Clinical TrialsThe James Cancer Center Columbus, OH
open for enrollment
A Long-term Extension Study of PCI-32765 (Ibrutinib)
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.
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?
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
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