Clinical Trials /

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

NCT01804686

Description:

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.

Related Conditions:
  • Chronic Lymphocytic Leukemia
  • Diffuse Large B-Cell Lymphoma
  • Follicular Lymphoma
  • Mantle Cell Lymphoma
  • Small Lymphocytic Lymphoma
  • Waldenstrom Macroglobulinemia
Recruiting Status:

Enrolling by invitation

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Long-term Extension Study of PCI-32765 (Ibrutinib)
  • Official Title: A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study

Clinical Trial IDs

  • ORG STUDY ID: CR100955
  • SECONDARY ID: 2012-004225-24
  • SECONDARY ID: PCI-32765CAN3001
  • NCT ID: NCT01804686

Conditions

  • Chronic Lymphocytic Leukemia
  • Small Lymphocytic Lymphoma
  • Mantle Cell Lymphoma
  • Follicular Lymphoma
  • Diffuse Large B-cell Lymphoma
  • Waldenstrom Macroglobulinemia
  • Chronic Graft Versus Host Disease

Interventions

DrugSynonymsArms
PCI-32765 (Ibrutinib)PCI-32765 (Ibrutinib)

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
PCI-32765 (Ibrutinib)Experimental
  • PCI-32765 (Ibrutinib)

Eligibility Criteria

        Inclusion Criteria:

          -  Participants 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, 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

          -  Investigator's assessment that the benefit of continued PCI-32765 therapy 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Secondary Outcome Measures

Measure: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
Safety Issue:
Description:

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Janssen Research & Development, LLC

Trial Keywords

  • Chronic lymphocytic leukemia
  • Small lymphocytic lymphoma
  • Mantle cell lymphoma
  • Follicular lymphoma
  • Diffuse large B-cell lymphoma
  • PCI-32765
  • Ibrutinib
  • Bruton's tyrosine kinase inhibitor
  • IMBRUVICA
  • JNJ-54179060

Last Updated

January 17, 2020