CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 106 enrolled
Drug / intervention
E7389 28 Day Cycle +1 moredrug
Likely dose
E7389 1.4 mg/m² IV bolus on Days 1, 8, and 15 of a 28-day cycle, or Days 1 and 8 of a 21-day cycleAI-extracted
Key inclusion· 8
  • ✓Histologically or cytologically confirmed advanced NSCLC with at least one measurable site by RECIST
  • ✓Prior progression during or after platinum-containing doublet chemotherapy
  • ✓Age ≥18 years
  • ✓ECOG performance status 0 or 1
Key exclusion· 9
  • ✕Pre-existing peripheral neuropathy >Grade 2
  • ✕Requirement for therapeutic warfarin dosing
  • ✕Active symptomatic brain metastases
  • ✕Positive history for HIV, active hepatitis B or C

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

Search/NCT00100932
NCT00100932Phase 2Completed
CompareCT.gov

Phase II Study of E7389, a Halichondrin B Analog, in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC), Who Progressed During or After Platinum-Based Doublet Chemotherapy Stratified for Prior Taxane Therapy

Eisai Inc.·interventional·Posted Jan 10, 2005·Updated Mar 27, 2012

In Brief

A Phase 2 clinical trial evaluating E7389 28 Day Cycle and E7389 21 Day Cycle for Non-Small-Cell Lung Carcinoma. Completed, enrolled 106 participants across 13 sites.

Detailed Summary

This is a study of E7389 in patients with recurrent and/or metastatic Non-Small-Cell Lung Cancer (NSCLC) who progressed during or after treatment with a platinum agent and another chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small-Cell Lung Carcinoma
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 10, 2005
Enrollment StartDec 1, 2004
Primary CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 21.5 years ago

Interventions

E7389 28 Day Cycledrug

E7389 1.4 mg/m\^2 IV bolus on Days 1, 8, and 15 of a 28 day cycle.

E7389 21 Day Cycledrug

E7389 1.4 mg/m\^2 IV bolus on Days 1 and 8 of a 21 day cycle.