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

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

Sponsors

Lead Sponsor: Janssen Research & Development, LLC

Collaborator: Pharmacyclics LLC.

Source Janssen Research & Development, LLC
Brief 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.

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 ibrutinib access to participants in completed ibrutinib 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, "ibrutinib" will be used. Participants will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study until the investigator determines that the participant is no longer benefitting from treatment (ie, disease progression or unacceptable toxicity has occurred), the participant withdraws consent, alternative access to ibrutinib is available and feasible (example, participant assistance program or commercial source of ibrutinib), or for other reasons as defined in the protocol, or until the end of the study, whichever occurs earlier. Safety will be monitored throughout the study and summarized. Efficacy may be analyzed in combination with the data collected in the parent protocol. There is no formal hypothesis testing planned for this long-term extension study. Participants for whom alternative access to ibrutinib is not available and feasible can receive treatment with single-agent ibrutinib until end of study, which is defined as the time when all participants still receiving study treatment have transitioned to commercial or alternative access to ibrutinib, have stopped receiving ibrutinib treatment, or upon a decision by the sponsor to terminate the study, whichever occurs earlier.

Overall Status Enrolling by invitation
Start Date 2013-09-09
Completion Date 2026-12-31
Primary Completion Date 2026-12-31
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of participants affected by an adverse event Up to 30 days after the last dose of study drug, or until the start of a subsequent systemic anti-cancer therapy, if earlier
Secondary Outcome
Measure Time Frame
Number of participants with change in disease status 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
Enrollment 700
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ibrutinib

Description: 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.

Arm Group Label: Ibrutinib

Other Name: PCI-32765

Eligibility

Criteria:

