Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
549
Countries
11
Sites
54
Mantle cell lymphoma
To compare progression-free survival (PFS) of pirtobrutinib as monotherapy (Arm A) to Investigator choice of covalent Bruton’s tyrosine kinase (BTK) inhibitor monotherapy (Arm B) in patients with previously treated Mantle Cell Lymphoma (MCL)
Key facts
- Sponsor
- Loxo Oncology Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 Mar 2021 → ongoing
- Decision date (initial)
- 2024-06-17
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Loxo Oncology, Inc., a wholly owned subsidiary of Eli Lilly and Company
External identifiers
- EU CT number
- 2023-507695-52-00
- EudraCT number
- 2020-004553-72
- WHO UTN
- U1111-1300-4821
- ClinicalTrials.gov
- NCT04662255
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety, Pharmacokinetic, Pharmacogenomic
To compare progression-free survival (PFS) of pirtobrutinib as monotherapy (Arm A) to Investigator choice of covalent Bruton’s tyrosine kinase (BTK) inhibitor monotherapy (Arm B) in patients with previously treated Mantle Cell Lymphoma (MCL)
Conditions and MedDRA coding
Mantle cell lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10026799 | Mantle cell lymphoma NOS | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 10
- Confirmed Mantle Cell Lymphoma (MCL) diagnosis
- Previously treated with at least one prior line of systemic therapy for MCL
- Measurable disease per Lugano criteria
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Absolute neutrophil count ≥ 0.75 × 109/L without granulocyte-colony stimulating factor support within 7 days of screening
- Hemoglobin ≥ 8 g/dL not requiring transfusion support or growth factors within 7 days of screening
- Platelets ≥ 50 × 109/L not requiring transfusion support or growth factors within 7 days of screening.
- AST and ALT ≤ 3.0 x upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 x ULN.
- Creatinine clearance of ≥ 30 mL/min according to Cockcroft/Gault Formula
Exclusion criteria 11
- Prior treatment with an approved or investigational BTK inhibitor
- 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
- Clinically significant cardiovascular disease
- 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
- Known HIV infection or active HBV, HCV, or CMV infections. (Certain participants with controlled HBV infections may still be eligible)
- Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal (GI) absorption
- 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.
- Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.
- Vaccination with live vaccine within 28 days prior to randomization
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Assessed by independent review committee (IRC) • Progression-free survival (PFS) per Lugano criteria
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
SUB215610 · Substance
- Active substance
- Pirtobrutinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 292000 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/21/2450
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary relabeling to occur to comply with EU labelling requirements
SUB215610 · Substance
- Active substance
- Pirtobrutinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 292000 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/21/2450
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary relabeling to occur to comply with EU labeling requirements
PRD10892568 · Product
- Active substance
- Pirtobrutinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 292000 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- ELI LILLY AND COMPANY LIMITED
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/21/2450
Comparator 2
SUB120863 · Substance
- Active substance
- Ibrutinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 560 mg milligram(s)
- Max total dose
- 817600 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary relabeling to occur to comply with EU labeling requirements
SUB120863 · Substance
- Active substance
- Ibrutinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 560 mg milligram(s)
- Max total dose
- 817600 mg milligram(s)
- Max treatment duration
- 48 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Secondary relabeling to occur to comply with EU labeling requirements
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Loxo Oncology Inc.
- Sponsor organisation
- Loxo Oncology Inc.
- Address
- 281 Tresser Boulevard Floor 9th
- City
- Stamford
- Postcode
- 06901-3238
- Country
- United States
Scientific contact point
- Organisation
- Loxo Oncology Inc.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Loxo Oncology Inc.
