A Long-term Extension Study of PCI-32765 (Ibrutinib)
Sponsor: Janssen Research & Development, LLC
ClinicalTrials ID:NCT01804686
This open-label study collects long-term safety and efficacy data for ibrutinib, providing ongoing access for eligible participants from completed studies. Participants must have received at least 6 months of ibrutinib or be in specific ongoing studies. Ibrutinib is administered orally, daily, at established doses. Safety is monitored, and efficacy data may be combined with parent study results.
Patient Parameters
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Program Overview
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.
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 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.
Eligibility Criteria
Inclusion Criteria
- Participants must be currently participating in an ibrutinib clinical study considered complete and have received at least 6 months of treatment with ibrutinib. At study entry, participants must be actively receiving treatment with single-agent ibrutinib; or participants must have participated in an ibrutinib 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 ibrutinib 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; or participants must be currently participating in study PCI-32765LYM1002. At study entry, participants must be actively receiving combination treatment with ibrutinib and nivolumab or single-agent ibrutinib
- Investigator's assessment that the benefit of continued ibrutinib therapy as a single agent or in combination with nivolumab will outweigh the risks
- 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
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Cancer Center | 91010 | Duarte | California |
| University of California San Diego Medical Center | 92093 | La Jolla | California |
| University of California Los Angeles | 90095 | Los Angeles | California |
| St. Joseph Hospital Center for Cancer Prevention and Treatment | 92868 | Orange | California |
| Stanford University Medical Center | 94305 | Stanford | California |
| Stanford University | 94305 | Stanford | California |
| Norwalk Medical Group | 06850 | Norwalk | Connecticut |
| Northwest Georgia Oncology Centers PC | 30060 | Marietta | Georgia |
| Northwestern University Hospital | 60611 | Chicago | Illinois |
| Indiana University | 46526 | Goshen | Indiana |
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