Inclusion Criteria: - Participants must be currently participating in an ibrutinib clinical study considered complete and have received at least 6 months of treatment with ibrutinib. At study entry, participants must be actively receiving treatment with single-agent ibrutinib; or participants must have participated in an ibrutinib 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 ibrutinib 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 ibrutinib 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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Janssen Research & Development, LLC Clinical Trial Study Director Janssen Research & Development, LLC
Location
Facility:
City of Hope Cancer Center | Duarte, California, 91010, United States
University of California San Diego Medical Center | La Jolla, California, 92093, United States
University of California Los Angeles | Los Angeles, California, 90095, United States
Stanford University Medical Center | Stanford, California, 94305, United States
Stanford University | Stanford, California, 94305, United States
Norwalk Medical Group | Norwalk, Connecticut, 06850, United States
Northwest Georgia Oncology Centers PC | Marietta, Georgia, 30060, United States
Northwestern University Hospital | Chicago, Illinois, 60611, United States
Indiana University | Goshen, Indiana, 46526, United States
Kansas University Medical Center | Westwood, Kansas, 66205, United States
Louisville Oncology Suburban - Norton Cancer Institute | Louisville, Kentucky, 40207, United States
Dana Farber Cancer Center | Boston, Massachusetts, 02215, United States
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan, 48109, United States
Battle Creek Health Systm | Battle Creek, Michigan, 49016, United States
Karmanos Cancer Institute - Wayne State University | Detroit, Michigan, 48201, United States
Washington University | Saint Louis, Missouri, 63110, United States
Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire, 03756, United States
Hackensack University Medical Center | Hackensack, New Jersey, 07601, United States
Weill Medical College of Cornell University | New York, New York, 10021, United States
Memorial Sloan-Kettering Cancer Center | New York, New York, 10065, United States
Southeastern Medical Oncology Center | Goldsboro, North Carolina, 27534, United States
The Ohio State University- James Cancer Hospital | Columbus, Ohio, 43210, United States
Kaiser Permanente | Portland, Oregon, 97227, United States
University of Pennsylvania Medical Center | Philadelphia, Pennsylvania, 19104, United States
MD Anderson Cancer Center - University of Texas | Houston, Texas, 77030, United States
University of Virginia | Charlottesville, Virginia, 22908, United States
University of Washington | Seattle, Washington, 98109, United States
West Virginia University | Morgantown, West Virginia, 26506, United States
University of Wisconsin Carbone Cancer Center - Wisconsin Institute for Medical Research | Madison, Wisconsin, 53705, United States
Fundaleu | Ciudad de Buenos Aires, C1114AAP, Argentina
Royal Adelaide Hospital | Adelaide, 5000, Australia
John Fawkner Cancer Trial Centre | Coburg, 3058, Australia
Concord Hospital | Concord, 2139, Australia
Austin Health | Heidelberg, 3084, Australia
Peter MacCallum Cancer Institute | Melbourne, Australia
Royal Perth Hospital | Perth, 6847, Australia
Alfred Hospital | Prahran, 3181, Australia
UZA | Antwerp, 2650, Belgium
A.Z. Sint Jan | Brugge, 8000, Belgium
UCL - Saint Luc | Brussels, 1200, Belgium
UZ Gent - departement oncologie | Gent, 9000, Belgium
UZ Leuven Gasthuisberg | Leuven, 3000, Belgium
UCL Mont-Godinne | Yvoir, 5530, Belgium
INCA - Instituto Nacional Do Cancer | Rio de Janeiro, 20231-050, Brazil
Santa Casa da Misericórdia da Bahia - Hospital Santa Isabel | Salvador, 40050-410, Brazil
Instituto de Ensino E Pesquisa Sao Lucas | Sao Paulo, 01236-030, Brazil
Jewish General Hospital | Montreal, Quebec, H3T 1E2, Canada
Peking University People's Hospital | Beijing, 100044, China
Peking University Third Hospital | Beijing, 100083, China
Peking University First Hospital | Beijing, China
West China Hospital Sichuan University | Chengdu, 610041, China
Fujian Medical University | Fuzhou, 350001, China
Sun Yat-sen University Cancer Hospital | Guangzhou, 510060, China
