Clinical trial • Phase III • Oncology
PIRTOBRUTINIB for Mantle cell lymphoma
Phase III trial of PIRTOBRUTINIB for Mantle cell lymphoma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Mantle cell lymphoma
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Orphan Drug
- Yes
Key dates
- Initial CTIS Submission Date
- 29-04-2024
- First CTIS Authorization Date
- 12-06-2024
Trial design
Randomised, open-label, arm a: pirtobrutinib (loxo-305, oral tablet; product entry lists max daily dose 200 mg). arm b: investigator choice of covalent bruton’s tyrosine kinase (btk) inhibitor monotherapy (examples in product list include ibrutinib; film-coated tablet; product entry lists max daily dose 560 mg).-controlled Phase III trial across 54 sites in Italy, Netherlands, Poland and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Arm A: pirtobrutinib (LOXO-305, oral tablet; product entry lists max daily dose 200 mg). Arm B: Investigator choice of covalent Bruton’s tyrosine kinase (BTK) inhibitor monotherapy (examples in product list include Ibrutinib; film-coated tablet; product entry lists max daily dose 560 mg).
- Target Sample Size
- 352
Eligibility
Recruits 352 adults.
Inclusion criteria
- {"criterion_text":"- Confirmed Mantle Cell Lymphoma (MCL) diagnosis\n- Previously treated with at least one prior line of systemic therapy for MCL\n- Measurable disease per Lugano criteria\n- Eastern Cooperative Oncology Group (ECOG) 0-2\n- Absolute neutrophil count ≥ 0.75 × 109/L without granulocyte-colony stimulating factor support within 7 days of screening\n- Hemoglobin ≥ 8 g/dL not requiring transfusion support or growth factors within 7 days of screening\n- Platelets ≥ 50 × 109/L not requiring transfusion support or growth factors within 7 days of screening.\n- AST and ALT ≤ 3.0 x upper limit of normal (ULN)\n- Total bilirubin ≤ 1.5 x ULN.\n- Creatinine clearance of ≥ 30 mL/min according to Cockcroft/Gault Formula"}
Exclusion criteria
- {"criterion_text":"- Prior treatment with an approved or investigational BTK inhibitor\n- Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.\n- Vaccination with live vaccine within 28 days prior to randomization\n- History of bleeding diathesis\n- History of stroke or intracranial hemorrhage within 6 months of randomization\n- History of allogeneic or autologous stem cell transplant (SCT) or chimeric antigen receptor modified T-cell (CAR-T) therapy within 60 days of randomization\n- Clinically significant cardiovascular disease\n- Prolonged QT interval corrected using Fridericia's formula (QTcF) > 470 ms on 2/3 consecutive ECGs, and mean QTcF>470 ms on all 3 ECGs\n- Known HIV infection or active HBV, HCV, or CMV infections. (Certain participants with controlled HBV infections may still be eligible)\n- Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption\n- 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."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Assessed by independent review committee (IRC) • Progression-free survival (PFS) per Lugano criteria","definition_or_measurement_approach":"Assessed by independent review committee (IRC); Progression-free survival (PFS) measured per Lugano criteria"}
Recruitment
- Planned Sample Size
- 352
- Recruitment Window Months
- 59
- Consent Approach
- Informed consent is documented via subject information sheets and informed consent forms. Country- and language-specific ICFs are provided (documents available in English, French, German, Italian, Dutch, Polish, Portuguese, Spanish, Czech and other local versions). Consent is provided by participants; specific details on assent or parental consent for vulnerable populations are not specified in the available record.
