Clinical trial • Phase III • Haematology

GIVINOSTAT for Polycythaemia vera|JAK2V617F-positive polycythaemia vera|High-risk polycythaemia vera

Phase III trial of GIVINOSTAT for Polycythaemia vera|JAK2V617F-positive polycythaemia vera|High-risk polycythaemia vera.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Polycythaemia vera|JAK2V617F-positive polycythaemia vera|High-risk polycythaemia vera
Trial Stage
Phase III
Drug Modality
Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
29-11-2023
First CTIS Authorization Date
27-03-2024

Trial design

Randomised, open-label, hydroxyurea (hydroxycarbamide) - oral comparator arm; product entry indicates up to 3 g/day (maxdailydoseamount 3 g); dosage is optimized/titrated per protocol criteria.-controlled, crossover, adaptive Phase III trial in Bulgaria, Ireland, Austria and others.

Randomised
Yes
Open Label
Yes
Comparator
Hydroxyurea (hydroxycarbamide) - oral comparator arm; product entry indicates up to 3 g/day (maxDailyDoseAmount 3 g); dosage is optimized/titrated per protocol criteria.
Adaptive
Yes
Crossover
Yes
Target Sample Size
74
Trial Duration For Participant
336

Eligibility

Recruits 74 No vulnerable populations selected (isVulnerablePopulationSelected=false). All participants must be able to provide informed consent and sign an ICF. Separate consent documents are provided for optional genetic testing and for pregnant partners (subject information and ICFs listed in documents). Participants are adults (≥18 years)..

Pregnancy Exclusion
Pregnant or nursing (lactating) women
Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected=false). All participants must be able to provide informed consent and sign an ICF. Separate consent documents are provided for optional genetic testing and for pregnant partners (subject information and ICFs listed in documents). Participants are adults (≥18 years).

Inclusion criteria

  • {"criterion_text":"- To be eligible in the core treatment phase: 1. Patients must be able to provide informed consent and be willing to sign an ICF. 2. Patients must be 18 years of age or older. 3. Patients must have a diagnosis of PV confirmed according to the 2016 WHO criteria before randomization. 4. Patients must have JAK2V617F-positive disease. 5. Patients with PV must meet the definition for high risk of thrombosis within 3 years before screening (i.e., age > 60 years or prior thrombosis) 6. Patients must be in need of treatment at screening. 7. Patients must have normalized HCT (i.e., HCT < 45%) at randomization. 8. Patients must have an ECOG performance status ≤ 2 at screening."}
  • {"criterion_text":"- 9. Patients must have a peripheral blood blast count of 0% at screening. 10. Female patients must be either postmenopausal, sterilized or, if of childbearing potential and sexually active, effectively practicing a highly effective method of contraception 11. Female patients of childbearing potential must agree to use highly effective contraception during the study and for at least 6 months after the last dose of study treatment if the patient received hydroxyurea. 12. Male patients must use condoms and ensure that they or their female partner(s) use a highly effective method of contraception as described above during the study and for at least 1 year after the last dose of study treatment if the patient received hydroxyurea 13. Male patients must be willing not to donate sperm during the study and for at least 1 year following the last study drug administration if the patient received hydroxyurea. 14. Patients must be willing and capable to comply with the requirements of the study. Please refer to Protocol, section 5.2 for detailed list of Inclusion criteria."}
  • {"criterion_text":"- To be eligible in the extended treatment phase: 1. Patients must be able to provide informed consent and willing to sign an ICF."}
  • {"criterion_text":"- 2. Patients must have completed the Week 48 visit of the DSC/08/2357/32 core treatment phase."}
  • {"criterion_text":"- 3. Female patients must be either postmenopausal, sterilized or, if of childbearing potential and sexually active, effectively practicing a highly effective method of contraception."}
  • {"criterion_text":"- 4. Female patients of childbearing potential must agree to continue to use highly effective contraception during the extended treatment phase."}
  • {"criterion_text":"- 5. Male patients must continue to use condoms and ensure that they or their female partner(s) continue to use a highly effective method of contraception during the extended treatment phase."}
  • {"criterion_text":"- 6. Male patients must be willing not to donate sperm during the extended treatment phase."}
  • {"criterion_text":"- 7. Patients must be willing and capable to comply with the requirements of the study. Please refer to Protocol, section 5.2 for detailed list of Inclusion criteria"}