- Contact name
- Lilly Clinical Trials information desk
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| Infinity Biologix LLC ORG-100040369
|
Piscataway, United States | Other, Laboratory analysis |
| Eli Lilly & Co. ORG-100000156
|
Indianapolis, United States | Code 8 |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 12, Code 2, Code 5, Data management, E-data capture |
| Cellcarta Naperville LLC ORG-100042145
|
Naperville, United States | Laboratory analysis |
| Perceptive Eclinical Limited ORG-100041144
|
Nottingham, United Kingdom | Other |
| Alturas Analytics Inc. ORG-100045347
|
Moscow, United States | Other, Laboratory analysis |
| Iqvia Laboratories Limited ORG-100042527
|
Reading, United Kingdom | Laboratory analysis |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
| Unisphere Travel Ltd. Inc. ORG-100043100
|
Norwood, United States | Other |
Locations
11 EU/EEA countries · 54 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 9 | 2 |
| Belgium | Ongoing, recruitment ended | 5 | 2 |
| Czechia | Ongoing, recruitment ended | 17 | 2 |
| Denmark | Ongoing, recruitment ended | 9 | 2 |
| France | Ongoing, recruitment ended | 28 | 11 |
| Germany | Ongoing, recruitment ended | 11 | 3 |
| Italy | Ongoing, recruitment ended | 28 | 10 |
| Netherlands | Ongoing, recruitment ended | 4 | 2 |
| Poland | Ongoing, recruitment ended | 53 | 6 |
| Portugal | Ongoing, recruitment ended | 10 | 2 |
| Spain | Ongoing, recruitment ended | 23 | 12 |
| Rest of world
Japan, Israel, Australia, United States, Taiwan, United Kingdom, New Zealand, Canada, Russian Federation, China, Brazil, Switzerland, Korea, Republic of
|
— | 352 | — |
Investigational sites
SCRI CCCIT Ges.m.b.H.
Universitätsklinik für Innere Medizin III der PMU, Muellner Hauptstrasse 48, 5020, Salzburg
Ordensklinikum Linz GmbH
Interne 1 - Hämatologie mit Stammzelltransplantation, Hämostaseologie und medizinische Onkologie, Fadingerstrasse 1, 4020, Linz
Universitair Ziekenhuis Gent
Hematology, Corneel Heymanslaan 10, 9000, Gent
UZ Leuven
Hematology, Herestraat 49, 3000, Leuven
Fakultni Nemocnice Hradec Kralove
The 4th Department of Internal Medicine – Hematology, Sokolska 581, 500 03, Novy Hradec Kralove
Fakultni Nemocnice Brno
Internal hematology and oncology clinic, Jihlavska 340/20, Bohunice, Brno
Aarhus Universitetshospital
Department of Hematology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Odense University Hospital
Department of Hematology, J B Winsloews Vej 4, 5000, Odense C
Groupement Des Hopitaux De L'Institut Catholique De Lille
Hématologie option maladies du sang, Boulevard De Belfort, P. O. Box 387, Lille Cedex
Centre Hospitalier Universitaire De Poitiers
Hématologie, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Regional Universitaire De Tours
Hématologie, 2 Boulevard Tonnelle, 37000, Tours
Centre Hospitalier Universitaire De Nantes
Hématologie, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Bordeaux
Biologie Médicale, Avenue De Magellan, 33600, Pessac
Hospices Civils De Lyon
Hématologie option maladies du sang, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Institut Bergonie
Fontanet, 180 R De Saint Genes, 229 Cours De L Argonne, Bordeaux
Institut Curie
Oncologie option médicale, 35 Rue Dailly, 92210, Saint-Cloud
Centre Henri Becquerel
Médecine générale et maladies du sang, Rue D Amiens, 76038, Rouen Cedex
CHRU De Nancy
Médecine interne, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Hopital Universitaire Pitie Salpetriere
Hématologie, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Universitaetsklinikum Ulm AöR
Klinik für Innere Medizin III, Albert-Einstein-Allee 23, Eselsberg, Ulm
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
III.Medizinische Klinik und Poliklinik, Langenbeckstrasse 1, Oberstadt, Mainz
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik und Poliklinik III, Marchioninistrasse 15, Hadern, Munich
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
SSD Ematologia e Trapianti CSE, Via Piero Maroncelli 40, 47014, Meldola
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Dipar&mento di Ematologia, Viale Luigi Borri N 57, 21100, Varese
Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo
SC Ematologia, Via Venezia 16, 15121, Alexandria
IRCCS Ospedale Policlinico San Martino
UO Clinica Ematologica, Largo Rosanna Benzi 10, 16132, Genoa
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
U.O.C. Ematologia, Via Pietro Albertoni 15, 40138, Bologna
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
UO Ematologia I, Viale Strasburgo 233, 90146, Palermo
Azienda Unita Sanitaria Locale Della Romagna
UO Oncologia e Ematologia, Via Alcide De Gasperi 8, 48121, Ravenna
Azienda USL IRCCS Di Reggio Emilia
SC Ematologia, Via Giovanni Amendola 2, 42122, Reggio Emilia
Ospedale San Raffaele S.r.l.
