53
Participants
Start Date
January 31, 2008
Primary Completion Date
August 31, 2012
Study Completion Date
March 31, 2013
Bortezomib
Escalating doses of bortezomib will be administered intravenously on Days 8, 11, 15 and 18 of a 28-day cycle (Schedule A) or of a 21-day cycle (Schedule B). The planned doses to be evaluated are 0.7, 1 and 1.3 mg/m2 in combination with PD 0332991 and dexamethasone.
Dexamethasone
20 mg, orally on Days 8, 11, 15 and 18 of a 28 day cycle (Schedule A) or of a 21-day cycle (Schedule B) in combination with PD 0332991 and bortezomib.
PD 0332991
Escalating doses of PD 0332991 will be administered orally on Days 1-21 of a 28-day cycle for Schedule A and on Days 1-12 of a 21-day cycle for Schedule B. The planned doses to be evaluated are 50, 75, 100 mg and 125 mg once daily in combination with bortezomib and dexamethasone.
New York Presbyterian, Weill Cornell Medical College, New York
Vseobecna fakultni nemocnice v Praze, Prague
Roswell Park Cancer Institute, Buffalo
University of Pittsburgh Cancer Institute, Pittsburgh
University of Pennsylvania Abramson Cancer Center, Philadelphia
University of Maryland, Baltimore
Hollings Cancer Center, Charleston
Medical University of South Carolina, Charleston
Karmanos Cancer Institute, Detroit
Klinikum Johannes-Gutenberg -Universitaet, III. Medizinische Klinik und Poliklinik, Mainz
Northwestern Medical Faculty Foundation, Chicago
Northwestern Memorial Hospital/Main Labs, Chicago
Barnes-Jewish Hospital, St Louis
Washington University School of Medicine, St Louis
University of Kansas Medical Center, Kansas City
University of Kansas Cancer Center and Medical Pavilion, Westwood
Nebraska Methodist Hospital, Omaha
Universitaetsklinikum Heidelberg, Heidelberg
Washington University School of Medicine, St Louis
Lead Sponsor
Pfizer
INDUSTRY