NCT00121732

An Open-Label Study of E7974 Administered on Days 1, 8, and 15 of a 28-Day Cycle and Days 1 and 8 of a 21-Day Cycle in Patients With Solid Malignancies

A Phase 1, Two-Arm, Open-Label Study of E7974 Administered on Days 1, 8, and 15 of a 28-Day Cycle and Days 1 and 8 of a 21-Day Cycle in Patients With Solid Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• 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 administered as an intravenous bolus dose on Days 1, 8, and 15 of a 28-day cycle (Arm A) or on Days 1 and 8 of a 21-day cycle (Arm B) to patients with solid tumors that have progressed following effective therapy or for which no effective therapy exists.

Detailed description

This is a two-arm, open-label, non-randomized, dose-escalation study to determine the MTD of E7974 administered as an intravenous bolus dose on Days 1, 8, and 15 of a 28-day cycle (Arm A) or on Days 1 and 8 of a 21-day cycle (Arm B) to patients with solid tumors that have progressed following effective therapy or for which no effective therapy exists. Response and progression will be evaluated in this study using Response Evaluation Criteria In Solid Tumors (RECIST) criteria.

Conditions

• Solid Tumor Malignancies, Cancer

Interventions

Type	Name	Description
DRUG	E7974	Maximum tolerated dose = 0.15 mg/m\^2 administered on Days 1, 8, 15 of 28-day cycle.
DRUG	E7974	Maximum tolerated dose = 0.37 mg/m\^2 administered on Days 1 and 8 of 21-day cycle.

Timeline

• Start date: 2005-07-01
• Primary completion: 2009-10-01
• Completion: 2009-10-01
• First posted: 2005-07-21
• Last updated: 2015-07-01

Locations

2 sites across 1 country: United States