A Study to Evaluate the Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in Patients With Recurrent Mature B-Cell Neoplasms

PHASE1CompletedINTERVENTIONAL
Enrollment

15

Participants

Timeline

Start Date

September 12, 2012

Primary Completion Date

November 20, 2015

Study Completion Date

February 1, 2017

Conditions
Recurrent Mature B-cell Neoplasms
Interventions
DRUG

PCI-32765

PCI-32765 will be administered in Cohort 1, Cohort 2 and CLL/SLL Cohort. In Cohort 1, single oral dose of PCI-32765 140 mg and 280 mg will be administered before daily oral doses of 420 mg per day for 35 days in Cycle 1 and for 28 days in Cycle 2 and thereafter. In Cohort 2 and CLL/SLL Cohort, PCI-32765 560 mg and 420 mg per day, respectively will be administered daily for 35 days in Cycle 1 and for 28 days in Cycle 2 and thereafter.

Trial Locations (4)

Unknown

Kyoto

Nagoya

Sendai

Tokyo

Sponsors
All Listed Sponsors
collaborator

Pharmacyclics LLC.

INDUSTRY

lead

Janssen Pharmaceutical K.K.

INDUSTRY