NCT01109069 · FLOW

Participant flow

Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia · Source last updated 2020-05-27

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

description
A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia. This is a multicenter(16 sites in the USA), open-label, monotherapy, long-term extension study designed to evaluate the long-term (\> 6 months) safety and tolerability of a fixed daily dosing regimen of ibrutinib. Ibrutinib was supplied as 140 mg or 40 mg capsules for oral administration. Subjects were to receive daily administration of a fixed dose of ibrutinib at the same dose level as in the parent study (up to 840 mg).
id
FG000
title
A LONG-TERM SAFETY STUDY OF BRUTON'S TYROSINE KINASE (BTK) INH

periods

milestones
achievements
group Id
FG000
num Subjects
199
type
STARTED
achievements
group Id
FG000
num Subjects
106
type
COMPLETED
achievements
group Id
FG000
num Subjects
93
type
NOT COMPLETED
title
Overall Study

pre Assignment Details

This study was open to subjects from prior ibrutinib studies who met eligibility criteria for rollover from their parent study and wanted to continue receiving study drug.

recruitment Details

27 July 2010 (the first Patient enrolled) to 31 March 2016 (the Last patient enrolled), Study was approved on June 2010.

Complete source fields