drugset / Trial / NCT00165594

A Study of E7070 in Patients With Gastric Cancer

NCT00165594

Phase 1/2 Terminated 50 enrolled Eisai Inc.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Phase I study: To investigate primary objective (maximal tolerated dose and dose-limiting toxicity) and secondary objectives (pharmacokinetics, safety, estimation of a recommended dose, and anti-tumor effect by evaluable case) of E7070 in patients with gastric cancer who are extensive or intermediate metabolizer type (EM/IM) to CYP2C9 and CYP2C9 by intravenously administering once every 3 weeks. Phase IIa study: To investigate primary objective (response rate for efficacy assessment) and secondary objectives (frequency and severity of adverse drug reactions, and pharmacokinetics) of E7070 in patient with gastric cancer who are EM/IM type by intravenously administering once every 3 weeks.

Timeline

Start
2005-02
Primary completion
2006-07
Completion
2006-08

Drugs

EvaluationDrugModalityDoseRoute
Subject indisulam Small molecule Intravenous

Indications