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    Summary
    EudraCT Number:2020-004553-72
    Sponsor's Protocol Code Number:J2N-OX-JZNM(LOXO-BTK-20019)
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-03-09
    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 ConcernedGermany - BfArM
    A.2EudraCT number2020-004553-72
    A.3Full title of the trial
    A Phase 3 Open-Label, Randomized Study of LOXO-305 versus Investigator Choice of BTK Inhibitor in Patients with Previously Treated BTK Inhibitor Naïve Mantle Cell Lymphoma (BRUIN MCL-321)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to assess the effectiveness and safety of LOXO-305 compared to standard of care treatment chosen by the Investigator in patients with previously treated Mantle Cell Lymphoma
    A.4.1Sponsor's protocol code numberJ2N-OX-JZNM(LOXO-BTK-20019)
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04662255
    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 SponsorLoxo Oncology, Inc., a wholly owned subsidiary of Eli Lilly and Company
    B.1.3.4CountryUnited States
    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 supportLoxo Oncology, Inc., a wholly owned subsidiary of Eli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIQVIA RDS GmbH
    B.5.2Functional name of contact pointMedical and Scientific Services
    B.5.3 Address:
    B.5.3.1Street AddressUnterschweinstiege 2-14.
    B.5.3.2Town/ cityFrankfurt am Main
    B.5.3.3Post code60549
    B.5.3.4CountryGermany
    B.5.6E-mailmarialeticia.solari@iqvia.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 numberEU/3/21/2450
    D.3 Description of the IMP
    D.3.1Product namepirtobrutinib
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNnot available
    D.3.9.1CAS number 2101700-15-4
    D.3.9.2Current sponsor codeLOXO-305
    D.3.9.3Other descriptive nameLY3527727
    D.3.9.4EV Substance CodeSUB215610
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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.IMP: 2
    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 numberEU/3/21/2450
    D.3 Description of the IMP
    D.3.1Product namepirtobrutinib
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNnot available
    D.3.9.1CAS number 2101700-15-4
    D.3.9.2Current sponsor codeLOXO-305
    D.3.9.3Other descriptive nameLY3527727
    D.3.9.4EV Substance CodeSUB215610
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name IMBRUVICA
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIbrutinib
    D.3.4Pharmaceutical form Tablet
    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.3.9.3Other descriptive nameIBRUTINIB
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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 Yes
    D.2.1.1.1Trade name IMBRUVICA
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameIbrutinib
    D.3.4Pharmaceutical form Tablet
    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.3.9.3Other descriptive nameIBRUTINIB
    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 number560
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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.IMP: 5
    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 numberEU/3/21/2450
    D.3 Description of the IMP
    D.3.1Product namepirtobrutinib
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNnot available
    D.3.9.1CAS number 2101700-15-4
    D.3.9.2Current sponsor codeLOXO-305
    D.3.9.3Other descriptive nameLY3527727
    D.3.9.4EV Substance CodeSUB215610
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    Mantle cell lymphoma
    E.1.1.1Medical condition in easily understood language
    a cancer of white blood cells (developing in a certain part of the lymph node), which help the body fight infections
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10026799
    E.1.2Term Mantle cell lymphoma NOS
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare PFS of pirtobrutinib as monotherapy (Arm A) to Investigator choice of covalent BTK inhibitor monotherapy (Arm
    B) in patients with previously treated MCL
    E.2.2Secondary objectives of the trial
    -To compare efficacy of pirtobrutinib as monotherapy (Arm A) to Investigator choice of covalent BTK inhibitor monotherapy (Arm B) treatment arms
    -To evaluate the safety and tolerability of each treatment arm
    -To evaluate the patient-reported outcomes
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • At least 18 years of age
    • Confirmed diagnosis by local laboratory of MCL with documentation of
    overexpression of cyclin D1 with at least one B-cell marker (e.g., CD19,
    CD20, or PAX5) and/or t (11;14) by cytogenetics, fluorescent in situ
    hybridization (FISH) or polymerase chain reaction.
    • Previously treated with at least one prior line of systemic therapy for
    MCL.
    • Measurable disease by PET-CT and/or CT/MRI as defined by Lugano
    criteria and aligned with protocol imaging requirements:
    - at least one nodal lesion (> 1.5 cm in long axis) or extranodal
    lesion (> 1.0 cm in long axis) measurable in 2 dimensions, not
    previously radiated (unless progression has been radiographically
    documented following radiation therapy).
    • Documented evidence of radiographically and/or histologically
    confirmed PD on the most recent line of therapy or relapse prior to study
    enrollment.
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    • Adequate organ function
    • Must have life expectancy of at least 3 months
    E.4Principal exclusion criteria
    • Current suspected or confirmed active central nervous system (CNS)
    involvement with MCL or previous CNS involvement.
    • Prior treatment with an approved or investigational BTK inhibitor.
    • Major surgery within 4 weeks prior to randomization.
    • History of bleeding diathesis.
