NCT00165802

A Phase I Open Label Study of E7974 Administered on a Day 1 of 21-Day Cycle In Patients With Advanced Solid Tumors

A Phase I Open Label Study of E7974 Administered on Day 1 of a 21-Day Cycle In Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Cancer, Malignant Tumors

Interventions

Type	Name	Description
DRUG	E7974	Maximum Tolerated Dose defined as 0.45 mg/m\^2 administered on Day 1 only of a 21-day cycle; the E7974 compound is administered as a bolus infusion; no placebo is given.

Timeline

• Start date: 2006-05-01
• Primary completion: 2007-12-01
• Completion: 2009-01-01
• First posted: 2005-09-14
• Last updated: 2013-05-22

Locations

2 sites across 1 country: United States