55
Participants
Start Date
July 31, 2008
Primary Completion Date
November 30, 2012
PCI-24781
"Phase I Dose Escalation: Up to 5 cohorts will receive PCI-24781 orally at doses starting at 30mg/m2 two times a day approximately 4-6 hours apart (BID), up to 90mg/m2 administered 5 days/week during the first 21 days of each 28 day cycle until the maximum tolerated dose (MTD) is reached. If a dose limiting toxicity (DLT) occurs, then the next cohort will receive PCI-24781 BID for 7 days every other week (2 times in a 28 day cycle).~Phase II Efficacy Evaluation: All patients will receive PCI-24781 orally at the dosage and regimen determined in Phase I."
Horizon Oncology Center, Lafayette
Northwestern University Medical School, Chicago
Washington University School of Medicine, St Louis
Nebraska Methodist Hospital, Omaha
University of Nebraska Medical Center, Omaha
University of California, San Francisco, San Francisco
University of Massachusetts Medical School, Worcester
University of Vermont and Fletcher Allen Health Care, Burlington
Lead Sponsor
Pharmacyclics LLC.
INDUSTRY