Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study

Details

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.

Keywords

Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Mantle Cell Lymphoma Follicular Lymphoma Diffuse Large B-cell Lymphoma PCI-32765 Ibrutinib Bruton's tyrosine kinase inhibitor IMBRUVICA JNJ-54179060 Lymphoma Lymphoma, Follicular Leukemia, Lymphoid Leukemia, Lymphocytic, Chronic, B-Cell Lymphoma, B-Cell Lymphoma, Mantle-Cell Lymphoma, Large B-Cell, Diffuse PCI-32765 (Ibrutinib)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California San Diego Medical Center
    La Jolla California 92093 United States
  • City of Hope Cancer Center
    Duarte California 91010 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Janssen Research & Development, LLC
ID
NCT01804686
Phase
Phase 3
Study Type
Interventional
Last Updated