CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 33 enrolled
Drug / intervention
E7389drug
Likely dose
E7389 0.25 mg/m² intravenous on Days 1, 8, and 15 of a 28-day cycleAI-extracted
Key inclusion· 7
  • Histologically or cytologically confirmed measurable advanced solid tumor that has progressed after standard therapy or for which no standard therapy exists
  • Age >18 years
  • Karnofsky Performance Status >70%
  • Life expectancy >3 months
Key exclusion· 12
  • Chemotherapy within 3 weeks (or 6 weeks if nitrosoureas) before E7389 treatment start
  • Unrecovered chemotherapy or prior therapy-related toxicity at study entry
  • Active anti-coagulant therapy requirement
  • Pregnancy, breastfeeding, or women of childbearing potential without adequate contraception

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

Search/NCT00069264
NCT00069264Phase 1Completed

A Phase I Dose-Finding Study of E7389 (Halichondrin B Analog) in Patients With Advanced Solid Tumors

Eisai Inc.·interventional·Posted Sep 24, 2003·Updated Dec 20, 2011

In Brief

A Phase 1 clinical trial evaluating E7389 for Advanced Solid Tumors. Completed, enrolled 33 participants across 2 sites.

Detailed Summary

To determine the maximum tolerated dose of E7389 in patients with advanced solid tumors that have progressed following standard therapy or for which no standard therapy exists.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 24, 2003
Enrollment StartSep 1, 2003
Primary CompletionMar 1, 2005
Study CompletionJul 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 22.8 years ago

Interventions

E7389drug

E7389 Dose-escalation starting at 0.25 mg/m\^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.