Zhejiang University First Hospital | Hangzhou, 310003, China
Ruijin Hospital | Shanghai, 200025, China
Tangdu hospital the Fourth Military Medical | Shanxi, China
The First Affliated Hospital of Soochow University | Suzhou, Jaiangsu, China
The Institute of Hematological disease | Tianjin, 300070, China
Wuhan Union Hospital | Wuhan, 430022, China
Fundacion Santa Fe | Bogota, Colombia
Fundacion Oftalmologica de Santander - FOSCAL | Floridablanca, 681002, Colombia
Fakultni nemocnice Brno, Interni hematologicka a onkologicka klinika | Brno, 625 00, Czechia
Fakultni nemocnice Kralovske Vinohrady - Interni hematologicka klinika | Praha 10, 100 34, Czechia
Vseobecna fakultni nemocnice v Praze - I. interni klinika - klinika hematologie | Praha 2, 128 08, Czechia
Hopital Henri Mondor | Creteil, 94010, France
Hôpital E. Muller | Mulhouse, 68100, France
Hôpital Necker Enfants Malades | Paris cedex 15, 75743, France
HOPITAL SAINT LOUIS - Hematology / Oncology | Paris, 75010, France
Hopital Haut Leveque Service Maladie Du Sang | Pessac, 33604, France
CH LYON SUD - Hematology | Pierre Benite, 69495, France
CHU de Tours | Tours, 37044, France
Vivantes Klinikum Spandau-Klinik f. Innere Medizin Hämatologie/Onkologie/Gastroenterologie - Germany | Berlin, 13589, Germany
Universitätsklinikum Carl Gustav Carus; Med. Klinik und Poliklinik I - Hämatologische Ambulanz, Haus | Dresden, 01307, Germany
Universitätsklinikum Essen; Klinik f. Hämatologie- Germany | Essen, 45122, Germany
Universitätsklinikum Heidelberg Med. Klinik IV | Heidelberg, 69120, Germany
Universitätsklinikum des Saarlandes | Homburg/Saar, 66424, Germany
Gemeinschaftspraxis Dres. Uhle/Müller/Kröning/Jentsch-Ullrich - Germany | Magdeburg, 39104, Germany
OnkoNet Marburg GmbH | Marburg, 35037, Germany
Universitätsklinikum für Innere Med. III_Hämatologie, Onkologie...- Germany | Ulm, 89081, Germany
Laiko General Hospital - 1st department of Internal Medicine | Athens, 115 27, Greece
'G. Papanikolaou' Hospital of Thessaloniki | Thessalonikis, 570 10, Greece
Semmelweis Egyetem, I. Belgyogyaszati Klinika | Budapest N/a, 1083, Hungary
Szegedi Tudomanyegyetem II. Belgyogyaszati Klinika | Szeged, 6725, Hungary
St James's Hospital | Dublin, 00000, Ireland
Haemek Medical Center | Afula, Israel
Hillel Yaffe Medical Center - Oncology | Hadera, 38100, Israel
Rambam Health Care Campus | Haifa, 31096, Israel
Rabin Medical Center, Beilinson Campus | Petah Tikva, Israel
Sheba Medical Center | Ramat-Gan, 52621, Israel
Tel Aviv Sourasky Medical Center | Tel Aviv, 64239, Israel
ASST Grande Ospedale Metropolitano Niguarda | Milano, 20162, Italy
DIPARTIMENTO DI BIOTECNOLOGIE CELLULARI ED EMATOLOGIA - UNIVERSITà ''LA SAPIENZA'' | Roma, 00161, Italy
A.O.Citta della Salute e della Scienza di Torino | Torino, 10126, Italy
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital | Bunkyo-ku, 113-8677, Japan
Hokkaido University Hospital | Sapporo, 060-8648, Japan
National Cancer Center | Goyang-Si, 10408, Korea, Republic of
Seoul St. Mary's Hospital | Seoul, 06591, Korea, Republic of
Oaxaca Site Management Organization S.C. | Oaxaca, 68000, Mexico
VU medisch centrum - Afd.Interne - INT | Amsterdam, 1081 HV, Netherlands
Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny im. Ks. B. Markiewicza | Brzozow, 36-200, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich | Chorzów, 41-500, Poland
Uniwersyteckie Centrum Kliniczne | Gdansk, 80-952, Poland
Pratia MCM Krakow | Krakow, 30-510, Poland
Oddzial Hematologii | Opole, 45-061, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka | Slupsk, 76-200, Poland
Katedra i Klinika Hematologii , Nowotworów Krwi i Transplantacji Szpiku | Wroclaw, 50-367, Poland
Instituto Portugues de Oncologia | Lisboa, 1600, Portugal
Hospital De Santa Maria | Lisbon, 1649-035, Portugal
Instituto Portugues de Oncologia | Porto, 4200072, Portugal
Arkhangelsk Regional Clinical Hospital | Arkhangelsk, 163045, Russian Federation
Chelyabinsk Regiona Onc. Center | Chelyabinsk, 454087, Russian Federation
Emergency Hospital of Dzerzhinsk | Dzerzhinsk, 606019, Russian Federation
Cancer Research Center | Moscow N/a, 115478, Russian Federation
S.P. Botkin Moscow City Clinical Hospital | Moscow, 125284, Russian Federation
