ClinicaliQ Trial Snapshot
- A Long-term Extension Study of PCI-32765 (Ibrutinib) — Recruiting • Phase III • Oncology • NCT01804686.
- What is being tested: Long-term safety and efficacy of ibrutinib (PCI-32765), a Bruton's tyrosine kinase (BTK) inhibitor, in patients who have completed primary ibrutinib trial protocols and are benefiting from continued treatment.
- Patient eligibility overview: Participants currently enrolled in completed ibrutinib clinical studies who continue to demonstrate clinical benefit and have no safety concerns that would contraindicate ongoing therapy, providing continued access to the drug outside standard treatment pathways.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
- : * 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.