NCT00060567

Dose-Finding Study of E7070 in Combination With Irinotecan

Phase I Dose-Finding Study of E7070 in Combination With Irinotecan

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

E7070 and irinotecan will be administered to patients with GI tract, pancreatic or lung tumors on Days 1 and 8 of a 21-day cycle, or Days 1 and 15 of a 28-day cycle according to one of two E7070 dose escalation schemes.

Conditions

• Cancer

Interventions

Type	Name	Description
DRUG	E7070 + irinotecan combination	Escalating doses starting from 125 mg/m2 irinotecan plus 250 mg/m2 E7070 combination.
DRUG	Irinotecan + E7070 combination	Escalating doses starting from 100 mg/m2 irinotecan plus 400 mg/m2 E7070 combination.
DRUG	Irinotecan + E7070 combination	Escalating doses starting from 100 mg/m2 irinotecan plus 400 mg/m2 E7070 combination.

Timeline

• Start date: 2003-03-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2003-05-09
• Last updated: 2023-06-18

Locations

1 site across 1 country: United States