28
Participants
Start Date
September 30, 2011
Primary Completion Date
July 31, 2013
Study Completion Date
July 31, 2013
MSC2015103B
Schedule 1: MSC2015103B will be administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD establishment. Starting dose will be 150 microgram (mcg), which will be escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
MSC2015103B
Schedule 2: MSC2015103B will be administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose will be 150 mcg, and will be escalated to 200 mcg subsequently.
Beth Israel Deaconess Medical Center, Boston
Dana-Farber Cancer Institute, Boston
Karmanos Cancer Institute, Detroit
Lead Sponsor
EMD Serono
INDUSTRY