Exclusion criteria

  • {"criterion_text":"- 1. Patients pre-treated with HU with a documented history of resistance or intolerance to HU. 2. Patients with clinically significant bacterial, fungal, parasitic or viral infection that requires treatment 3. Patients with a positive test for hepatitis B virus surface antigen, hepatitis C virus antibodies (anti-HCV) or human immunodeficiency virus (HIV) antibodies at screening. 4. Patients diagnosed with primary immunodeficiency syndromes, e.g., X-linked agammaglobulinemia and common variable immune deficiency. 5. Patients with a QTcF value of > 450 msec for males and > 460 msec for females at the Screening visit (as the mean of 3 consecutive readings 5 minutes apart in the event a first ECG demonstrates a prolonged QTcF interval); congenital or acquired history of QTc prolongation or ventricular arrhythmias, at the Screening visit. 6. Patients with clinically significant cardiovascular disease, including uncontrolled hypertension, New York Heart Association Grade III or greater congestive heart failure, torsades de pointes (TdP) and hypokalemia at screening. 7. Patients with myocardial infarction, stroke or unstable angina within the 6 months prior to screening. 8. Splanchnic thrombosis and/or thrombosis of the cerebral venous sinuses and/or splenectomy in the medical history. 9. Patients with inadequate liver or renal function at screening."}
  • {"criterion_text":"- 7. Patients with a QTcF value at Week 48 of > 450 msec for males and > 460 msec for females confirmed by central reading; congenital or acquired history of QTc prolongation or ventricular arrhythmias, at Week 48."}
  • {"criterion_text":"- 8. Being either resistant or intolerant to HU. Please refer to Protocol, section 5.3 for detailed list of exclusion criteria"}
  • {"criterion_text":"- 10. PLT count ≤ 150 × 109/L at screening (test may be repeated once). 11. ANC < 1.2 × 109/L at screening (test may be repeated once). 12. Uncontrolled hypertriglyceridemia at screening, i.e., triglycerides ˃ 1.5 × ULN (test may be repeated once). 13. Presence of other clinically significant disease that, in the Investigator’s opinion, could adversely affect the safety of the patient, making it unlikely that the course of treatment or FU is completed, or could impair the assessment of study results 14. History of major organ transplantation. 15. Patients with documented GI disease that may significantly alter the absorption of oral drugs. 16. Patients with an active malignancy over the 5 years prior to screening, except intraepithelial neoplasia, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, carcinoma in situ of the cervix or early-stage prostate cancer, treated and considered cured"}
  • {"criterion_text":"- 17. Previous treatment with a JAK2 or HDAC inhibitor or 32-phosphorus (radioactive isotope) therapy 18. Patients receiving treatment with interferon or pipobroman within the 5 weeks prior to screening 19. Patients receiving anagrelide within 7 days prior to screening. 20. Patients receiving busulfan or chlorambucil within 2 weeks prior to screening 21. Patients being treated concurrently with any investigational agent or prior participation in an interventional clinical trial within the 30 days prior to screening or within 5 half-lives of the investigational product, whichever is longer 22. Patients with known hypersensitivity to components of the study drugs 23. Pregnant or nursing (lactating) women Please refer to Protocol, section 5.3 for detailed list of exclusion criteria"}
  • {"criterion_text":"- Extended treatment phase: 1. Patients with known hypersensitivity to components of the study drug."}
  • {"criterion_text":"- 2. Pregnant or nursing (lactating) women as assessed at Visit 15."}
  • {"criterion_text":"- 3. Patients with a QTcF value at Week 48 of > 500 msec confirmed by central reading (for patients randomized to givinostat in the core treatment phase)"}
  • {"criterion_text":"- 4. PLT count ≤ 150 × 10^9/L at Week 48 (for patients randomized to HU in the core treatment phase)."}
  • {"criterion_text":"- 5. ANC < 1.2 × 10^9/L at Week 48 (for patients randomized to HU in the core treatment phase)."}
  • {"criterion_text":"- 6. Uncontrolled hypertriglyceridemia at Week 48, i.e., triglycerides ˃ 1.5 × ULN (for patients randomized to HU in the core treatment phase)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Core treatment phase: Proportion of patients achieving a response at Week 48, with response assessment based on: • CHR defined as: HCT < 45% without phlebotomy in the previous 3 months, and WBC count ≤ 10 × 109/L, and PLT count ≤ 400 × 109/L and","definition_or_measurement_approach":"Response assessed at Week 48; CHR defined as HCT < 45% without phlebotomy in previous 3 months, WBC ≤ 10 × 10^9/L, PLT ≤ 400 × 10^9/L."}
  • {"endpoint_text":"- • Normal spleen size as measured by imaging (i.e., MRI - recommended techique, or CT scan). Normal spleen size is defined as: a longitudinal diameter ≤ 12 cm for female and ≤ 13 cm for male, and","definition_or_measurement_approach":"Spleen size measured by imaging (MRI preferred, or CT). Normal spleen size: longitudinal diameter ≤12 cm for female and ≤13 cm for male."}
  • {"endpoint_text":"- • From (Week 25 up to week 48), absence of: progressive disease (as defined in the revised ELN response criteria), major hemorrhagic events (as defined by the International Society on Thrombosis and Haemostasis) and major thrombotic events. Please refer to Protocol, section 3.1 for further details","definition_or_measurement_approach":"Assessed between Week 25 and Week 48; absence of progressive disease per revised ELN criteria and absence of major hemorrhagic events (ISTH definition) and major thrombotic events."}
  • {"endpoint_text":"- Extended treatment phase: • Type, incidence and severity of TEAEs, including SAEs, TEAEs leading to discontinuation or deaths in eligible patients who continued in the extended treatment phase of the DSC/08/2357/32 study.","definition_or_measurement_approach":"Safety/tolerability assessed as type, incidence and severity of treatment-emergent adverse events (TEAEs), including SAEs and TEAEs leading to discontinuation or death in subjects entering the extended treatment phase."}

