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Sponsored by: |
Eisai Medical Research Inc. |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00060567 |
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 |
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Cancer |
Drug: E7070 + irinotecan combination Drug: Irinotecan + E7070 combination |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
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1
Active combination of E7070 and irinotecan.
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Drug: E7070 + irinotecan combination
Escalating doses starting from 125 mg/m2 irinotecan plus 250 mg/m2 E7070 combination.
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2
Active combination of E7070 and irinotecan.
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Drug: Irinotecan + E7070 combination
Escalating doses starting from 100 mg/m2 irinotecan plus 400 mg/m2 E7070 combination.
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3
Active combination of E7070 and irinotecan.
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Drug: Irinotecan + E7070 combination
Escalating doses starting from 100 mg/m2 irinotecan plus 400 mg/m2 E7070 combination.
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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:
Women who are pregnant or breastfeeding. Women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test.
Women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator (postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential),
United States, Massachusetts | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 |
Study Director: | Dan Rossignol, Ph.D | Eisai Medical Research Inc. |
Responsible Party: | Eisai Inc. ( Eisai Medical Services ) |
Study ID Numbers: | E7070-A001-106 |
Study First Received: | May 7, 2003 |
Last Updated: | June 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00060567 History of Changes |
Health Authority: | United States: Food and Drug Administration |
E7070 Irinotecan hydrochloride gastrointestinal cancer |
Signs and Symptoms Irinotecan Antineoplastic Agents, Phytogenic |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Irinotecan |
Enzyme Inhibitors Antineoplastic Agents, Phytogenic Pharmacologic Actions |