Geography
- Total Number Of Sites
- 54
- Total Number Of Participants
- 197
Italy
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 17-06-2024
- Processing Time Days
- 14
- Number Of Sites
- 10
- Number Of Participants
- 28
Sites
- Site Name
- IRCCS Centro Di Riferimento Oncologico Della Basilicata
- Department Name
- Ematologia e trapianto di cellule staminali
- Principal Investigator Name
- Giuseppe Pietrantuono
- Principal Investigator Email
- giuseppe.pietrantuono@crob.it
- Contact Person Name
- Giuseppe Pietrantuono
- Contact Person Email
- giuseppe.pietrantuono@crob.it
- Site Name
- Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo
- Department Name
- SC Ematologia
- Principal Investigator Name
- Manuela Zanni
- Principal Investigator Email
- manuela.zanni@ospedale.al.it
- Contact Person Name
- Manuela Zanni
- Contact Person Email
- manuela.zanni@ospedale.al.it
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- UO Clinica Ematologica
- Principal Investigator Name
- Roberto Lemoli
- Principal Investigator Email
- roberto.lemoli@unige.it
- Contact Person Name
- Roberto Lemoli
- Contact Person Email
- roberto.lemoli@unige.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- SSD Ematologia e Trapianti CSE
- Principal Investigator Name
- Gerardo Musuraca
- Principal Investigator Email
- gerardo.musuraca@irst.emr.it
- Contact Person Name
- Gerardo Musuraca
- Contact Person Email
- gerardo.musuraca@irst.emr.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- U.O.C. Ematologia
- Principal Investigator Name
- Pier Luigi Zinzani
- Principal Investigator Email
- pierluigi.zinzani@unibo.it
- Contact Person Name
- Pier Luigi Zinzani
- Contact Person Email
- pierluigi.zinzani@unibo.it
- Site Name
- Azienda USL IRCCS Di Reggio Emilia
- Department Name
- SC Ematologia
- Principal Investigator Name
- Fiorella Ilariucci
- Principal Investigator Email
- fiorella.ilariucci@ausl.re.it
- Contact Person Name
- Fiorella Ilariucci
- Contact Person Email
- fiorella.ilariucci@ausl.re.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Reparto di Oncoematologia
- Principal Investigator Name
- Andres Jose Maria Ferreri
- Principal Investigator Email
- ferreri.andres@hsr.it
- Contact Person Name
- Andres Jose Maria Ferreri
- Contact Person Email
- ferreri.andres@hsr.it
- Site Name
- Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
- Department Name
- UO Ematologia I
- Principal Investigator Name
- Caterina Patti
- Principal Investigator Email
- k.patti@ospedaliriunitipalermo.it
- Contact Person Name
- Caterina Patti
- Contact Person Email
- k.patti@ospedaliriunitipalermo.it
- Site Name
- Azienda Socio Sanitaria Territoriale Dei Sette Laghi
- Department Name
- Dipar&mento di Ematologia
- Principal Investigator Name
- Marco Brociner
- Principal Investigator Email
- marco.brociner@asst-settelaghi.it
- Contact Person Name
- Marco Brociner
- Contact Person Email
- marco.brociner@asst-settelaghi.it
- Site Name
- Azienda Unita Sanitaria Locale Della Romagna
- Department Name
- UO Oncologia e Ematologia
- Principal Investigator Name
- Monica Tani
- Principal Investigator Email
- monica.tani@auslromagna.it
- Contact Person Name
- Monica Tani
- Contact Person Email
- monica.tani@auslromagna.it
Netherlands
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 12-06-2024
- Processing Time Days
- 9
- Number Of Sites
- 2
- Number Of Participants
- 4
Sites
- Site Name
- Bravis Ziekenhuis
- Department Name
- Internal Medicine
- Principal Investigator Name
- Nicole de Graauw
- Principal Investigator Email
- n.degraauw@bravis.nl
- Contact Person Name
- Nicole de Graauw
- Contact Person Email
- n.degraauw@bravis.nl
- Site Name
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
- Department Name
- Hematology
- Principal Investigator Name
- Jeanette Doorduijn
- Principal Investigator Email
- j.doorduijn@erasmusmc.nl
- Contact Person Name
- Jeanette Doorduijn
- Contact Person Email
- j.doorduijn@erasmusmc.nl
Poland
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 13-06-2024
- Processing Time Days
- 10
- Number Of Sites
- 6
- Number Of Participants
- 53
Sites
- Site Name
- Pratia S.A.
- Department Name
- Pratia MCM Krakow
- Principal Investigator Name
- Wojciech Jurczak
- Principal Investigator Email
- wojciech.jurczak@pratia.com
- Contact Person Name
- Wojciech Jurczak
- Contact Person Email
- wojciech.jurczak@pratia.com
- Site Name
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
- Department Name
- Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych
- Principal Investigator Name
- Tomasz Wrobel
- Principal Investigator Email
- tomasz_wrobel@wp.pl
- Contact Person Name
- Tomasz Wrobel
- Contact Person Email
- tomasz_wrobel@wp.pl
- Site Name
- Aidport Sp. z o.o.
