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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03229200
Other study ID # PCYC-1145-LT
Secondary ID 2016-004356-30
Status Enrolling by invitation
Phase Phase 4
First received
Last updated
Start date May 22, 2017
Est. completion date May 10, 2027

Study information

Verified date June 2024
Source Pharmacyclics Switzerland GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region.


Description:

Multicenter, open-label, prospective treatment protocol that provides continued access to ibrutinib to subjects who have completed parent ibrutinib studies, are still benefitting from treatment with ibrutinib, and have no access to commercial ibrutinib for their underlying disease within their region. Subjects enrolled in this treatment protocol will receive oral continuous dosing with ibrutinib at the same dose and schedule they were receiving at the end of the respective parent study. Treatment may be continued as long as the subjects continue to derive benefit from treatment with ibrutinib until such time that ibrutinib becomes commercially available for the indication of the parent study. Clinical evaluations (including safety assessments) will be performed per local standard of care for each disease that was studied in the parent protocol. At each visit, all ongoing and new onset non-serious AEs leading to dose reduction or discontinuation, serious adverse events (SAEs), adverse events of special interest (AESI), pregnancy events, other malignancies, and special reporting situations will be recorded.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 600
Est. completion date May 10, 2027
Est. primary completion date May 10, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Subject must have participated in an eligible ibrutinib clinical trial, may derive clinical benefit from continued treatment or restart of treatment with ibrutinib in the opinion of the treating physician and does not have access to commercial ibrutinib within their region and/or the drug is not reasonably accessible to the patient within the respective region. - Ongoing continuous treatment with ibrutinib. - Subject must have completed all assessments in their parent protocol and want to continue treatment with ibrutinib. - Subject or their legally authorized representative must voluntarily sign and date an informed consent approved by an independent ethics committee (IEC)/institutional review board (IRB) to the long term treatment extension protocol and not withdrawn consent from the parent study. - Male and female subjects of reproductive potential who agree to use both a highly effective method of birth control and a barrier method during the period of therapy and for 90 days after the last dose of drug. Exclusion Criteria: - Meeting any requirement in the parent protocol to permanently discontinue ibrutinib treatment. - Any condition or situation which, in the opinion of the treating physician, may interfere significantly with a subject's participation in the protocol. - Female subjects who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this protocol or within 90 days of last dose of drug treatment. Male subjects who plan to father a child while enrolled in this protocol or within 90 days after the last dose of drug treatment. - Unwilling or unable to participate in all required evaluations and procedures. - Unable to understand the purpose and risks of the protocol and to provide a signed and dated informed consent form (ICF) and authorization to use protected health information.

Study Design


Intervention

Drug:
Ibrutinib
Subjects will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study.

