Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

A Long-term Extension Study of PCI-32765 (Ibrutinib)

Protocol: OSU-12224

Full Title

A Phase IIIb, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study


The purpose of this study is to collect long-term safety and efficacy data for participants

treated with PCI-32765 (Ibrutinib) and to provide ongoing access to PCI-32765 for

participants who are currently enrolled in PCI-32765 studies that have been completed

according to the parent protocol, are actively receiving treatment with PCI-32765, and who

continue to benefit from PCI-32765 treatment.

Study Objective

This is an open-label (identity of assigned study drug will be known) study designed to

collect long-term safety and efficacy data and provide PCI-32765 (Ibrutinib) access to

participants in completed PCI-32765 studies. PCI-32765 (Ibrutinib) is a first-in-class,

potent, orally-administered, covalently-binding small molecule inhibitor of bruton's

tyrosine kinase. "PCI-32765" and "ibrutinib" refer to the same molecule; hereafter,

"PCI-32765"will be used. Participants will continue with the current PCI-32765 dosing

regimen established in the parent PCI-32765 study until the investigator determines that the

participant is no longer benefitting from treatment (ie, disease progression or unacceptable

toxicity has occurred), the study is terminated by the sponsor, the participant withdraws

consent, alternative access to PCI-32765 is available and feasible, or for other reasons as

defined in the protocol. Safety will be monitored throughout the study and summarized.

Efficacy may be analyzed in combination with the data collected in the parent protocol.

Blood samples and a lymph node biopsy sample for biomarker evaluations will be collected at

the time of disease progression or at the End of Treatment visit for participants who

discontinue treatment without disease progression (where local regulations and shipping

logistics permit). There is no formal hypothesis testing planned for this long-term

extension study. Participants can receive treatment with single-agent PCI-32765 and continue

until end of study, which is defined as the time of the last End-of-Treatment safety

assessment for the last subject participating in the study or 5 years after the last subject

entered, or upon a decision by the sponsor to terminate the study, whichever occurs earlier.

Are you eligible?

Inclusion Criteria:

Participants must be currently participating in a PCI-32765 clinical study considered

completed and have received at least 6 months of treatment with PCI-32765.

At study entry, participants must be actively receiving treatment with single-agent

PCI-32765 or participants must have participated in a PCI-32765 randomized clinical

study in which they initially received comparator treatment and now cross-over to

ibrutinib. Note: A minimum of 6 months requirement for prior PCI-32765 treatment will

not be mandatory in this case and participants with less than 6 months will be

required to have more frequent initial safety assessments

Agrees to protocol-defined use of effective contraception

Negative blood or urine pregnancy test at screening

Exclusion Criteria:

Requires anticoagulation with warfarin or equivalent vitamin K antagonists

Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors, unless

previously approved by sponsor

Any condition or situation which, in the opinion of the investigator, may put the

participant at significant risk, may confound the study results, or may interfere

significantly with volunteer's participation in the study

Colon Cancer Rectal Cancer Gastrointestinal Cancers