CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 21 enrolled
Drug / intervention
E7389drug
Likely dose
Not stated in record
Key inclusion· 5
  • Histologically or cytologically confirmed, measurable advanced solid tumor that has progressed following standard therapy or for which no standard therapy exists
  • Prior chemotherapy allowed (maximum 2 prior regimens)
  • Age ≥18 years
  • Karnofsky Performance Status >70%
Key exclusion· 9
  • Chemotherapy within 3 weeks (6 weeks if nitrosoureas) of E7389 start
  • Unrecovered chemotherapy or therapy-related toxicity at study entry
  • Therapeutic doses of anticoagulant therapy (e.g., Coumadin, heparin, low molecular weight heparin)
  • Pregnant or breastfeeding women

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

Search/NCT00069277
NCT00069277Phase 1Completed

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

Eisai Inc.·interventional·Posted Sep 24, 2003·Updated Apr 11, 2012

In Brief

A Phase 1 clinical trial evaluating E7389 for Cancer. Completed, enrolled 21 participants across 3 sites.

Detailed Summary

The malignancies (advanced solid tumors) that have been chosen for evaluation of E7389 are those where E7389 has demonstrated significant pre-clinical anti-tumor activity, both in vitro and in vivo. The ultimate goal is to demonstrate the clinical activity of E7389 in the treatment of these, and potentially other, tumor types.

Study Details

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

Timeline

Phase 1CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 24, 2003
Enrollment StartAug 1, 2003
Primary CompletionApr 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 22.8 years ago

Interventions

E7389drug