NL-OMON43124CompletedPhase 3
A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study - CAN3001
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Janssen-Cilag
- Enrollment
- 1
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 64 (—)
Inclusion Criteria
- •- 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;- Subjects 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 subjects with less than 6 months will be required to have more frequent initial safety assessments (see Time and Events Table 2);- 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
Investigators
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