Reparto di Oncoematologia, Via Olgettina 60, 20132, Milan
IRCCS Centro Di Riferimento Oncologico Della Basilicata
Ematologia e trapianto di cellule staminali, Via Padre Pio 1, 85028, Rionero In Vulture
Bravis Ziekenhuis
Internal Medicine, Boerhaavelaan 25, 4708 AE, Roosendaal
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Hematology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Oddział Hematologii i Transplantacji Szpiku, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Pratia S.A.
Pratia MCM Krakow, Ul. Pana Tadeusza 2, 30-727, Cracow
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Oddział Hamatologii Ogólnej i Chorób Wewnętrznych, Ul. Pabianicka 62, 93-513, Lodz
Aidport Sp. z o.o.
N/A, Ul Ksiedza Stanisława Kozierowskiego 24, 60-185, Skorzewo
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
Hematology, Rua Professor Lima Basto, 1099-023, Lisbon
Champalimaud Clinical Centre
Hemato-Oncology, Avenida Brasilia S/n, 1400-038, Lisbon
Hospital Universitario Infanta Leonor
hematologia, Avenida Gran Via Del Este 80, 28031, Madrid
Hospital Clinico Universitario De Valencia
Hematologia, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitario 12 De Octubre
Hematologia, Bloque D, Avenida De Cordoba Sn, Madrid
Hospital Universitario Virgen De La Victoria
Hematologia, Calle Del Arroyo Teatinos Sn, 29010, Malaga
Hospital Clinic De Barcelona
Hematologia, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
Hematologia, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
University Hospital Son Espases
Hematologia, Carretera Valldemossa 79, 07120, Palma
Complexo Hospitalario Universitario De Santiago
Hematologia, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Fundacion Jimenez Diaz
Hematologia, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Clinica Universidad De Navarra
Hematología, Avenue Pio XII 36, 31008, Pamplona
Hospital General Universitario Gregorio Maranon
Hematología, Calle Del Doctor Esquerdo 46, 28009, Madrid
Institut Catala D'oncologia
Hematologia, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2021-09-23 | 2021-10-14 | 2023-10-06 | ||
| Belgium | 2021-08-18 | 2021-10-01 | 2023-10-06 | ||
| Czechia | 2021-08-26 | 2021-09-07 | 2023-10-06 | ||
| Denmark | 2021-11-03 | 2022-09-05 | 2023-10-06 | ||
| France | 2021-07-05 | 2021-09-16 | 2023-10-06 | ||
| Germany | 2022-04-15 | 2022-08-09 | 2023-10-06 | ||
| Italy | 2021-10-21 | 2021-12-15 | 2023-10-06 | ||
| Netherlands | 2021-03-05 | 2021-04-08 | 2023-10-06 | ||
| Poland | 2021-10-07 | 2021-11-17 | 2023-10-06 | ||
| Portugal | 2021-03-05 | 2021-04-08 | 2023-10-06 | ||
| Spain | 2021-09-10 | 2021-12-22 | 2023-10-06 |
Oversight and notifications
Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77
Serious breaches 1 · Art. 52 CTR
Serious breach SB-38744
- Sponsor became aware
- 2024-05-31
- Date of breach
- 2023-02-09
- Submission date
- 2024-08-05
- Member states concerned
- Austria, Belgium, Czechia, Denmark, France, Germany, Italy, Portugal, Spain, Netherlands, Poland
- Categories
- Regulation
- Areas impacted
- Subject rights
- Benefit-risk balance changed
- No
- Description
- During the most recent update of the Lilly Pirtobrutinib Risk Profile (RP) document, it was discovered that the known Adverse Drug Reaction (ADR) “skin rash” was inadvertently omitted. This ADR was included in the Pirtobrutinib Investigator Brochure (IB), however, when the RP was updated in February 2023, based on the December 2022 IB, “skin rash” was mistakenly left out.
