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Sponsored by: |
Eisai Medical Research Inc. |
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Information provided by: | Eisai Medical Research Inc. |
ClinicalTrials.gov Identifier: | NCT00309179 |
This study proposes to determine the safety of the administration of E7820 plus cetuximab and explore the MTD of the combination in a Phase Ib study. In addition, the efficacy of this combination will be explored in patients with colorectal cancer in the Phase II proof of concept phase of the study.
Condition | Intervention | Phase |
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Advanced Colorectal Cancer |
Drug: E7820 plus cetuximab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
Official Title: | A Single Arm Phase II Study of the Efficacy, Safety, and Biomarkers of Activity of E7820 Plus Cetuximab in Advanced Solid Tumors Preceded by a Run-In Study to Determine Safety of the Combination |
Estimated Enrollment: | 99 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: E7820 plus cetuximab
Escalating doses from 40 mg/m^2 irinotecan plus E7820 in combination with cetuximab.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Eisai Medical Services | 1-888-422-4743 |
United States, California | |
University of Southern California | Recruiting |
Los Angeles, California, United States, 90089-9177 | |
United States, Florida | |
University of Miami | Recruiting |
Miami, Florida, United States, 33136 | |
Contact: Caio Max S. Rocha Lima, M.D. 305-243-1086 |
Study Director: | Daniel Rossignol, Ph.D. | Eisai Medical Research Inc. |
Responsible Party: | Eisai Medical Research Inc. ( Daniel Rossignol, Ph.D ) |
Study ID Numbers: | E7820-A001-204 |
Study First Received: | March 29, 2006 |
Last Updated: | July 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00309179 |
Health Authority: | United States: Food and Drug Administration |
Advanced colorectal cancer |
Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Cetuximab Irinotecan Colonic Diseases |
Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |