PCI-32765CAN3001: A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study
PCI-32765CAN3001: A Phase 3b, 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 ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib 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 ibrutinib access to participants in completed ibrutinib 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, "ibrutinib" will be used. Participants will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study until the investigator determines that the participant is no longer benefitting from treatment (ie, disease progression or unacceptable toxicity has occurred), the participant withdraws consent, alternative access to ibrutinib is available and feasible (example, participant assistance program or commercial source of ibrutinib), or for other reasons as defined in the protocol, or until the end of the study, whichever occurs earlier. Safety will be monitored throughout the study and summarized. Efficacy may be analyzed in combination with the data collected in the parent protocol. There is no formal hypothesis testing planned for this long-term extension study. Participants for whom alternative access to ibrutinib is not available and feasible can receive treatment with single-agent ibrutinib until end of study, which is defined as the time when all participants still receiving study treatment have transitioned to commercial or alternative access to ibrutinib, have stopped receiving ibrutinib treatment, or upon a decision by the sponsor to terminate the study, whichever occurs earlier.
Inclusion Criteria:
Exclusion Criteria:
Participate-In-This-Study1@its.jnj.com
Orange, California 92868, United States
Louisville, Kentucky 40207, United States
Madison, Wisconsin 53705, United States
Ciudad Autonoma Buenos Aires, C1431, Argentina
Ciudad de Buenos Aires, C1114AAP, Argentina
Wahroonga, 2076, Australia
Prague, 100 34, Czechia
Prague, 128 08, Czechia
Berlin, 13589, Germany
Dresden, 01307, Germany
Homburg/Saar, 66424, Germany
Magdeburg, 39104, Germany
Ulm, 89081, Germany
Thessalonikis, 570 10, Greece
Roma, 00161, Italy
Bunkyō City, 113 8677, Japan
Brzozów, 36-200, Poland
Chorzów, 41-500, Poland
Klinika Nowotworow Ukladu Chlonnego, 02 781, Poland
Wroclaw, 50 367, Poland
Saint Petersburg, 193024, Russia
Saint, 194291, Russia
Stockholm, 171 76, Sweden
Changhua County, 500, Taiwan
Cherkasy, 18009, Ukraine
Kharkiv, 61024, Ukraine
Khmelnitskiy, 29000, Ukraine
Kiev, 03115, Ukraine
Lviv, 79044, Ukraine
Newcastle upon Tyne, NE7 7DN, United Kingdom