- Principal Investigator Name
- Michał Kwiatek
- Principal Investigator Email
- michal.kwiatek@aidport.pl
- Contact Person Name
- Michał Kwiatek
- Contact Person Email
- michal.kwiatek@aidport.pl
- Site Name
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
- Department Name
- Oddział Hamatologii Ogólnej i Chorób Wewnętrznych
- Principal Investigator Name
- Tadeusz Robak
- Principal Investigator Email
- robaktad@csk.umed.lodz.pl
- Contact Person Name
- Tadeusz Robak
- Contact Person Email
- robaktad@csk.umed.lodz.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Hematologii i Transplantologii
- Principal Investigator Name
- Magdalena Dutka
- Principal Investigator Email
- dmag77@gumed.edu.pl
- Contact Person Name
- Magdalena Dutka
- Contact Person Email
- dmag77@gumed.edu.pl
- Site Name
- Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
- Department Name
- Oddział Hematologii i Transplantacji Szpiku
- Principal Investigator Name
- Adam Walter-Croneck
- Principal Investigator Email
- awalter@cozl.pl
- Contact Person Name
- Adam Walter-Croneck
- Contact Person Email
- awalter@cozl.pl
Portugal
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 12-06-2024
- Processing Time Days
- 9
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Champalimaud Clinical Centre
- Department Name
- Hemato-Oncology
- Principal Investigator Name
- Cristina Joao
- Principal Investigator Email
- cristina.joao@fundacaochampalimaud.pt
- Contact Person Name
- Cristina Joao
- Contact Person Email
- cristina.joao@fundacaochampalimaud.pt
- Site Name
- Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
- Department Name
- Hematology
- Principal Investigator Name
- María Gomes da Silva
- Principal Investigator Email
- mgsilva@ipolisboa.min-saude.pt
- Contact Person Name
- María Gomes da Silva
- Contact Person Email
- mgsilva@ipolisboa.min-saude.pt
France
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 12-06-2024
- Processing Time Days
- 9
- Number Of Sites
- 11
- Number Of Participants
- 28
Sites
- Site Name
- Groupement Des Hopitaux De L'Institut Catholique De Lille
- Department Name
- Hématologie option maladies du sang
- Principal Investigator Name
- Sandy AMORIM
- Principal Investigator Email
- amorim.sandy@ghicl.net
- Contact Person Name
- Sandy AMORIM
- Contact Person Email
- amorim.sandy@ghicl.net
- Site Name
- Centre Henri Becquerel
- Department Name
- Médecine générale et maladies du sang
- Principal Investigator Name
- Hervé TILLY
- Principal Investigator Email
- herve.tilly@chb.unicancer.fr
- Contact Person Name
- Hervé TILLY
- Contact Person Email
- herve.tilly@chb.unicancer.fr
- Site Name
- Institut Bergonie
- Department Name
- Fontanet
- Principal Investigator Name
- Fontanet BIJOU
- Principal Investigator Email
- f.bijou@bordeaux.unicancer.fr
- Contact Person Name
- Fontanet BIJOU
- Contact Person Email
- f.bijou@bordeaux.unicancer.fr
- Site Name
- Centre Hospitalier Regional Universitaire De Tours
- Department Name
- Hématologie
- Principal Investigator Name
- Caroline DARTIGEAS
- Principal Investigator Email
- c.dartigeas@chu-tours.fr
- Contact Person Name
- Caroline DARTIGEAS
- Contact Person Email
- c.dartigeas@chu-tours.fr
- Site Name
- Centre Hospitalier Universitaire De Poitiers
- Department Name
- Hématologie
- Principal Investigator Name
- Vincent DELWAIL
- Principal Investigator Email
- v.delwail@chu-poitiers.fr
- Contact Person Name
- Vincent DELWAIL
- Contact Person Email
- v.delwail@chu-poitiers.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Hématologie option maladies du sang
- Principal Investigator Name
- Violaine SAFAR
- Principal Investigator Email
- violaine.safar@chu-lyon.fr
- Contact Person Name
- Violaine SAFAR
- Contact Person Email
- violaine.safar@chu-lyon.fr
- Site Name
- CHRU De Nancy
- Department Name
- Médecine interne
- Principal Investigator Name
- Pierre FEUGIER
- Principal Investigator Email
- p.feugier@chru-nancy.fr
- Contact Person Name
- Pierre FEUGIER
- Contact Person Email
- p.feugier@chru-nancy.fr
- Site Name
- Institut Curie
- Department Name
- Oncologie option médicale
- Principal Investigator Name
- Carole SOUSSAIN
- Principal Investigator Email
- carole.soussain@curie.fr
- Contact Person Name
- Carole SOUSSAIN
- Contact Person Email
- carole.soussain@curie.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Biologie Médicale
- Principal Investigator Name
- Kamal-Krimo BOUABDALLAH
- Principal Investigator Email
- krimo.bouabdallah@chu-bordeaux.fr
- Contact Person Name
- Kamal-Krimo BOUABDALLAH
- Contact Person Email
- krimo.bouabdallah@chu-bordeaux.fr
- Site Name
- Hopital Universitaire Pitie Salpetriere
- Department Name
- Hématologie
- Principal Investigator Name
- Véronique MOREL
