Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib.

Solid Tumor Clinical Trial

Official title:

Extended Treatment Protocol for Subjects Continuing to Benefit From Ibrutinib After Completion of Ibrutinib Clinical Trials.

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
• Start date: May 22, 2017
• Est. completion date: July 2, 2027

Study information

• Verified date: November 2022
• Source: Pharmacyclics Switzerland GmbH
• Contact: n/a
• Is FDA regulated: No
• 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: July 2, 2027
• Est. primary completion date: July 2, 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.

Related Conditions & MeSH terms

• Graft Vs Host Disease
• Leukemia, B-cell
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Solid Tumor

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.