A Long-term Extension Study of PCI-32765 (Ibrutinib) (CAN3001)

November 2, 2026 updated by: Janssen Research & Development, LLC

PCI-32765CAN3001: A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open-label (identity of assigned study drug will be known) study designed to collect long-term safety and efficacy data and provide ibrutinib access to participants in completed ibrutinib studies. PCI-32765 (Ibrutinib) 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, "ibrutinib" will be used. Participants will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study until the investigator determines that the participant is no longer benefitting from treatment (ie, disease progression or unacceptable toxicity has occurred), the participant withdraws consent, alternative access to ibrutinib is available and feasible (example, participant assistance program or commercial source of ibrutinib), or for other reasons as defined in the protocol, or until the end of the study, whichever occurs earlier. Safety will be monitored throughout the study and summarized. Efficacy may be analyzed in combination with the data collected in the parent protocol. There is no formal hypothesis testing planned for this long-term extension study. Participants for whom alternative access to ibrutinib is not available and feasible can receive treatment with single-agent ibrutinib until end of study, which is defined as the time when all participants still receiving study treatment have transitioned to commercial or alternative access to ibrutinib, have stopped receiving ibrutinib treatment, or upon a decision by the sponsor to terminate the study, whichever occurs earlier.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
539

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Autonoma Buenos Aires, Argentina
      • Ciudad de Buenos Aires, Argentina
  • Australia
      • Adelaide, Australia
      • Coburg, Australia
      • Concord, Australia
      • Heidelberg, Australia
      • Melbourne, Australia
      • Perth, Australia
      • Prahran, Australia
      • Wahroonga, Australia
  • Belgium
      • Antwerp, Belgium
      • Bruges, Belgium
      • Brussels, Belgium
      • Ghent, Belgium
      • Leuven, Belgium
      • Yvoir, Belgium
  • Brazil
      • Rio de Janeiro, Brazil
      • Salvador, Brazil
      • São Paulo, Brazil
  • Canada
    • Quebec
      • Montreal, Quebec, Canada
  • China
      • Beijing, China
      • Chengdu, China
      • Fuzhou, China
      • Guangzhou, China
      • Hangzhou, China
      • Shanghai, China
      • Shanxi, China
      • Suzhou, China
      • Tianjin, China
      • Wuhan, China
  • Colombia
      • Bogotá, Colombia
      • Floridablanca, Colombia
  • Czechia
      • Brno, Czechia
      • Prague, Czechia
  • France
      • Créteil, France
      • Mulhouse, France
      • Paris, France
      • Pessac, France
      • Pierre-Bénite, France
      • Tours, France
  • Germany
      • Berlin, Germany
      • Dresden, Germany
      • Essen, Germany
      • Giessen, Germany
      • Heidelberg, Germany
      • Homburg/Saar, Germany
      • Magdeburg, Germany
      • Marburg, Germany
      • Ulm, Germany
  • Greece
      • Athens, Greece
      • Thessalonikis, Greece
  • Hungary
      • Budapest, Hungary
      • Szeged, Hungary
  • Ireland
      • Dublin, Ireland
  • Israel
      • Afula, Israel
      • Hadera, Israel
      • Haifa, Israel
      • Petah Tikva, Israel
      • Ramat Gan, Israel
      • Tel Aviv, Israel
  • Japan
      • Bunkyō City, Japan
      • Hiroshima, Japan
  • Mexico
      • Oaxaca City, Mexico
  • Netherlands
      • Amsterdam, Netherlands
  • Poland
      • Brzozów, Poland
      • Chorzów, Poland
      • Gdansk, Poland
      • Klinika Nowotworow Ukladu Chlonnego, Poland
      • Krakow, Poland
      • Opole, Poland
      • Słupsk, Poland
      • Wroclaw, Poland
  • Portugal
      • Lisbon, Portugal
      • Porto, Portugal
  • Puerto Rico
      • San Juan, Puerto Rico
  • Russia
      • Arkhangelsk, Russia
      • Chelyabinsk, Russia
      • Dzerzhinsk, Russia
      • Moscow, Russia
      • Nizhny Novgorod, Russia
      • Obninsk, Russia
      • Perm, Russia
      • Petrozavodsk, Russia