- Principal Investigator Email
- veronique.morel@psl.aphp.fr
- Contact Person Name
- Véronique MOREL
- Contact Person Email
- veronique.morel@psl.aphp.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Hématologie
- Principal Investigator Name
- Thomas GASTINNE
- Principal Investigator Email
- thomas.gastinne@chu-nantes.fr
- Contact Person Name
- Thomas GASTINNE
- Contact Person Email
- thomas.gastinne@chu-nantes.fr
Belgium
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 13-06-2024
- Processing Time Days
- 10
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Hematology
- Principal Investigator Name
- Fritz Offner
- Principal Investigator Email
- fritz.offner@uzgent.be
- Contact Person Name
- Fritz Offner
- Contact Person Email
- fritz.offner@uzgent.be
- Site Name
- UZ Leuven
- Department Name
- Hematology
- Principal Investigator Name
- Vibeke Vergote
- Principal Investigator Email
- vibeke.vergote@uzleuven.be
- Contact Person Name
- Vibeke Vergote
- Contact Person Email
- vibeke.vergote@uzleuven.be
Denmark
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 12-06-2024
- Processing Time Days
- 9
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Odense University Hospital
- Department Name
- Department of Hematology
- Principal Investigator Name
- Jacob Christensen
- Principal Investigator Email
- jacob.h.christensen@rsyd.dk
- Contact Person Name
- Jacob Christensen
- Contact Person Email
- jacob.h.christensen@rsyd.dk
- Site Name
- Aarhus Universitetshospital
- Department Name
- Department of Hematology
- Principal Investigator Name
- Hans Bentzen
- Principal Investigator Email
- hansbent@rm.dk
- Contact Person Name
- Hans Bentzen
- Contact Person Email
- hansbent@rm.dk
Austria
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 17-06-2024
- Processing Time Days
- 14
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Ordensklinikum Linz GmbH
- Department Name
- Interne 1 - Hämatologie mit Stammzelltransplantation, Hämostaseologie und medizinische Onkologie
- Principal Investigator Name
- Olga Stiefel
- Principal Investigator Email
- olga.stiefel@ordensklinikum.at
- Contact Person Name
- Olga Stiefel
- Contact Person Email
- olga.stiefel@ordensklinikum.at
- Site Name
- SCRI CCCIT Ges.m.b.H.
- Department Name
- Universitätsklinik für Innere Medizin III der PMU
- Principal Investigator Name
- Thomas Melchardt
- Principal Investigator Email
- t.melchardt@salk.at
- Contact Person Name
- Thomas Melchardt
- Contact Person Email
- t.melchardt@salk.at
Germany
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 13-06-2024
- Processing Time Days
- 10
- Number Of Sites
- 3
- Number Of Participants
- 11
Sites
- Site Name
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
- Department Name
- III.Medizinische Klinik und Poliklinik
- Principal Investigator Name
- Georg Hess
- Principal Investigator Email
- georg.hess@unimedizin-mainz.de
- Contact Person Name
- Georg Hess
- Contact Person Email
- georg.hess@unimedizin-mainz.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Medizinische Klinik und Poliklinik III
- Principal Investigator Name
- Martin Dreyling
- Principal Investigator Email
- martin.dreyling@med.uni-muenchen.de
- Contact Person Name
- Martin Dreyling
- Contact Person Email
- martin.dreyling@med.uni-muenchen.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Klinik für Innere Medizin III
- Principal Investigator Name
- Stephan Stilgenbauer
- Principal Investigator Email
- stephan.stilgenbauer@uniklinik-ulm.de
- Contact Person Name
- Stephan Stilgenbauer
- Contact Person Email
- stephan.stilgenbauer@uniklinik-ulm.de
Czechia
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 13-06-2024
- Processing Time Days
- 10
- Number Of Sites
- 2
- Number Of Participants
- 17
Sites
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- The 4th Department of Internal Medicine – Hematology
- Principal Investigator Name
- David Belada
- Principal Investigator Email
- david.belada@seznam.cz
- Contact Person Name
- David Belada
- Contact Person Email
- david.belada@seznam.cz
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Internal hematology and oncology clinic
- Principal Investigator Name
- David Šálek
- Principal Investigator Email
- salek.david@fnbrno.cz
- Contact Person Name
- David Šálek
- Contact Person Email
- salek.david@fnbrno.cz
Spain
- Earliest CTIS Part Ii Submission Date
- 03-06-2024
- Latest Decision Or Authorization Date
- 13-06-2024
- Processing Time Days
- 10
- Number Of Sites
- 12
- Number Of Participants
- 23
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Hematologia
- Principal Investigator Name
- Raúl Córdoba Mascuñano
- Principal Investigator Email
- raul.cordoba@fjd.es
- Contact Person Name
