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ACTIVE NOT RECRUITING
NCT01804686
PHASE3

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

539

Start Date

2013-09-09

Completion Date

2029-12-31

Last Updated

2026-11-03

Healthy Volunteers

No

Interventions

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.

Locations (156)

Duarte, California, United States

La Jolla, California, United States

Los Angeles, California, United States

Orange, California, United States

Stanford, California, United States

Norwalk, Connecticut, United States

Marietta, Georgia, United States

Chicago, Illinois, United States

Goshen, Indiana, United States

Westwood, Kansas, United States

Louisville, Kentucky, United States

Boston, Massachusetts, United States

Ann Arbor, Michigan, United States

Battle Creek, Michigan, United States

Detroit, Michigan, United States

St Louis, Missouri, United States

Lebanon, New Hampshire, United States

Hackensack, New Jersey, United States

New York, New York, United States

Goldsboro, North Carolina, United States

Columbus, Ohio, United States

Eugene, Oregon, United States

Portland, Oregon, United States

Philadelphia, Pennsylvania, United States

Sioux Falls, South Dakota, United States

Houston, Texas, United States

Charlottesville, Virginia, United States

Seattle, Washington, United States

Morgantown, West Virginia, United States

Madison, Wisconsin, United States

Ciudad Autonoma Buenos Aires, Argentina

Ciudad de Buenos Aires, Argentina

Adelaide, Australia

Coburg, Australia

Concord, Australia

Heidelberg, Australia

Melbourne, Australia

Perth, Australia

Prahran, Australia

Wahroonga, Australia

Antwerp, Belgium

Bruges, Belgium

Brussels, Belgium

Ghent, Belgium

Leuven, Belgium

Yvoir, Belgium

Rio de Janeiro, Brazil

Salvador, Brazil

São Paulo, Brazil

Montreal, Quebec, Canada

Beijing, China

Chengdu, China

Fuzhou, China

Guangzhou, China

Hangzhou, China

Shanghai, China

Shanxi, China

Suzhou, China

Tianjin, China

Wuhan, China

Bogotá, Colombia

Floridablanca, Colombia

Brno, Czechia

Prague, Czechia

Créteil, France

Mulhouse, France

Paris, France

Pessac, France

Pierre-Bénite, France

Tours, France

Berlin, Germany

Dresden, Germany

Essen, Germany

Giessen, Germany

Heidelberg, Germany

Homburg/Saar, Germany

Magdeburg, Germany

Marburg, Germany

Ulm, Germany

Athens, Greece

Thessalonikis, Greece

Budapest, Hungary

Szeged, Hungary

Dublin, Ireland

Afula, Israel

Hadera, Israel

Haifa, Israel

Petah Tikva, Israel

Ramat Gan, Israel

Tel Aviv, Israel

Bunkyō City, Japan

Hiroshima, Japan

Oaxaca City, Mexico

Amsterdam, Netherlands

Brzozów, Poland

Chorzów, Poland

Gdansk, Poland

Klinika Nowotworow Ukladu Chlonnego, Poland

Krakow, Poland

Opole, Poland

And 56 more locations on ClinicalTrials.gov