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    Summary
    EudraCT Number:2016-004356-30
    Sponsor's Protocol Code Number:PCYC-1145-LT
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-08-03
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2016-004356-30
    A.3Full title of the trial
    Extended treatment protocol for subjects continuing to benefit from ibrutinib after completion of ibrutinib clinical trials
    Protocollo di trattamento esteso per soggetti che continuano a trarre beneficio da ibrutinib dopo il completamento di sperimentazioni cliniche con ibrutinib
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-term safety of Ibrutinib
    Sicurezza a lungo termine di Ibrutinib
    A.3.2Name or abbreviated title of the trial where available
    Long-term safety of Ibrutinib
    Sicurezza a lungo termine di Ibrutinib
    A.4.1Sponsor's protocol code numberPCYC-1145-LT
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPHARMACYCLICS SWITZERLAND GMBH
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPharmacyclics Switzerland GmbH
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmacyclics Switzerland GmbH
    B.5.2Functional name of contact pointMedical Monitor
    B.5.3 Address:
    B.5.3.1Street AddressMhlentalstrasse 36
    B.5.3.2Town/ citySchaffhausen
    B.5.3.3Post codeCH-8200
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number0041763922152
    B.5.5Fax number0041525560801
    B.5.6E-mailv.fedorov@ch.pcyc.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numbersi prega di fare riferimento alla Cover Letter
    D.3 Description of the IMP
    D.3.1Product nameIbrutinib
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIbrutinib
    D.3.9.1CAS number 936563-96-1
    D.3.9.2Current sponsor codePCI32675
    D.3.9.4EV Substance CodeSUB120863
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number140
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    CLL, SLL, MCL, WM, DLBCL, FL, MZL, multiple myeloma, GvHD, pancreatic
    cancer, kidney cancer, bladder cancer, stomach cancer, throat cancer,
    colon cancer
    CLL, SLL, MCL, WM, DLBCL, FL, MZL, mieloma multiplo, GvHD, pancreas
    cancro, cancro del rene, cancro della vescica, cancro allo stomaco, cancro alla gola,
    cancro al colon
    E.1.1.1Medical condition in easily understood language
    CLL, SLL, MCL, WM, DLBCL, FL, MZL, multiple myeloma, GvHD, pancreatic cancer, kidney cancer, bladder cancer, stomach cancer, throat cancer, colon cancer
    CLL, SLL, MCL, WM, DLBCL, FL, MZL, multiple myeloma, GvHD, pancreatic
    cancer, kidney cancer, bladder cancer, stomach cancer, throat cancer,
    colon cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10008976
    E.1.2Term Chronic lymphocytic leukemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10012818
    E.1.2Term Diffuse large B-cell lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10041152
    E.1.2Term Small lymphocytic lymphoma, consistent with CLL (Working Formulation)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10043515
    E.1.2Term Throat cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10009944
    E.1.2Term Colon cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10033604
    E.1.2Term Pancreatic cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10028228
    E.1.2Term Multiple myeloma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10005003
    E.1.2Term Bladder cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10054695
    E.1.2Term Waldenstrom's macroglobulinemia
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10042080
    E.1.2Term Stomach cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10076596
    E.1.2Term Marginal zone lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10023400
    E.1.2Term Kidney cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10018799
    E.1.2Term GVHD
    E.1.2System Organ Class 100000004870
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 24.0
    E.1.2Level LLT
    E.1.2Classification code 10029473
    E.1.2Term Nodular (follicular) lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10061275
    E.1.2Term Mantle cell lymphoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To provide long-term access to ibrutinib for subjects who have been enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and are deriving benefit as assessed by the treating physician
    Per fornire un accesso a lungo termine a ibrutinib per i soggetti che sono stati arruolati negli studi di ibrutinib che sono stati completati secondo il protocollo parentale, che stanno attivamente ricevendo il trattamento con ibrutinib e che stanno ottenendo benefici come valutato dal medico
    E.2.2Secondary objectives of the trial
    Further key objective is to collect long-term safety data for these subjects treated with ibrutinib and to characterize the drug safety profile in long-term treatment with ibrutinib.
