Lenalidomide and Cetuximab in Patients With Advanced Solid Tumors

"Lenalidomide will be supplied as 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration.~Prior to Cycle 1, there will be a 21 day lead in treatment period with lenalidomide monotherapy (Days -21 to -1). Combination treatment will start at Day 1. Subjects will be enrolled in cohorts of three to receive a single, oral dose of lenalidomide administered on Days 1-28. For each cohort of subjects, the decision of whether or not to dose-escalate will be made after subjects have received the first treatment cycle of study drug. Treatment will continue until the occurrence of any of the following events.~* Disease progression~* Adverse event(s) that, in the judgment of the Investigator, may cause severe or permanent harm or which rule out continuation of the treatment regimen.~* Major violation of the study protocol.~* Withdrawal of consent~* Lost to follow up~* Death~* Suspected pregnancy"

"Combination treatment will start at Day 1. Subjects meeting will be enrolled in cohorts of three to receive infusions of cetuximab (400 mg/m2 first infusion only, then 250 mg/m2 subsequently) administered on Days 1, 8, 15, and 22 of each 28-day cycle. Cetuximab will be supplied as Erbitux® 22 mg/ml Vial à 50 ml, Erbitux 5 mg/ml Vial à 10 ml and Erbitux 5 mg/ml Vial à 50 ml for intravenous administration.~Treatment will continue until the occurrence of any of the following events.~* Disease progression~* Adverse event(s) that, in the judgment of the Investigator, may cause severe or permanent harm or which rule out continuation of the treatment regimen.~* Major violation of the study protocol.~* Withdrawal of consent~* Lost to follow up~* Death~* Suspected pregnancy"