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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01804686
Recruitment Status : Enrolling by invitation
First Posted : March 5, 2013
Last Update Posted : October 18, 2019
Pharmacyclics LLC.
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Tracking Information
First Submitted Date  ICMJE March 4, 2013
First Posted Date  ICMJE March 5, 2013
Last Update Posted Date October 18, 2019
Actual Study Start Date  ICMJE September 9, 2013
Estimated Primary Completion Date December 29, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2013)
Number of participants affected by an adverse event [ Time Frame: Up to 30 days after the last dose of study medication ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01804686 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2013)
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) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Long-term Extension Study of PCI-32765 (Ibrutinib)
Official Title  ICMJE A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study
Brief Summary The purpose of this study is to collect long-term safety and efficacy data for participants treated with PCI-32765 (Ibrutinib) and to provide ongoing access to PCI-32765 for participants who are currently enrolled in PCI-32765 studies that have been completed according to the parent protocol, are actively receiving treatment with PCI-32765, and who continue to benefit from PCI-32765 treatment.
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 PCI-32765 (Ibrutinib) access to participants in completed PCI-32765 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, "PCI-32765"will be used. Participants will continue with the current PCI-32765 dosing regimen established in the parent PCI-32765 study until the investigator determines that the participant is no longer benefitting from treatment (ie, disease progression or unacceptable toxicity has occurred), the study is terminated by the sponsor, the participant withdraws consent, alternative access to PCI-32765 is available and feasible, or for other reasons as defined in the protocol. Safety will be monitored throughout the study and summarized. Efficacy may be analyzed in combination with the data collected in the parent protocol. Blood samples and a lymph node biopsy sample for biomarker evaluations will be collected at the time of disease progression or at the End of Treatment visit for participants who discontinue treatment without disease progression (where local regulations and shipping logistics permit). There is no formal hypothesis testing planned for this long-term extension study. Participants can receive treatment with single-agent PCI-32765 and continue until 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Mantle Cell Lymphoma
  • Follicular Lymphoma
  • Diffuse Large B-cell Lymphoma
Intervention  ICMJE Drug: PCI-32765 (Ibrutinib)
PCI-32765 (Ibrutinib) will be given orally as capsules, once daily continuously, according to the current dosing regimen established in the parent PCI-32765 clinical study (560 mg, 420 mg, 280 mg, or 140 mg), at approximately the same time each day.
Study Arms  ICMJE Experimental: PCI-32765 (Ibrutinib)
Intervention: Drug: PCI-32765 (Ibrutinib)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: May 19, 2016)
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2013)
Estimated Study Completion Date  ICMJE December 31, 2026
Estimated Primary Completion Date December 29, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 participants 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 participants with less than 6 months will be required to have more frequent initial safety assessments
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Brazil,   Canada,   China,   Colombia,   Czechia,   France,   Germany,   Greece,   Hungary,   Ireland,   Israel,   Italy,   Korea, Republic of,   Mexico,   Netherlands,   Poland,   Portugal,   Russian Federation,   Spain,   Sweden,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Czech Republic
Administrative Information
NCT Number  ICMJE NCT01804686
Other Study ID Numbers  ICMJE CR100955
2012-004225-24 ( EudraCT Number )
PCI-32765CAN3001 ( Other Identifier: Janssen Research & Development, LLC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Research & Development, LLC
Study Sponsor  ICMJE Janssen Research & Development, LLC
Collaborators  ICMJE Pharmacyclics LLC.
Investigators  ICMJE
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
PRS Account Janssen Research & Development, LLC
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP