Study of the Safety and Tolerability of PCI-32765 in Patients With Recurrent B Cell Lymphoma

PHASE1CompletedINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

February 28, 2009

Primary Completion Date

July 31, 2012

Study Completion Date

July 31, 2012

Conditions
B-Cell LymphomaB-Cell Leukemia
Interventions
DRUG

PCI-32765

"In the dose-escalation cohorts, PCI-32765 will be administered in 1.25, 2.5, 5.0, 8.3, 12.5, and 17.5 mg/kg/d dose orally once per day for 28 days followed by a 7-day rest period to determine the MTD. If MTD is not reached, dosing levels may be increased beyond 17.5mg/kg/d by 33% increments.~In the continuous dosing cohorts, PCI-32765 will be administered in 8.3 mg/kg/day and 560 mg/day (fixed dose) dose orally once per day for 35 days."

Trial Locations (9)

10065

New York Prebyterian Hospital Cornell Medical Center, New York

60637

University of Chicago, Chicago

77030

University of Texas, MD Anderson, Houston

94305

Stanford University School of Medicine, Palo Alto

97401

Willamette Valley Cancer Institute/Research Ctr, Eugene

98684

Northwest Cancer Specialists, Vancouver Cancer Center, Vancouver

98902

Yakima Valley Memorial Hospital/North Star Lodge Cancer Ctr, Yakima

20892-1203

National Cancer Institute, Bethesda

05405

University of Vermont College of Medicine, Burlington

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pharmacyclics LLC.

INDUSTRY