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| Sponsor: | Eisai Inc. |
|---|---|
| Information provided by: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00060567 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: E7070 + irinotecan combination Drug: Irinotecan + E7070 combination |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase I Dose-Finding Study of E7070 in Combination With Irinotecan |
| Estimated Enrollment: | 80 |
| Study Start Date: | March 2003 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Active combination of E7070 and irinotecan.
|
Drug: E7070 + irinotecan combination
Escalating doses starting from 125 mg/m2 irinotecan plus 250 mg/m2 E7070 combination.
|
|
2
Active combination of E7070 and irinotecan.
|
Drug: Irinotecan + E7070 combination
Escalating doses starting from 100 mg/m2 irinotecan plus 400 mg/m2 E7070 combination.
|
|
3
Active combination of E7070 and irinotecan.
|
Drug: Irinotecan + E7070 combination
Escalating doses starting from 100 mg/m2 irinotecan plus 400 mg/m2 E7070 combination.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients must meet the following screening hematologic values:
Patients must meet the following screening values for liver function:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | Eisai Medical Services, Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT00060567 History of Changes |
| Other Study ID Numbers: | E7070-A001-106 |
| Study First Received: | May 7, 2003 |
| Last Updated: | October 30, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
E7070 Irinotecan hydrochloride gastrointestinal cancer |
|
Irinotecan Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents |
Physiological Effects of Drugs Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |