9
Participants
Start Date
May 31, 2008
Primary Completion Date
April 30, 2009
Study Completion Date
April 30, 2009
GCS-100
GCS-100 160mg/m2 IV (in the vein) on Study Days 1, 4, 8 and 11 for up to 12 consecutive 21-day treatment cycles. Three patients will be assigned to each cohort until maximum tolerated dose is reached. The dose levels: 1) 160 mg/m2; 2) 210 mg/m2; 3) 280 mg/m2; 4) 370 mg/m2
Bortezomib/Dexamethasone
Bortezomid 1.3 mg/m2 and dexamethasone 20 mg/day plus an additional 20 mg of dexamethasone on the day following each of the GCS-100/bortezomib and dexamethasone dosing. GCS-100/bortezomib and dexamethasone dosed on Study Days 1, 4, 8 and 11 of each 21-day cycle after disease progression is noted.
University of Florida, Gainesville
Froedtert & Medical College Clinics, Medical College of Wisconsin, Milwaukee
Dana Farber Cancer Institute, Boston
Lead Sponsor
La Jolla Pharmaceutical Company
INDUSTRY