drugset / Trial / NCT00499499

A Dose Escalation Study of E7107 Administered Intravenously on Days 1 and 8 Every 21 Days to Patients With Solid Tumors

NCT00499499 ↗

Phase 1 Suspended 40 enrolled Eisai Inc.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to investigate E7107 in patients with solid tumors. This is an open label, dose-escalation study of E7107. The maximum tolerated dose (MTD) of the single agent will be established by determining the occurrence of dose limiting toxicities during the first three weeks of therapy (Cycle 1). Patients in this study will be treated at multiple dose levels, starting at 0.6 mg/m\^2. Patients will receive E7107 as a 30-minute intravenous infusion on Days 1 and 8 every 21 Days.

Timeline

Start
2007-07
Primary completion
2009-06
Completion
2010-08

Drugs

EvaluationDrugModalityDoseRoute
Subject E7107 Small molecule 0.6 mg/m2 Intravenous
Subject E7107 Small molecule 1.2 mg/m2 Intravenous
Subject E7107 Small molecule 1.8 mg/m2 Intravenous
Subject E7107 Small molecule 2.4 mg/m2 Intravenous
Subject E7107 Small molecule 3.2 mg/m2 Intravenous
Subject E7107 Small molecule 4.3 mg/m2 Intravenous
Subject E7107 Small molecule 5.7 mg/m2 Intravenous

Indications