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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01804686




Registration number
NCT01804686
Ethics application status
Date submitted
4/03/2013
Date registered
5/03/2013
Date last updated
26/10/2024

Titles & IDs
Public title
A Long-term Extension Study of PCI-32765 (Ibrutinib)
Scientific title
A Phase 3b, Multicenter, Open-label, PCI-32765 (Ibrutinib) Long-term Extension Study
Secondary ID [1] 0 0
2012-004225-24
Secondary ID [2] 0 0
CR100955
Universal Trial Number (UTN)
Trial acronym
CAN3001
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia 0 0
Small Lymphocytic Lymphoma 0 0
Mantle Cell Lymphoma 0 0
Follicular Lymphoma 0 0
Diffuse Large B-cell Lymphoma 0 0
Waldenstrom Macroglobulinemia 0 0
Chronic Graft Versus Host Disease 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ibrutinib

Experimental: Ibrutinib -


Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants affected by an adverse event
Timepoint [1] 0 0
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 [1] 0 0
Number of participants with change in disease status
Timepoint [1] 0 0
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

Eligibility
Key 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; or participants must be currently participating in study PCI-32765LYM1002. At study entry, participants must be actively receiving combination treatment with ibrutinib and nivolumab or single-agent ibrutinib
* Investigator's assessment that the benefit of continued ibrutinib therapy as a single agent or in combination with nivolumab will outweigh the risks
* Agrees to protocol-defined use of effective contraception
* Negative blood or urine pregnancy test at screening
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/01/2027
Actual
Sample size
Target
700
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
John Fawkner Cancer Trial Centre - Coburg
Recruitment hospital [3] 0 0
Concord Hospital - Concord
Recruitment hospital [4] 0 0
Austin Health - Heidelberg
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Institute - Melbourne
Recruitment hospital [6] 0 0
Royal Perth Hospital - Perth
Recruitment hospital [7] 0 0
Alfred Hospital - Prahran
Recruitment hospital [8] 0 0
Adventist Health Care Limited trading as San Clinical Trials Unit - Wahroonga
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3058 - Coburg
Recruitment postcode(s) [3] 0 0
2139 - Concord
Recruitment postcode(s) [4] 0 0
3084 - Heidelberg
Recruitment postcode(s) [5] 0 0
3000 - Melbourne
Recruitment postcode(s) [6] 0 0
6847 - Perth
Recruitment postcode(s) [7] 0 0
3181 - Prahran
Recruitment postcode(s) [8] 0 0
2076 - Wahroonga
Recruitment outside Australia
Country [1] 0 0
United States of America
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California
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Connecticut
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Georgia
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Illinois
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Indiana
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Kansas
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Kentucky
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Massachusetts
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Michigan
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Missouri
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New Hampshire
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New Jersey
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New York
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North Carolina
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Ohio
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Oregon
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Pennsylvania
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South Dakota
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Texas
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Virginia
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Washington
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United States of America
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West Virginia
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United States of America
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Wisconsin
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Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Ciudad de Buenos Aires
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Belgium
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Antwerp
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Belgium
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Brugge
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Belgium
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Brussels
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Belgium
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Gent
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Belgium
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Leuven
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Belgium
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Yvoir
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Brazil
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Rio De Janeiro
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Brazil
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Salvador
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Brazil
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Sao Paulo
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Canada
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Quebec
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China
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Beijing
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China
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Chengdu
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China
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Fuzhou
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China
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Guangzhou
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China
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Hangzhou
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China
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Shanghai
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China
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Shanxi
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China
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Suzhou, Jaiangsu
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China
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Tianjin
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China
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Wuhan
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Colombia
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Bogota
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Colombia
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Floridablanca
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Czechia
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Brno
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Czechia
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Praha 10
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Czechia
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Praha 2
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France
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Creteil
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France
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Mulhouse
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France
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Paris cedex 15
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France
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Paris
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France
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Pessac
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France
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Pierre Benite
