Dose-Finding Study of E7070 in Combination With Irinotecan
NCT00060567 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 88
Last updated 2023-06-18
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
Interventions
- 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.
Sponsors & Collaborators
-
Eisai Inc.
lead INDUSTRY
Principal Investigators
-
Eisai Medical Services · Eisai Inc.
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-03-31
- Primary Completion
- 2013-03-31
- Completion
- 2013-03-31
Countries
- United States
Study Locations
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