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A Long-term Extension Study of PCI-32765 (Ibrutinib)
Not Recruiting
Trial ID: NCT01804686,,
Purpose
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.
Official Title
A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study
Eligibility
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
Intervention(s):
drug: Ibrutinib
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sucharita Mitra Chatterjee
650-723-2271