Since the RP is used to create the Informed Consent Forms (ICF), this omission meant that the risk of “skin rash” was not included in any of the ICFs for the seven ongoing Pirtobrutinib studies. As a result, new and existing patients were not informed about this risk when they consented or re-consented to participate in these trials. - Sponsor actions
- Lilly has initiated a Root Cause Investigation. Sites are in the process of being informed and patients reconsented
| Organisation | City | Country | Type |
|---|---|---|---|
| Fakultni Nemocnice Brno | Brno | Czechia | Clinical facility BE/BA |
| Odense University Hospital | Odense C | Denmark | Clinical facility BE/BA |
| Aarhus Universitetshospital | Aarhus N | Denmark | Clinical facility BE/BA |
| Hopital Universitaire Pitie Salpetriere | Paris Cedex 13 | France | Clinical facility BE/BA |
| Institut Curie | Saint-Cloud | France | Clinical facility BE/BA |
| Hospices Civils De Lyon | Pierre-Benite | France | Clinical facility BE/BA |
| Hospital Universitario 12 De Octubre | Madrid | Spain | Clinical facility BE/BA |
| Hospital Clinic De Barcelona | Barcelona | Spain | Clinical facility BE/BA |
| Hospital Universitario Fundacion Jimenez Diaz | Madrid | Spain | Clinical facility BE/BA |
| Complexo Hospitalario Universitario De Santiago | Santiago De Compostela | Spain | Clinical facility BE/BA |
| Hospital General Universitario Gregorio Maranon | Madrid | Spain | Clinical facility BE/BA |
| Centre Hospitalier Universitaire De Bordeaux | Pessac | France | Clinical facility BE/BA |
| University Hospital Son Espases | Palma | Spain | Clinical facility BE/BA |
| Groupement Des Hopitaux De L'Institut Catholique De Lille | Lille Cedex | France | Clinical facility BE/BA |
| Centre Henri Becquerel | Rouen Cedex | France | Clinical facility BE/BA |
| Institut Bergonie | Bordeaux | France | Clinical facility BE/BA |
| IRCCS Centro Di Riferimento Oncologico Della Basilicata | Rionero In Vulture | Italy | Clinical facility BE/BA |
| CHRU De Nancy | Vandoeuvre Les Nancy | France | Clinical facility BE/BA |
| Ospedale San Raffaele S.r.l. | Milan | Italy | Clinical facility BE/BA |
| Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l. | Meldola | Italy | Clinical facility BE/BA |
| Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico | Bologna | Italy | Clinical facility BE/BA |
| Azienda Unita Sanitaria Locale Della Romagna | Ravenna | Italy | Clinical facility BE/BA |
| Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E. | Lisbon | Portugal | Clinical facility BE/BA |
| Unidade Local De Saude De Santa Maria E.P.E. | Lisbon | Portugal | Clinical facility BE/BA |
| Champalimaud Clinical Centre | Lisbon | Portugal | Clinical facility BE/BA |
| Hospital Clinico Universitario De Valencia | Valencia | Spain | Clinical facility BE/BA |
| Clinica Universidad De Navarra | Pamplona | Spain | Clinical facility BE/BA |
| Hospital Universitario Virgen De La Victoria | Malaga | Spain | Clinical facility BE/BA |
| Institut Catala D'oncologia | L'hospitalet De Llobregat | Spain | Clinical facility BE/BA |
| Hospital Universitario Infanta Leonor | Madrid | Spain | Clinical facility BE/BA |
| Haga Hospital | 's-Gravenhage | Netherlands | Clinical facility BE/BA |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) | Rotterdam | Netherlands | Clinical facility BE/BA |
| Bravis Ziekenhuis | Roosendaal | Netherlands | Clinical facility BE/BA |
| Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu | Wroclaw | Poland | Clinical facility BE/BA |
| Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli | Lublin | Poland | Clinical facility BE/BA |
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi | Lodz | Poland | Clinical facility BE/BA |
| Pratia S.A. | Cracow | Poland | Clinical facility BE/BA |
| Pratia S.A. | Skorzewo | Poland | Clinical facility BE/BA |
| SCRI CCCIT Ges.m.b.H. | Salzburg | Austria | Clinical facility BE/BA |
| Ordensklinikum Linz GmbH | Linz | Austria | Clinical facility BE/BA |
| Centre Hospitalier Universitaire De Nantes | Nantes | France | Clinical facility BE/BA |
| Hospital Universitari Vall D Hebron | Barcelona | Spain | Clinical facility BE/BA |
| Universitair Ziekenhuis Gent | Gent | Belgium | Clinical facility BE/BA |
| Centre Hospitalier Regional Universitaire De Tours | Tours | France | Clinical facility BE/BA |
| Centre Hospitalier Universitaire De Poitiers | Poitiers | France | Clinical facility BE/BA |
| Universitaetsklinikum Ulm AöR | Ulm | Germany | Clinical facility BE/BA |
| Klinikum der Universitaet Muenchen AöR | Munich | Germany | Clinical facility BE/BA |
| Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR | Mainz | Germany | Clinical facility BE/BA |
| Azienda USL IRCCS Di Reggio Emilia | Reggio Emilia | Italy | Clinical facility BE/BA |
| Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello | Palermo | Italy | Clinical facility BE/BA |
| Azienda Socio Sanitaria Territoriale Dei Sette Laghi | Varese | Italy | Clinical facility BE/BA |
