Solid Tumor Clinical Trial
Official title:
A Phase I Study With Expansion Cohorts to Assess the Safety, Tolerability, and Activity of Eribulin ORA in Subjects With Solid Tumors
This is a nonrandomized, open-label, dosed escalation, safety activity, and PK study to determine the MTD and optimal dosing regimen of Eribulin ORA.
This is a multicenter, open-label safety, tolerability, pharmacokinetic, and activity study. Eligible subjects will be adults with advanced solid tumors. Groups of 3 to 6 subjects will receive a single dose of Eribulin ORA on Day 1 and Day 8 of a 21 day cycle and will be followed for toxicity. If non linearity in PK is observed, additional subjects will be added with study drug administered on Day 1 and 8 once every three weeks cycle. Subjects who tolerate the study drug and have stable disease or better response will be eligible to receive ongoing treatment. ;
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