Secondary endpoints

  • {"endpoint_text":"- Proportion of patients achieving a complete hematological response (CHR) at Week 48 based on: – HCT < 45% without phlebotomy in the previous 3 months, and – White blood cell (WBC) count ≤ 10 × 109/L, and – PLT count ≤ 400 × 109/L Please refer to Protocol, section 3.2 for further details","definition_or_measurement_approach":"CHR at Week 48 defined as HCT <45% without phlebotomy in previous 3 months, WBC ≤ 10 × 10^9/L and PLT ≤ 400 × 10^9/L."}
  • {"endpoint_text":"- Time from randomization to the first observed CHR Please refer to Protocol, section 3.2 for further details","definition_or_measurement_approach":"Time-to-event measure from randomization to first observed CHR (as defined above)."}
  • {"endpoint_text":"- Proportion of patients with a normal spleen size at Week 48","definition_or_measurement_approach":"Spleen size by imaging at Week 48; normal defined as longitudinal diameter ≤12 cm (female) or ≤13 cm (male)."}
  • {"endpoint_text":"- Safety and tolerability. Please refer to Protocol, section 3.2 for further details","definition_or_measurement_approach":"Assessment of adverse events, laboratory assessments, vital signs, ECGs, and related safety measures per protocol."}
  • {"endpoint_text":"- Long-term efficacy evaluated as: - Proportion of patients with a response at yearly assessment visits. - Duration of first CHR. Please refer to Protocol, section 3.2 for further details","definition_or_measurement_approach":"Annual assessments for response; duration measured from first CHR to loss of response or last follow-up."}
  • {"endpoint_text":"- Efficacy evaluated as: - time from randomization to first HCT response without phlebotomy in the previous 3 months; - time from randomization to first WBC response; - time from randomization to first PLT response up to week 48 and in patients with impairment for each parameter at baseline. Please refer to Protocol, section 3.2 for further details.","definition_or_measurement_approach":"Time-to-event analyses for HCT, WBC and PLT responses up to Week 48; assessed in patients with baseline impairment for each parameter."}
  • {"endpoint_text":"- Changes from baseline in physical examination findings, Eastern Cooperative Oncology Group (ECOG) performance status and vital signs, electrocardiograms (ECGs) evaluations, serum chemistry, hematology, serology (if applicable) and urinalysis results. Please refer to Protocol, section 3.2 for further details","definition_or_measurement_approach":"Clinical and laboratory safety endpoints assessed as changes from baseline in physical exam, ECOG, vitals, ECGs, serum chemistry, hematology, serology and urinalysis."}

Recruitment

Planned Sample Size
74
Recruitment Window Months
89
Consent Approach
All participants (adults ≥18) must provide informed consent and sign an ICF. Country- and language-specific ICFs are provided (documents list ICFs in multiple languages including English, German, French, Italian, Spanish, Polish, Hungarian, Bulgarian, Croatian, Dutch, etc.). Separate informed consent forms are provided for optional genetic testing and for pregnant partners; optional consents are explicit in the document listing.

