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



Status:Enrolling by invitation
Conditions:Blood Cancer, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:September 9, 2013
End Date:December 31, 2026

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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 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.

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.

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
We found this trial at
30
sites
300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
Stanford Univ Med Ctr The Medical Center is uniquely advantaged by its location on the...
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Los Angeles, California 90095
310-825-4321
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Battle Creek, Michigan 49016
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Boston, Massachusetts 02115
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Charlottesville, Virginia 22903
(434) 924-0311
University of Virginia The University of Virginia is distinctive among institutions of higher education. Founded...
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Chicago, Illinois 60611
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Ciudad De Buenos Aires,
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Columbus, OH
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Duarte, California 91010
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Goldsboro, North Carolina 27534
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Goshen, Indiana 46506
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Houston, TX
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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3991 Dutchmans Lane
Louisville, Kentucky 40207
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Madison, WI
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Marietta, Georgia 30060
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Morgantown, West Virginia 26506
(304) 293-0111
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445 E 69th St
New York, New York 10021
(212) 746-1067
Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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40 Cross Street
Norwalk, Connecticut 06850
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Portland, Oregon 97227
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Saint Louis, Missouri 63110
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Stanford, California 94305
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Westwood, Kansas 66205
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