| Azienda Ospedaliero-Universitaria Ss Antonio E Biagio E Cesare Arrigo | Alexandria | Italy | Clinical facility BE/BA |
| IRCCS Ospedale Policlinico San Martino | Genoa | Italy | Clinical facility BE/BA |
| Algemeen Ziekenhuis Delta | Roeselare | Belgium | Clinical facility BE/BA |
| UZ Leuven | Leuven | Belgium | Clinical facility BE/BA |
| Fakultni Nemocnice Hradec Kralove | Novy Hradec Kralove | Czechia | Clinical facility BE/BA |
| Uniwersyteckie Centrum Kliniczne | Gdansk | Poland | Clinical facility BE/BA |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 103 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2023-507695-52-00_red_san | 10.0 |
| Protocol (for publication) | D4_Patient facing documents_Copyright statement | N/A |
| Recruitment arrangements (for publication) | K_Recruitment Arrangements and Consent Procedures | 1 |
| Recruitment arrangements (for publication) | K1_2023-507695-52_Recruitment Arrangements_Memo_san | N/A |
| Recruitment arrangements (for publication) | K1_Blank doc for CTIS placeholders for transitional trial_san | N/A |
| Recruitment arrangements (for publication) | K1_LOXO-BTK-20019_Blank doc for CTIS placeholders for end of recruitment | V1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | V1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_Blank_page_san | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | V1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_blank | V1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_blank page_San | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank placeholder_san | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_CEC submission_red_san | N/A |
| Subject information and informed consent form (for publication) | L1_2023-507695-52_ICF Addendum TbDP_san | V3.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2023-507695-52_Main ICF_Red_san | V7.0FRA2.0 |
| Subject information and informed consent form (for publication) | L1_2023-507695-52_Main SOC ICF 1_san | 1-0FRA1-0 |
| Subject information and informed consent form (for publication) | L1_2023-507695-52_Main SOC ICF 2_san | 2-0FRA1-0 |
| Subject information and informed consent form (for publication) | L1_Addendum ICF | V3.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_ICF contact list_red | V4.0 |
| Subject information and informed consent form (for publication) | L1_ICF SOC | V2.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_ICF SOC_TC | V2.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_LOXO-BTK-20019_Addendum ICF_san | V3.0NLD1.0 |
| Subject information and informed consent form (for publication) | L1_LOXO-BTK-20019_Addendum to Main_Clean | V1.0NLD1.0 |
| Subject information and informed consent form (for publication) | L1_LOXO-BTK-20019_Addendum to Main_san | V2.0NLD2.0 |
| Subject information and informed consent form (for publication) | L1_LOXO-BTK-20019_Addendum to Main_TC | V2.0NLD2.0 |
| Subject information and informed consent form (for publication) | L1_LOXO-BTK-20019_Main ICF_red_san | V7.0NLD1.0 |
| Subject information and informed consent form (for publication) | L1_Main ICF_red | V7.0AUT2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and FR ICF_red | V1.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum TbDP_Clean | V1.0DNK3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum TBP | V3.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_red | V3.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Amendment Summary_san | V1.0DEU1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_red | 7.0ESP1.0A |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_redacted | 10.0DNK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Mand PG Tes_red | V1.0PRT2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional PGx IS_red | V1.0PRT2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_red | V1.0PRT2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner | 3.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_red | V1.0PRT2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum TBP_san | V3.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum to Main ICF_PL_san | V3.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Treatment Beyond PD_en_clean | V3.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Treatment Beyond PD_fr_clean | V3.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Treatment Beyond PD_nl_clean | V3.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum_san | 3.0DEU2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Amendment summary_2_san | V2DEUde1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_already enrolled patient_red_san | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_clean_red_san | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_en_clean_red | V7.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_fr_clean_red | V7.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_nl_clean_red | V7.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_PL_redacted | V7.