The objective of this study 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…
ID
Source
Brief title
Condition
- Lymphomas non-Hodgkin's B-cell
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The objective of this study 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.
Secondary outcome
not applicable
Background summary
A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension
Study
PCI-32765 (IMBRUVICA*; ibrutinib; JNJ-54179060) 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, *PCI-32765* will be used. PCI-32765 is being investigated for the
treatment of subjects with chronic lymphocytic leukemia/small lymphocytic
lymphoma, mantle cell lymphoma, follicular lymphoma, and diffuse large B-cell
lymphoma. PCI-32765 is being co-developed by Janssen Research & Development,
LLC and Pharmacyclics, Inc. Ibrutinib was approved by the United States Food
and Drug Administration for the treatment of adult patients with mantle cell
lymphoma and chronic lymphocytic leukemia who have received at least one prior
therapy on 13 November 2013 and 12 February 2014, respectively. Approvals have
also been obtained in a number of other countries worldwide. For the most
comprehensive nonclinical and clinical information regarding the efficacy and
safety of PCI-32765, refer to the latest version of the Investigator's
Brochure.
Study objective
The objective of this study 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.
Study design
This Phase 3b, multicenter, open-label study will collect long-term safety and
efficacy data and provide PCI-32765 access to subjects in completed PCI-32765
studies. Subjects will continue with the current PCI-32765 dosing regimen
established in the parent PCI-32765 study until the investigator determines
that the subject is no longer benefitting from treatment (ie, disease
progression or unacceptable toxicity has occurred), the study is terminated by
the sponsor, the subject withdraws consent, alternative access to PCI-32765 is
available and feasible, or for other reasons as defined in this protocol.
Subjects can receive treatment with single-agent PCI-32765 until the end of
study, which is defined as the time of the last End-of-Treatment safety
assessment for the last subject participating in the study or 5 years after the
last subject entered, or upon a decision by the sponsor to terminate the study,
whichever occurs earlier.
Intervention
Ibrutinib (oral, once daily) based on the treatment scheme in the parent
protocol.
Study burden and risks
not applicable
Dr. Paul Janssenweg 150
Tilburg 5026 RH
NL
Dr. Paul Janssenweg 150
Tilburg 5026 RH
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-004225-24-NL |
| ClinicalTrials.gov | NCT01804686 |
| CCMO | NL58351.056.16 |