    Ulteriore obiettivo chiave ¿ quello di raccogliere dati di sicurezza a lungo termine per questi soggetti trattati con ibrutinib e per caratterizzare il profilo di sicurezza del farmaco nel trattamento a lungo termine con ibrutinib.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must currently be participating in an ibrutinib clinical trial, deriving clinical benefit from treatment with ibrutinib in the opinion of the treating physician and do no thave access to commercial ibrutinib within their region (eg, no regulatory approval ,insufficient reimbursement, and/or insufficient insurer coverage for the indication).
    2. Ongoing continuous treatment with ibrutinib: ibrutinib treatment may be on temporary hold at the time of enrollment with less than 28 continuous doses missed, however, the decision cannot have been made to permanently discontinue ibrutinib treatment.
    3. Subject must have completed all assessments in their parent protocol (eg, End-of-Treatment Visit is completed) and want to continue treatment with ibrutinib.
    4.Subject has provided informed consent to the long-term treatment extension protocol and not withdrawn consent from the parent study.
    5.Male and female subjects of reproductive potential who agree to use both a highly effective method of birth control (as desribed in the protocol) during the period of therapy and for 90 days for females and males after the last dose of drug.
    1. Il soggetto deve attualmente partecipare a uno studio clinico su ibrutinib, derivante un beneficio clinico dal trattamento con ibrutinib secondo il parere del medico curante e non ha accesso a questo medicinale nella sua regione (ad esempio, nessuna approvazione regolamentare, rimborso insufficiente e / o copertura assicurativa insufficiente per l'indicazione).
    2. Trattamento continuo continuo con ibrutinib: il trattamento con ibrutinib può essere temporaneamente sospeso al momento dell'arruolamento con meno di 28 dosi continue mancate, tuttavia, la decisione non può essere presa per interrompere definitivamente il trattamento con ibrutinib.
    3. Il soggetto deve aver completato tutte le valutazioni nel suo protocollo genitore (ad esempio, la visita di fine trattamento è stata completata) e desidera continuare il trattamento con ibrutinib.
    4. Il soggetto ha fornito il consenso informato al protocollo di estensione del trattamento a lungo termine e il consenso non ritirato dallo studio genitore.
    5. Soggetti maschi e femmine di potenziale riproduttivo che accettano di utilizzare sia un metodo di controllo delle nascite altamente efficace (come descritto nel protocollo) durante il periodo di terapia che 90 giorni per le femmine e i maschi dopo l'ultima dose di farmaco.
    E.4Principal exclusion criteria
    1. Meeting any requirement in the parent protocol to permanently discontinue ibrutinib treatment.
    2. Any condition or situation which, in the opinion of the treating physician, may interfere significantly with a subject’s participation in the protocol.
    3. 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.
    4. Unwilling or unable to participate in all required evaluations and procedures.
    5. 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(in accordance with national and local subject privacy regulations).
    1. Soddisfare qualsiasi requisito nel protocollo principale per interrompere definitivamente il trattamento con ibrutinib.
    2. Qualsiasi condizione o situazione che, secondo il parere del medico curante, possa interferire in modo significativo con la partecipazione di un soggetto al protocollo.
    3. Soggetti di sesso femminile che sono in stato di gravidanza, o che allattano al seno, o che intendono iniziare una gravidanza mentre sono iscritti a questo protocollo o entro 90 giorni dall'ultima dose di trattamento farmacologico. Soggetti di sesso maschile che pianificano di generare un figlio mentre sono iscritti a questo protocollo o entro 90 giorni dall'ultima dose di trattamento farmacologico.
    4. Non disposti o impossibilitati a partecipare a tutte le valutazioni e procedure richieste.
    5. Incapace di comprendere lo scopo e i rischi del protocollo e di fornire un modulo di consenso informato firmato e datato (ICF) e l'autorizzazione a utilizzare informazioni sanitarie protette (in conformità con le normative sulla privacy dei soggetti nazionali e locali).
    E.5 End points
    E.5.1Primary end point(s)
    There is no specific primary endpoint.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not applicable.
    E.5.2Secondary end point(s)
    Long-term safety.
    E.5.2.1Timepoint(s) of evaluation of this end point
    After the termination of the study.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA120
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    China
    Israel
    Korea, Democratic People's Republic of
    Korea, Republic of
    New Zealand
    Russian Federation
    Turkey
    Ukraine
    Austria
    Belgium
    France
    Germany
    Ireland
    Italy
    Poland
    Spain
    Sweden
    Czechia
    Greece
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 250
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 500
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Nessuno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-05
    P. End of Trial
    P.End of Trial StatusOngoing
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