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France
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Tours
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Germany
State/province [58] 0 0
Berlin
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Germany
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Dresden
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Germany
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Essen
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Germany
State/province [61] 0 0
Gießen
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Germany
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Heidelberg
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Germany
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Homburg/Saar
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Germany
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Magdeburg
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Germany
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Marburg
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Germany
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Ulm
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Greece
State/province [67] 0 0
Athens
Country [68] 0 0
Greece
State/province [68] 0 0
Thessalonikis
Country [69] 0 0
Hungary
State/province [69] 0 0
Budapest N/a
Country [70] 0 0
Hungary
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Szeged
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Ireland
State/province [71] 0 0
Dublin
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Israel
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Afula
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Israel
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Hadera
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Israel
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Haifa
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Israel
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Petah Tikva
Country [76] 0 0
Israel
State/province [76] 0 0
Ramat-Gan
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Israel
State/province [77] 0 0
Tel Aviv
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Italy
State/province [78] 0 0
Milano
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Italy
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Roma
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Italy
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Torino
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Japan
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Bunkyo-ku
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Japan
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Hiroshima shi
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Japan
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Sapporo-shi
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Korea, Republic of
State/province [84] 0 0
Goyang-Si
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Korea, Republic of
State/province [85] 0 0
Seoul
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Mexico
State/province [86] 0 0
Oaxaca
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Netherlands
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Amsterdam
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Poland
State/province [88] 0 0
Brzozow
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Poland
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Chorzów
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Poland
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Gdansk
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Poland
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Krakow
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Poland
State/province [92] 0 0
Opole
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Poland
State/province [93] 0 0
Slupsk
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Poland
State/province [94] 0 0
Wroclaw
Country [95] 0 0
Portugal
State/province [95] 0 0
Lisboa
Country [96] 0 0
Portugal
State/province [96] 0 0
Lisbon
Country [97] 0 0
Portugal
State/province [97] 0 0
Porto
Country [98] 0 0
Puerto Rico
State/province [98] 0 0
San Juan
Country [99] 0 0
Russian Federation
State/province [99] 0 0
Arkhangelsk
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Russian Federation
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Chelyabinsk
Country [101] 0 0
Russian Federation
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Dzerzhinsk
Country [102] 0 0
Russian Federation
State/province [102] 0 0
Moscow N/a
Country [103] 0 0
Russian Federation
State/province [103] 0 0
Moscow
Country [104] 0 0
Russian Federation
State/province [104] 0 0
Nizhni Novgorod
Country [105] 0 0
Russian Federation
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Obninsk
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Russian Federation
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Perm
Country [107] 0 0
Russian Federation
State/province [107] 0 0
Petrozavodsk
Country [108] 0 0
Russian Federation
State/province [108] 0 0
Rostov-Na-Donu
Country [109] 0 0
Russian Federation
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Ryazan
Country [110] 0 0
Russian Federation
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Saint
Country [111] 0 0
Russian Federation
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Samara
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Russian Federation
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Sankt-Peterburg
Country [113] 0 0
Russian Federation
State/province [113] 0 0
Sochi
Country [114] 0 0
Russian Federation
State/province [114] 0 0
St. Petersburg
Country [115] 0 0
Russian Federation
State/province [115] 0 0
St.-Petersburg
Country [116] 0 0
Russian Federation
State/province [116] 0 0
Syktyvkar
Country [117] 0 0
Spain
State/province [117] 0 0
Barcelona N/a
Country [118] 0 0
Spain
State/province [118] 0 0
L'hospitalet De Llobregat
Country [119] 0 0
Spain
State/province [119] 0 0
Madrid
Country [120] 0 0
Spain
State/province [120] 0 0
Pamplona N/a
Country [121] 0 0
Spain
State/province [121] 0 0
Salamanca
Country [122] 0 0
Sweden
State/province [122] 0 0
Göteborg
Country [123] 0 0
Sweden
State/province [123] 0 0
Lund
Country [124] 0 0
Sweden
State/province [124] 0 0
Stockholm
Country [125] 0 0
Taiwan
State/province [125] 0 0
Changhua County
Country [126] 0 0
Turkey
State/province [126] 0 0
Ankara
Country [127] 0 0
Turkey
State/province [127] 0 0
Istanbul
Country [128] 0 0
Turkey
State/province [128] 0 0
Izmir
Country [129] 0 0
Turkey
State/province [129] 0 0
Kayseri
Country [130] 0 0
Ukraine
State/province [130] 0 0
Cherkasy
Country [131] 0 0
Ukraine
State/province [131] 0 0
Dnepropetrovsk
Country [132] 0 0
Ukraine
State/province [132] 0 0
Kharkiv
Country [133] 0 0
Ukraine
State/province [133] 0 0
Khmelnitskiy
Country [134] 0 0
Ukraine
State/province [134] 0 0
Kiev
Country [135] 0 0
Ukraine
State/province [135] 0 0
Lviv
Country [136] 0 0
Ukraine
State/province [136] 0 0
Vinnitsa
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Birmingham
Country [138] 0 0
United Kingdom
State/province [138] 0 0
Bournemouth
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Colchester
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Glasgow
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Leeds
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Leicester
Country [143] 0 0
United Kingdom
State/province [143] 0 0
London
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Manchester
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Nottingham
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Plymouth
Country [147] 0 0
United Kingdom
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Sheffield
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United Kingdom
State/province [148] 0 0
Southampton
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United Kingdom
State/province [149] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Janssen Research & Development, LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Pharmacyclics LLC.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01804686
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01804686