Geography

Total Number Of Sites
55
Total Number Of Participants
219

Bulgaria

Earliest CTIS Part Ii Submission Date
31-03-2024
Latest Decision Or Authorization Date
04-04-2024
Processing Time Days
4
Number Of Sites
3
Number Of Participants
14

Sites

Site Name
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda EAD
Department Name
Clinic of heamatology
Contact Person Name
Liana Gercheva
Contact Person Email
lianagercheva@gmail.com
Site Name
Umbal - Prof. D-R Stoyan Kirkovich AD
Department Name
Department of Clinical Hematology
Contact Person Name
Mariya Todorova
Contact Person Email
dr.maria.dtodorova@gmail.com
Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Clinic of Clinical Hematology
Contact Person Name
Pencho Georgiev
Contact Person Email
penchogeorgiev@yahoo.com

Ireland

Earliest CTIS Part Ii Submission Date
20-03-2024
Latest Decision Or Authorization Date
05-04-2024
Processing Time Days
16
Number Of Sites
2
Number Of Participants
13

Sites

Site Name
Mater Misericordiae University Hospital
Department Name
Haematology
Contact Person Name
Anne Fortune
Contact Person Email
afortune@mater.ie
Site Name
Cork University Hospital
Department Name
Haematology
Contact Person Name
Clodagh Keohane
Contact Person Email
ckeohane@muh.ie

Austria

Earliest CTIS Part Ii Submission Date
13-03-2024
Latest Decision Or Authorization Date
08-04-2024
Processing Time Days
26
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
Noe LGA Gesundheit Thermenregion GmbH
Department Name
Department of Internal medicine Hematology and Internal Oncology
Contact Person Name
Verena Felsleitner-Hauer
Site Name
Medical University Of Vienna
Department Name
Department of Medicine I, Division of Hematology and Hemostaseology
Contact Person Name
Maria Krauth
Contact Person Email
maria.krauth@meduniwien.ac.at
Site Name
Klinikum Wels-Grieskirchen GmbH
Department Name
Department of internal medicine IV
Contact Person Name
Sonja Heibl
Contact Person Email
sonja.heibl@klinikum-wegr.at
Site Name
Ordensklinikum Linz GmbH
Department Name
Department of Hematology with stem cell transplantation, hemostaseology and medical oncology
Contact Person Name
Veronika Buxhofer-Ausch

France

Earliest CTIS Part Ii Submission Date
12-03-2024
Latest Decision Or Authorization Date
05-04-2024
Processing Time Days
24
Number Of Sites
8
Number Of Participants
32

Sites

Site Name
Centre Hospitalier Victor Dupouy
Department Name
Service d‘Hématologie
Contact Person Name
Annalisa ANDREOLI
Site Name
Hopital Saint Louis
Department Name
Centre d’Investigation Clinique
Contact Person Name
Jean-Jacques KILADJIAN
Contact Person Email
jean-jacques.kiladjian@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Département d‘Hématologie
Contact Person Name
Michael LOSCHI
Contact Person Email
loschi.m@chu-nice.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Centre Hospitalier Universitaire d’Angers
Contact Person Name
Françoise BOYER-PERRARD
Contact Person Email
frboyer-perrard@chu-angers.fr
Site Name
Centre Hospitalier De Saint-Quentin
Department Name
Service Oncologie-Hématologie
Contact Person Name
Réda GARIDI
Contact Person Email
r.garidi@ch-stquentin.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Service d’Hématologie et Thérapie Cellulaire
Contact Person Name
Antoine MACHET
Contact Person Email
a.machet@chu-tours.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Service d’Hématologie Clinique et Thérapie Cellulaire
Contact Person Name
Etienne PAUBELLE
Contact Person Email
paubelle.etienne@chu-amiens.fr
Site Name
Centre Hospitalier De Troyes
Department Name
Département d’Hématologie clinique
Contact Person Name
Alberto SANTAGOSTINO

