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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Escalating doses from 40 mg/m\^2 irinotecan plus E7820 in combination with cetuximab.
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Edmonton, Alberta, Canada
Objective tumor response (CR or PR) and disease control (CR, PR or SD) rates will be evaluated in this study based on RECIST criteria and modified WHO criteria.
Time frame: The timing will be based on RECIST criteria and modified WHO criteria.
Pharmacokinetics: Blood samples will be taken on Days 1, 2, and 15 during Cycle 1 and Day 1. Pharmacodynamics: Blood will be taken prior to dosing on Day 1, Days 1, 2, and 15 during Cycle 1 and Day 1.
Time frame: Days 1, 2, and 15 during Cycle 1 and Day 1.
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