Regional Clinical Hospital n.a.Semashko | Nizhni Novgorod, 603126, Russian Federation
Medical Scientific Radiology - Center | Obninsk, 249020, Russian Federation
Perm Medical Sanitary Unit#1 | Perm, 614078, Russian Federation
Republican Hospital named by V.A.Baranova | Petrozavodsk, 185019, Russian Federation
Rostov Research Institute of Oncology | Rostov-Na-Donu, 344037, Russian Federation
Ryazan Regional Clinical Hospital | Ryazan, 390039, Russian Federation
Leningrad region clinical hospital | Saint, 194291, Russian Federation
Samara Region Clinical Hospital | Samara, 443095, Russian Federation
Oncological dispensary #2 | Sochi, 354057, Russian Federation
City Clinical Oncology Dispensary | St. Petersburg, 198255, Russian Federation
Clinical Research Institute of Hematology and Transfusiology | St.-Petersburg, 193024, Russian Federation
Federal Center of Heart, Blood and Endocrinology | St.-Petersburg, 197341, Russian Federation
Oncology Dispensary of Komi Republic | Syktyvkar, 167904, Russian Federation
Hospital Vall d'Hebron | Barcelona N/a, 00000, Spain
Inst. Cat. Doncologia-H Duran I Reynals | L'hospitalet De Llobregat, 08907, Spain
Hosp. Univ. de La Princesa | Madrid, 28006, Spain
Hosp. Gral. Univ. Gregorio Marañon | Madrid, 28007, Spain
Hosp. Univ. Infanta Leonor | Madrid, 28031, Spain
Fundacion Jimenez Diaz | Madrid, 28040, Spain
Clinica Universitaria de Navarra | Pamplona N/a, 31008, Spain
Hospital Clinico Universitario Salamanca | Salamanca, 37007, Spain
Sahlgrenska University hospital, Hematology Dept | Göteborg, SE-413 45, Sweden
Skanes universitetssjukhus | Lund, 22185, Sweden
Karolinska Universitetssjukhuset Solna, Centrum för Hematologi, Stockholm | Stockholm, 171 76, Sweden
Changhua Cristian Hospital | Changhua County, 500, Taiwan
Ankara University | Ankara, 6590, Turkey
American Hospital | Istanbul, 34365, Turkey
Istanbul University | Istanbul, 34390, Turkey
Dokuz Eylul Universitesi Tip Fakultesi | Izmir, 35340, Turkey
Erciyes University | Kayseri, 38039, Turkey
Communal Nonprofit Enterprise 'Cherkasy Regional Oncology Dispensary Of Cherkasy Regional Council' | Cherkasy, 18009, Ukraine
Dnepropetrovsk City Clinical Hospital #4, Regional Hematology Center | Dnepropetrovsk, 49102, Ukraine
SI Grigoriev Institute for Medical Radiology National Academy of Medical Science of Ukraine | Kharkiv, 61024, Ukraine
Khmelnitskiy Regional Hospital, Hematology Department | Khmelnitskiy, 29000, Ukraine
State Institution Scientific Center for Radiation Medicine Academy of Medical Sciences of Ukraine | Kiev, 03115, Ukraine
Institute of Blood Pathology and Transfusion Medicine of AMS of Ukraine | Lviv, 79044, Ukraine
Vinnytsya Regional Clinical Hospital named after M.I.Pirogov | Vinnitsa, 21018, Ukraine
University Hospitals Birmingham NHS Trust, | Birmingham, B15 2TH, United Kingdom
Royal Bournemouth Hospital | Bournemouth, BH7 7DW, United Kingdom
Colchester Hospital University NHS | Colchester, CO4 5JL, United Kingdom
Beatson West Of Scotland Cancer Centre | Glasgow, G12 0YN, United Kingdom
St James's Institute of Oncology | Leeds, LS9 7TF, United Kingdom
Leicester Royal Infirmary - Haematology | Leicester, LE1 5WW, United Kingdom
St Bartholomew's Hospital - Dept of Haematology | London, EC1A 7BE, United Kingdom
University College London Hospitals NHSFT | London, NW1 2BU, United Kingdom
King's College Hospital | London, SE5 9RS, United Kingdom
Christie Hospital | Manchester, 00000, United Kingdom
Nottingham University Hospitals NHS Trust | Nottingham, NG5 1PB, United Kingdom
Derriford Hospital | Plymouth, PL6 8DH, United Kingdom
Royal Hallamshire Hospital | Sheffield, S10 2JF, United Kingdom
Southampton General Hospital | Southampton, SO16 6YD, United Kingdom
Royal Marsden Hospital (Sutton) | Sutton, SM2 5PT, United Kingdom
Location Countries

Argentina

Australia

Belgium

Brazil

Canada

China

Colombia

Czechia

France

Germany

Greece

Hungary

Ireland

Israel

Italy

Japan

Korea, Republic of

Mexico

Netherlands

Poland

Portugal

Russian Federation

Spain

Sweden

Taiwan

Turkey

Ukraine

United Kingdom

United States

Verification Date

2021-09-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Ibrutinib

Type: Experimental

Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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