A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study
The goal of this clinical research study is to learn if PCI-32765 (also known as ibrutinib or IMBRUVICA) continues to be safe and effective when given long-term (beyond your previous ibrutinib treatment) to treat lymphoma. Participants in this study took part in a previous ibrutinib study and are benefitting from treatment. Ibrutinib is designed to block a protein that may cause cancer cells to grow.
Disease Group: Lymphoma
Treatment Agent: PCI-32765
Treatment Location: Both at MDACC & and Other Sites
Sponsor: Janssen Research & Development, LLC
The objective of Study PCI-32765CAN3001 (hereafter referred to as CAN3001) is to collect long-term safety and efficacy data for subjects treated with PCI-32765 and to provide ongoing access to PCI-32765 for subjects who are currently enrolled in PCI-32765 studies that have been completed according to the parent protocol (eg, final analysis has been performed), are actively receiving treatment with PCI-32765, and who continue to benefit from PCI-32765 treatment.
IRB Review and Approval Date: 08/29/2013
Recruitment Status: Open
Projected Accrual: 700
1) Criterion modified per Amendment INT-4: Subjects must be currently
participating in a PCI-32765 clinical study considered complete and have
received at least 6 months of treatment with PCI-32765. At study entry,
subjects 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
2) Investigator’s assessment that the benefit of continued PCI-32765 therapy will outweigh the risks.
3) Women of childbearing potential and men who are sexually active with a woman of childbearing potential must be practicing a highly effective method of birth control during and after the study (1 month after the last dose of PCI-32765 for women and 3 months after the last dose of PCI-32765 for men), consistent with local regulations regarding the use of birth control methods for subjects participating in clinical studies. Men must agree to not donate sperm during and for 3 months after receiving the last dose of PCI-32765.
4) Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) or urine pregnancy test at Screening.
5) Sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
1) Subjects who require anticoagulation with warfarin or equivalent
vitamin K antagonists (eg, phenprocoumon).
2) Subjects who require treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors, unless previously approved by sponsor.
3) Any condition or situation which, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with subject’s participation in the study.
Information and next steps
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