exclusion· 3
  • ✕Chemotherapy treatment within 4 weeks of study entry
  • ✕Serious medical conditions: uncontrolled congestive heart failure, myocardial infarction or active angina within 6 months, active infection, chronic active liver disease (hepatitis B/C or cirrhosis)
  • ✕Current treatment with non-FDA approved investigational drugs

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00147212
NCT00147212Phase 2Completed
CompareCT.gov

A Phase II Study of Three Hour, Weekly Infusion of ET 743 (Yondelis) in Men With Advanced Prostate Cancer

Massachusetts General Hospital·interventional·Posted Sep 7, 2005·Updated Jan 18, 2013

In Brief

A Phase 2 clinical trial evaluating ET 743 for Prostate Cancer. Completed, enrolled 50 participants across 2 sites.

Detailed Summary

The main purpose of this study is to find out what effects (good or bad) trabectedin (ET743) has on men with advanced prostate carcinoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsDana-Farber Cancer Institute, PharmaMar

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 7, 2005
Enrollment StartJun 1, 2002
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 20.8 years ago

Interventions

ET 743drug

ET-743 administered IV by 24-hr infusion every 3 weeks