Locations

Country Name City State
Australia Ballarat Health Services Ballarat Victoria
Australia Flinders Medical Centre Bedford Park South Australia
Australia Eastern Health Box Hill Victoria
Australia Monash Health-Monash Medical Centre Clayton Victoria
Australia St Vincent Hospital Fitzroy Victoria
Australia St. George Hospital Kogarah New South Wales
Australia Peter MacCallum Cancer Centre Melbourne Victoria
Australia Concord Repatriation General Hospital - Haematology Clinical Trials Sydney New South Wales
Australia Princess Alexandra Hospital Woolloongabba Queensland
Canada QEII Health Science Centre Halifax Nova Scotia
Canada McGill University Health Center Montréal Quebec
Canada Princess Margaret Cancer Centre Toronto Ontario
Czechia Hematology and Oncology Masaryk University Hospital Brno Brno
Czechia University Hospital Hradec Kralove Hradec Králové Kralovehradecky Kraj
Czechia University Hospital Pilsen Pilsen
Czechia Charles University Hospital, Prague Prague
Czechia Fakultni nemocnice Kralovske Vinohrady Praha 10
France CHU Hotel Dieu Nantes Loire Atlantique
France Centre Henri Becquerel Rouen Cedex
France Centre Hospitalier Saint Brieuc Saint-Brieuc
Hungary Central Hospital of Southern Pest - National Institute of Hematology and Infectious Diseases, Dept of Hematology and Stem Cell Budapest
Italy ASST Grande Ospedale Metropolitano Niguarda Milano
Italy Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico Milano
Italy Ospedale San Raffaele IRCCS Milano
Italy Azienda Ospedaliera di Padova Padova
Italy Fondazione IRCCS Policlinico San Matteo di Pavia Pavia
Italy Azienda Ospedaliera Città della Salute e della Scienza di Torino Torino
Italy Azienda Sanitaria Universitaria Integrata Udine Udine
Korea, Republic of Kyungpook National University Hospital (KNUH) Daegu
New Zealand North Shore Hospital Auckland
New Zealand Middlemore Hospital Papatoetoe Auckland
Poland Szpital Specjalistyczny w Brzozowie, Oddzial Hematologii Onkologicznej z Klinicznym Oddzialem Przeszczepiania Szpiku Brzozów Podkarpackie
Poland SPZOZ ZSM w Chorzowie Chorzów Silesia
Poland Klinika Hematologii i Transplantologii Gdansk Pomorskie
Poland Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika Lódz
Russian Federation Nizhniy Novgorod Regional Clinical Hospital n.a. N.A. Semashko Nizhniy Novgorod Nizhegorodskaya
Russian Federation SBI of Ryazan region "Regional Clinical Hospital" Ryazan' Ryazan Region
Russian Federation Almazov National Medical Research Centre Saint Petersburg
Russian Federation Russian Scientific and Research Institute of Hematology and Transfusiology of Federal Medical Biological Agency Saint Petersburg
Russian Federation Yaroslavl Regional Clinical Hospital Yaroslavl
Spain ICO - Hospital Germans Trias I Pujol Badalona Barcelona
Spain Hospital de Sanata Creus i Sant Pau Barcelona
Spain Hospital Vall d'Hebron Barcelona
Spain ICO l'Hospitalet - Hospital Duran i Reynals Barcelona
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Universitario Puerta de Hierro Majadahonda Madrid
Spain University Hospital of Salamanca Salamanca
Sweden Södra Älvsborg Hospital Borås Borås
Sweden Sunderby hospital Luleå Norrbotten
Sweden Karolinska Universitetssjukhuset, Solna Solna
Taiwan China Medical University Hospital Taichung
Taiwan National Taiwan University Hospital Taipei
Turkey Ankara Universitesi Tip Fakultesi Hastanesi Ankara
Turkey Gazi University Ankara
Turkey Pamukkale University Medical Faculty Denizli Pamukkale
Turkey VKV American Hospital Istanbul
Turkey Dokuz Eylul University Izmir
Ukraine CNE CCOHTPC of Cherkasy Regional Council Cherkasy
Ukraine CNCE City Clinical Hospital 4 of Dnipro City Council Dnipro
Ukraine SI Institute of Blood Pathology and Transfusion Medicine of AMSU Lviv
United Kingdom University Hospital of Wales Cardiff
United Kingdom Leeds Teaching Hospitals NHS Leeds
United Kingdom University College Hospitals NHS Foundation Trust London
United Kingdom The Christie NHS Foundation Trust Manchester
United States Emory University Atlanta Georgia
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Providence Health System - Southern California d/b/a Roy and Patricia Disney Family Cancer Center, The Roy & Patricia Disney Family Cancer Center Burbank California
United States University of Vermont Medical Center Burlington Vermont
United States Levine Cancer Institute Charlotte North Carolina
United States Northwestern University Chicago Illinois
United States University of Chicago Chicago Illinois
United States University of Cincinnati Medical Center Cincinnati Ohio
United States Cleveland Clinic Cleveland Ohio
United States Mid Ohio Oncology/Hematology Inc., DBA The Mark H. Zangmeister Center Columbus Ohio
United States The Ohio State University Columbus Ohio
United States Henry Ford Health System Detroit Michigan
United States City Of Hope National Medical Center Duarte California
United States San Juan Oncology Associates Farmington New Mexico
United States Southeastern Medical Oncology Center Goldsboro North Carolina
United States John Theurer Cancer Center, Hackensack UMC Hackensack New Jersey
United States M.D. Anderson Cancer Centre Houston Texas
United States University of Texas MD Anderson Cancer Center Houston Texas
United States UCSD Moores Cancer Center La Jolla California
United States TRIO - Comprehensive Cancer Centers of Nevada Las Vegas Nevada
United States University of California Los Angeles (UCLA) Los Angeles California
United States Norton Medical Plaza II, 3991 Dutchmans Lane Louisville Kentucky
United States Vanderbilt Ingram Cancer Center Nashville Tennessee
United States Northwell Health New Hyde Park New York
United States Memorial Sloan Kettering Cancer Center New York New York
United States Weill Cornell Medical College-New York Presbyterian Hospital New York New York
United States University of Pennsylvania Abramson Cancer Center Philadelphia Pennsylvania
United States University of Rochester Rochester New York
United States Swedish Cancer Institute Seattle Washington
United States Stanford University Stanford California
United States US Oncology Research, LLC The Woodlands Texas
United States Northwest Cancer Specialists, Compass Oncology Vancouver Washington
United States Wenatchee Valley Hospital and Clinics Wenatchee Washington
United States Yakima Valley Memorial Hospital Yakima Washington

Sponsors (2)

Lead Sponsor Collaborator
Pharmacyclics Switzerland GmbH Janssen Biotech, Inc., including Johnson & Johnson

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Czechia,  France,  Hungary,  Italy,  Korea, Republic of,  New Zealand,  Poland,  Russian Federation,  Spain,  Sweden,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary The objective of protocol PCYC-1145-LT is to provide long-term access to ibrutinib for subjects who meet the selection criteria. Assessment of percentage of patients rolling over from each parent study. The duration will be 3 years and will be re-evaluated.
Secondary Characterize the drug safety profile by collecting long-term safety data for ibrutinib. Number of participants with treatment emergent serious adverse events and adverse events of special interest as assessed by CTCAE v4.0. Up to 3 years and will be re-evaluated.
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