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Summary of Changes ICF_san | V3.0CZE1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Summary_PL_redacted | V1.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main Summary_PL_San | V2.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Red_san | V7.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_red-san | 7DEUde2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SoC2 ICF_Clean | V2.0DNK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_SoC3 ICF_Clean | 3.0DNK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary ICF_red_san | V1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary ICF_San | 2.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes ICF_red | V1.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes Main ICF V1_en_clean_red | V1.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes Main ICF V1_fr_clean_red | V1.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes Main ICF V1_nl_clean_red | V1.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes Main ICF V2_en_clean_san | V2.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes Main ICF V2_fr_clean_san | V2.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes Main ICF V2_nl_clean_san | V2.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes Main ICF V3_en_clean_red | V3.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes Main ICF V3_fr_clean_red | V3.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes Main ICF V3_nl_clean_red | V3.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and Main ICF_red | 10.0PRT1.0 |
| Subject information and informed consent form (for publication) | L1_SoC ICF_red | V2.0AUT1.0 |
| Subject information and informed consent form (for publication) | L1_SoC ICF_Uniklinikum Salzburg_red | V1.0AUT1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Colpitts prepaid Visa Card FAQ | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Patient Study Guide | V03PRT01 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Visit Reminder Card | V01PRT |
| Subject information and informed consent form (for publication) | L2_Other subject information_FSR ICF_clean_red_san | 5.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_FSR ICF_enrolled patients_red_san | 5.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Main GDPR ICF_clean_san | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Main GDPR ICF_enrolled patient_san | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Optional Study ICF_clean_red_san | V5.1CZE1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Optional Study ICF_enrolled patients_red_san | V5.1CZE1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Treatment Beyond Progression ICF_clean_san | 3.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Treatment Beyond Progression ICF_enrolled patients_san | 3.0 |
| Subject information and informed consent form (for publication) | L2_OtherSubInfo_BfS Information_red-san | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Imbruvica_san | na |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis _2023-507695-52-00 _de-BEL | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis _2023-507695-52-00 _fr_BEL | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis _2023-507695-52-00 _nl-BEL | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-507695-52-00_AT-DE_red_san | 3.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-507695-52-00_cs-CZE | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-507695-52-00_CZ_red_san | 3CZE(cs)1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-507695-52-00_de-AT | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-507695-52-00_EN | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-507695-52-00_IT | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-507695-52-00_pl-POL | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2023-507695-52-00_pt_PT | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis _2023-507695-52-00_es-ES | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis _2023-507695-52-00_nl_NL | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_2023-507695-52-00_fr-FRA | 2.0 |
Application history
9 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-29 | Denmark | Acceptable 2024-06-12
|
2024-06-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-09-30 | Denmark | Acceptable 2025-01-20
|
2025-01-21 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-02-12 | Denmark | Acceptable 2025-04-10
|
2025-04-10 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-26 | Denmark | Acceptable 2025-08-29
|
2025-08-29 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-09-30 | Acceptable 2025-08-29
|
2025-09-30 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-10-17 | Acceptable | 2025-10-31 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-10-27 | Acceptable | 2025-11-13 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-10-28 | Acceptable | 2025-11-19 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-8 | 2026-04-07 | Denmark | Acceptable 2026-06-02
|
2026-06-02 |