NCT00849654

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

Phase I Dose-Escalation Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in Recurrent B Cell Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Pharmacyclics LLC. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to establish the safety and optimal dose of orally administered PCI-32765 in patients with recurrent B cell lymphoma.

Conditions

• B-Cell Lymphoma
• B-Cell Leukemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-02-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2009-02-24
• Last updated: 2013-05-22

Locations

9 sites across 1 country: United States