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Clinical Trial Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) of E7974 after bolus IV administration, on Day 1 of a 21-day cycle, to patients with advanced solid tumors that have progressed following effective therapy or for which no effective therapy exists.


Clinical Trial Description

The MTD for the Day 1 21-Day schedule was defined at the 0.45 mg/m2 dose level. The study was terminated prior to full enrollment of the colorectal cancer (CRC) expansion cohort, due to a lack of demonstrated activity resulting in Principal Investigator (PI) loss interest to continue enrollment. Collection of all outstanding data is ongoing and database lock is estimated to be complete in June 2008. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00165802
Study type Interventional
Source Eisai Inc.
Contact
Status Completed
Phase Phase 1
Start date May 2006
Completion date January 2009

See also
  Status Clinical Trial Phase
Completed NCT00130169 - A Phase 1 Open-Label Study of E7974 Administered on Days 1 and 15 of a 28-Day Cycle in Patients With Solid Malignancies Phase 1