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

Trial Status: Enrolling by Invitation

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.

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

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Palo Alto
Stanford Cancer Institute Palo Alto
Status: CLOSED_TO_ACCRUAL
San Diego
University of California San Diego
Status: CLOSED_TO_ACCRUAL

Illinois

Chicago
Northwestern University
Status: CLOSED_TO_ACCRUAL

Kansas

Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE

Massachusetts

Boston
Brigham and Women's Hospital
Status: CLOSED_TO_ACCRUAL
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL

Michigan

Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL
Detroit
Wayne State University / Karmanos Cancer Institute
Status: CLOSED_TO_ACCRUAL
Contact: Jay Yang
Phone: 313-576-8952

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: CLOSED_TO_ACCRUAL

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: CLOSED_TO_ACCRUAL

New York

New York
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Virginia

Charlottesville
University of Virginia Cancer Center
Status: CLOSED_TO_ACCRUAL

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: CLOSED_TO_ACCRUAL

Wisconsin

Madison
University of Wisconsin Hospital and Clinics
Status: CLOSED_TO_ACCRUAL

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 Phase Phase III

Trial Type Treatment

Lead Organization
Janssen Research & Development, LLC

  • Primary ID CR100955
  • Secondary IDs NCI-2013-02262, 2012-004225-24, PCI-32765CAN3001
  • Clinicaltrials.gov ID NCT01804686