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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01804686
Recruitment Status : Enrolling by invitation
First Posted : March 5, 2013
Last Update Posted : December 13, 2019
Sponsor:
Collaborator:
Pharmacyclics LLC.
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Mantle Cell Lymphoma Follicular Lymphoma Diffuse Large B-cell Lymphoma Drug: PCI-32765 (Ibrutinib) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study
Actual Study Start Date : September 9, 2013
Estimated Primary Completion Date : December 29, 2021
Estimated Study Completion Date : December 31, 2026


Arm Intervention/treatment
Experimental: PCI-32765 (Ibrutinib) Drug: PCI-32765 (Ibrutinib)
PCI-32765 (Ibrutinib) will be given orally as capsules, once daily continuously, according to the current dosing regimen established in the parent PCI-32765 clinical study (560 mg, 420 mg, 280 mg, or 140 mg), at approximately the same time each day.




Primary Outcome Measures :
  1. Number of participants affected by an adverse event [ Time Frame: Up to 30 days after the last dose of study medication ]

Secondary Outcome Measures :
  1. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01804686


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

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01804686     History of Changes
Other Study ID Numbers: CR100955
2012-004225-24 ( EudraCT Number )
PCI-32765CAN3001 ( Other Identifier: Janssen Research & Development, LLC )
First Posted: March 5, 2013    Key Record Dates
Last Update Posted: December 13, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Research & Development, LLC:
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
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Follicular
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, B-Cell
Lymphoma, Mantle-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia
Lymphoma, Non-Hodgkin
Leukemia, B-Cell