45
Participants
Start Date
March 31, 2009
Primary Completion Date
September 30, 2012
Study Completion Date
December 31, 2012
RAD001 in combination with sorafenib
"Phase I / Dose escalation: during the first cycle RAD001 (2.5-10 mg/day) will be administered alone, once a day, on days 1-14 to allow PK-profiling of the drug. From day 15 sorafenib administration (400-800 mg/day) twice a day will be added.~The cycle 1 will last 6 weeks, subsequent cycles will last 4 weeks (the 2 drugs administered in combination from day 1 to day 28).~Phase II: The drugs will be administered at the Recommended Dose and each treatment cycle will last 4 weeks."
Istituto Europeo di Oncologia,, Milan