- Raúl Córdoba Mascuñano
- Contact Person Email
- raul.cordoba@fjd.es
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Hematologia
- Principal Investigator Name
- Ana Saus Carreres
- Principal Investigator Email
- saus_ana@gva.es
- Contact Person Name
- Ana Saus Carreres
- Contact Person Email
- saus_ana@gva.es
- Site Name
- University Hospital Son Espases
- Department Name
- Hematologia
- Principal Investigator Name
- Antonio Manuel Guitiérrez García
- Principal Investigator Email
- antoniom.gutierrez@ssib.es
- Contact Person Name
- Antonio Manuel Guitiérrez García
- Contact Person Email
- antoniom.gutierrez@ssib.es
- Site Name
- Hospital Universitario Virgen De La Victoria
- Department Name
- Hematologia
- Principal Investigator Name
- Antonio Rueda Dominguez
- Principal Investigator Email
- rueda.dominguez@gmail.com
- Contact Person Name
- Antonio Rueda Dominguez
- Contact Person Email
- rueda.dominguez@gmail.com
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Hematologia
- Principal Investigator Name
- Adrian Mosquera Orgueira
- Principal Investigator Email
- adrian.mosquera.orgeira@sergas.es
- Contact Person Name
- Adrian Mosquera Orgueira
- Contact Person Email
- adrian.mosquera.orgeira@sergas.es
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Hematologia
- Principal Investigator Name
- Eva Giné Soca
- Principal Investigator Email
- egine@clinic.cat
- Contact Person Name
- Eva Giné Soca
- Contact Person Email
- egine@clinic.cat
- Site Name
- Hospital Universitario Infanta Leonor
- Department Name
- hematologia
- Principal Investigator Name
- Jóse Ángel Hernández Rivas
- Principal Investigator Email
- jahernandezr@salud.madrid.org
- Contact Person Name
- Jóse Ángel Hernández Rivas
- Contact Person Email
- jahernandezr@salud.madrid.org
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Hematología
- Principal Investigator Name
- Carlos Grande García
- Principal Investigator Email
- cgrandeg@unav.es
- Contact Person Name
- Carlos Grande García
- Contact Person Email
- cgrandeg@unav.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Hematologia
- Principal Investigator Name
- Ana Jiménez Ubieto
- Principal Investigator Email
- anitiju@hotmail.com
- Contact Person Name
- Ana Jiménez Ubieto
- Contact Person Email
- anitiju@hotmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Hematologia
- Principal Investigator Name
- Ana Marín Niebla
- Principal Investigator Email
- amarin@vhio.net
- Contact Person Name
- Ana Marín Niebla
- Contact Person Email
- amarin@vhio.net
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Hematología
- Principal Investigator Name
- Mariana Bastos Oreiro
- Principal Investigator Email
- marianabeatriz.bastos@salud.madrid.org
- Contact Person Name
- Mariana Bastos Oreiro
- Contact Person Email
- marianabeatriz.bastos@salud.madrid.org
- Site Name
- Hospital Universitario Son Espases (additional/other site listed)
- Department Name
- Hematologia
- Principal Investigator Name
- Antonio M. Guitiérrez García
- Principal Investigator Email
- antoniom.gutierrez@ssib.es
- Contact Person Name
- Antonio M. Guitiérrez García
- Contact Person Email
- antoniom.gutierrez@ssib.es
Sponsor
Primary sponsor
- Full Name
- Loxo Oncology Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- Clinical operations and multiple sponsor duties (codes present in record)
- Name
- Q Squared Solutions Limited
- Responsibilities
- Clinical/technical support (coded duties)
- Name
- Perceptive Eclinical Limited
- Responsibilities
- Medical imaging analysis
Third parties
- {"country":"United States","full_name":"Unisphere Travel Ltd. Inc.","duties_or_roles":"Patient travel assistance","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"Long term storage","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Alturas Analytics Inc.","duties_or_roles":"Sample storage","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Perceptive Eclinical Limited","duties_or_roles":"Medical Imaging Analysis","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Long term sample storage","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eli Lilly & Co.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Cellcarta Naperville LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- PIRTOBRUTINIB
- Active Substance
- PIRTOBRUTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Orphan Designation
- Yes
- Maximum Dose
- 200 mg (max daily dose listed in product entry)
- Investigational Product Name
- IBRUTINIB
- Active Substance
- IBRUTINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL USE
- Route
- ORAL
- Maximum Dose
- 560 mg (max daily dose listed in product entry)
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