      • Rostov-on-Don, Russia
      • Ryazan, Russia
      • Saint, Russia
      • Saint Petersburg, Russia
      • Samara, Russia
      • Sochi, Russia
      • Syktyvkar, Russia
  • South Korea
      • Goyang-si, South Korea
      • Seoul, South Korea
  • Spain
      • Barcelona, Spain
      • L'Hospitalet de Llobregat, Spain
      • Madrid, Spain
      • Pamplona, Spain
      • Salamanca, Spain
  • Sweden
      • Gothenburg, Sweden
      • Lund, Sweden
      • Stockholm, Sweden
  • Taiwan
      • Changhua County, Taiwan
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
      • Izmir, Turkey (Türkiye)
      • Kayseri, Turkey (Türkiye)
  • Ukraine
      • Cherkasy, Ukraine
      • Dnipro, Ukraine
      • Kharkiv, Ukraine
      • Khmelnitskiy, Ukraine
      • Kiev, Ukraine
      • Lviv, Ukraine
      • Vinnitsa, Ukraine
  • United Kingdom
      • Birmingham, United Kingdom
      • Bournemouth, United Kingdom
      • Colchester, United Kingdom
      • Glasgow, United Kingdom
      • Leeds, United Kingdom
      • Leicester, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Newcastle upon Tyne, United Kingdom
      • Nottingham, United Kingdom
      • Plymouth, United Kingdom
      • Sheffield, United Kingdom
      • Southampton, United Kingdom
      • Sutton, United Kingdom
  • United States
    • California
      • Duarte, California, United States
      • La Jolla, California, United States
      • Los Angeles, California, United States
      • Orange, California, United States
      • Stanford, California, United States
    • Connecticut
      • Norwalk, Connecticut, United States
    • Georgia
      • Marietta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Goshen, Indiana, United States
    • Kansas
      • Westwood, Kansas, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Battle Creek, Michigan, United States
      • Detroit, Michigan, United States
    • Missouri
      • St Louis, Missouri, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • New Jersey
      • Hackensack, New Jersey, United States
    • New York
      • New York, New York, United States
    • North Carolina
      • Goldsboro, North Carolina, United States
    • Ohio
      • Columbus, Ohio, United States
    • Oregon
      • Eugene, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • South Dakota
      • Sioux Falls, South Dakota, United States
    • Texas
      • Houston, Texas, United States
    • Virginia
      • Charlottesville, Virginia, United States
    • Washington
      • Seattle, Washington, United States
    • West Virginia
      • Morgantown, West Virginia, United States
    • Wisconsin
      • Madison, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ibrutinib
Drug: Ibrutinib

Ibrutinib will be given orally as capsules, once daily continuously, according to the current dosing regimen established in the parent ibrutinib clinical study (560 mg, 420 mg, 280 mg, or 140 mg), at approximately the same time each day.

Other Names:
  • PCI-32765

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of participants affected by an adverse event
Time Frame: Up to 30 days after the last dose of study drug, or until the start of a subsequent systemic anti-cancer therapy, if earlier
Up to 30 days after the last dose of study drug, or until the start of a subsequent systemic anti-cancer therapy, if earlier

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Number of participants with change in disease status
Time Frame: Up to the end-of-treatment visit (up to 30 days after the last dose of study medication), or until the start of a subsequent anti-caner therapy, if earlier
Up to the end-of-treatment visit (up to 30 days after the last dose of study medication), or until the start of a subsequent anti-caner therapy, if earlier

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pharmacyclics LLC.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 9, 2013

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR100955
  • 2012-004225-24 (EudraCT Number)
  • PCI-32765CAN3001 (Other Identifier: Janssen Research & Development, LLC)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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