    • History of stroke or intracranial hemorrhage within 6 months of
    randomization.
    • History of allogeneic or autologous stem cell transplant (SCT) or
    chimeric antigen receptor-modified T-cell (CAR-T) therapy within 60
    days of randomization.
    • Significant cardiovascular disease.
    • Prolongation of the QT interval corrected for heart rate (QTcF) > 470
    msec during Screening.
    • Known human immunodeficiency virus (HIV) infection, regardless of
    CD4 count.
    • Known active hepatitis B virus (HBV) or hepatitis C virus (HCV)
    infection.
    • Known active cytomegalovirus (CMV) infection. Unknown or negative
    status are eligible.
    • Pregnancy during the study or within 3
    months of the last dose of study treatment.
    • Clinically significant active malabsorption syndrome or other condition
    likely to affect GI absorption of the study drug.
    • Evidence of other clinically significant uncontrolled condition(s)
    including but not limited to, uncontrolled systemic bacterial, viral, fungal
    or parasitic infection (except for fungal nail infection), or other clinically
    significant active disease process which in the opinion of the
    Investigator and medical monitor may pose a risk for patient
    participation. Screening for chronic conditions is not required.
    • History of second malignancy unless in remission for at least 2 years;
    in-situ carcinomas not requiring treatment intervention, non-melanoma skin cancer curatively treated, nonmetastatic
    breast, or nonmetastatic prostate cancer where hormonal therapy is
    being continued as standard of care are allowed.
    Prior/Concomitant Therapy
    • Ongoing chronic treatment with strong cytochrome P450 3A4
    (CYP3A4) inhibitors or inducers which cannot be stopped within 3-5
    half-lives of the CYP3A inhibitor therapy prior to start of study drug
    treatment.
    Because of their effect on CYP3A4, use of any of the following within 3
    days of study therapy start is prohibited: Grapefruit or grapefruit
    products, Seville oranges or products from Seville oranges, Star fruit or
    star fruit products.
    • Steroid use with antineoplastic intent within 7 days of study drug
    initiation.
    • Patients requiring therapeutic anticoagulation with warfarin or another
    vitamin K antagonist.
    • Vaccination with a live vaccine within 28 days prior to randomization.
    • Have a known hypersensitivity to any of the excipients of pirtobrutinib
    or to the intended covalent BTK inhibitor if randomized to control arm.
    • Laction, or plan to breastfeed during the study or within 2 weeks of the
    last dose of study treatment
    E.5 End points
    E.5.1Primary end point(s)
    Assessed by independent review committee (IRC)
    • PFS per Lugano criteria
    E.5.1.1Timepoint(s) of evaluation of this end point
    The time from the date of randomization until PD or death from any cause, whichever occurs first.
    E.5.2Secondary end point(s)
    Assessed by both Investigator assessment and IRC
    • ORR per Lugano criteria
    • DOR per Lugano criteria
    Assessed by Investigator assessment:
    • PFS per Lugano criteria
    • OS
    • Event-free survival (EFS)
    • Time to treatment failure (TTF)
    • Time to next treatment (TTNT)
    • Progression-free survival 2 (PFS2)
    Incidence and severity of SAEs, AEs, deaths, and clinical laboratory
    abnormalities per Common Terminology
    Criteria for Adverse Events (CTCAE v5.0)
    • Comparative tolerability: proportion of time with high side-effect
    burden
    • Time to worsening (TTW) of MCL-related symptoms
    E.5.2.1Timepoint(s) of evaluation of this end point
    ORR - achieving a BOR of CR or PR
    DOR - earlier of the documentation of definitive PD or death from any
    cause
    PFS - PD or death from any cause, whichever occurs first
    OS - death from any cause
    EFS - date of PD or start of subsequent anticancer therapy for MCL or
    withdrawal from treatment due to toxicity or death, whichever occurs
    first
    TTF - composite endpoint, discontinuation of treatment for any reason
    TTNT - date of subsequent anticancer therapy for MCL, or death,
    whichever occurs first
    PFS 2 - disease progression on next line treatment, or death from any
    cause
    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 Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA71
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    New Zealand
    Switzerland
    Taiwan
    Australia
    Canada
    China
    Israel
    Japan
    Korea, Republic of
    Russian Federation
    United Kingdom
    United States
    Austria
    Belgium
    Czechia
    Denmark
    France
    Germany
    Hungary
    Ireland
    Italy
    Netherlands
    Poland
    Portugal
    Spain
    E.8.7Trial has a data monitoring committee Yes
    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
    End of the study is estimated at approximately 24 months from the last subject randomized
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months7
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 300
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 169
    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)
    Patients receiving pirtobrutinib may continue on this treatment until
    the patient is able to obtain commercially available pirtobrutinib in
    their respective country, if the patient does not meet criteria requiring
    discontinuation of treatment, and the patient's participation in the
    study has not ended.
    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 Decision2021-07-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-20
    P. End of Trial
    P.End of Trial StatusOngoing
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