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

Summary

Participation Requirements

Description

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, covalent...

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.

Tracking Information