Hungary

Earliest CTIS Part Ii Submission Date
15-03-2024
Latest Decision Or Authorization Date
28-03-2024
Processing Time Days
13
Number Of Sites
3
Number Of Participants
14

Sites

Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
II. Belgyógyászat - Haematológia
Contact Person Name
Eszter Sári
Contact Person Email
sarieszter@gmail.com
Site Name
Tolna Varmegyei Balassa Janos Korhaz
Department Name
Hematológia osztály
Contact Person Name
Renáta Csalódi
Contact Person Email
csalodi.renata@tmkorhaz.hu
Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department Name
Hematológia
Contact Person Name
László Rejtő
Contact Person Email
dr.rejto.laszlo@szszbmk.hu

Italy

Earliest CTIS Part Ii Submission Date
25-03-2024
Latest Decision Or Authorization Date
04-04-2024
Processing Time Days
10
Number Of Sites
16
Number Of Participants
60

Sites

Site Name
Azienda Ospedaliera Papa Giovanni XXIII
Department Name
Unità Operativa Complessa di Ematologia
Contact Person Name
Federico Lussana
Contact Person Email
flussana@asst-pg23.it
Site Name
Azienda Ospedaliero Universitaria Policlinico G Rodolico San Marco Di Catania
Department Name
UO di Ematologia con Trapianto di Midollo Osseo
Contact Person Name
Giuseppe Palumbo
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Ematologia
Contact Person Name
Francesca Palandri
Contact Person Email
francesca.palandri@unibo.it
Site Name
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone
Department Name
Ematologia
Contact Person Name
Marco Santoro
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
Medicina Interna, SOD Clinica Ematologica
Contact Person Name
Serena Rupoli
Site Name
Azienda Ospedaliera Santa Croce E Carle
Department Name
Ematologia
Contact Person Name
Davide Rapezzi
Contact Person Email
rapezzi.d@ospedale.cuneo.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Ematologia
Contact Person Name
Alessandra Iurlo
Site Name
Careggi University Hospital
Department Name
Ematologia
Contact Person Name
Paola Guglielmelli
Contact Person Email
paola.guglielmelli@unifi.it
Site Name
Fondazione Policlinico Universitario Campus Bio-Medico
Department Name
UOC di Ematologia e Trapianto di Cellule Staminali
Contact Person Name
Elisabetta Cerchiara
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
Ematologia
Contact Person Name
Alessia Tieghi
Contact Person Email
alessia.tieghi@ausl.re.it
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
Dipartimento Medico Specialistico ed Oncologico- Ematologia
Contact Person Name
Andrea Patriarca
Contact Person Email
andrea.patriarca@uniupo.it
Site Name
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Department Name
Dipartimento di Oncologia, S.C. di Ematologia
Contact Person Name
Giulia Benevolo
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Dipartimento di Oncologia ed Ematologia Clinica e Sperimentale - SSDB Gruppo di Patologia Ematologia
Contact Person Name
Alessandro Lucchesi
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
U.O. Ematologia e Trapianto di Cellule Staminali
Contact Person Name
Paolo DiTonno
Contact Person Email
p.ditonno@oncologico.bari.it
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
SOC Clinica Ematologica
Contact Person Name
Mario Tiribelli
Contact Person Email
mario.tiribelli@uniud.it
Site Name
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Department Name
UOC Ematologia
Contact Person Name
Caterina Alati
Contact Person Email
caterina.alati@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
11-03-2024
Latest Decision Or Authorization Date
28-03-2024
Processing Time Days
17
Number Of Sites
3
Number Of Participants
14

Sites

Site Name
OncoResearch Lerchenfeld GmbH
Contact Person Name
Thomas Wolff
Site Name
Universitaetsklinikum Halle (Saale) AöR
Department Name
Klinik für Innere Medizin IV
Contact Person Name
Haifa Kathrin Al-Ali
Contact Person Email
haifa.al-ali@uk-halle.de
Site Name
Gemeinschaftspraxis Haematologie Onkologie
Contact Person Name
Thomas Illmer
Contact Person Email
Illmer@onkologie-dresden.net

Spain

Earliest CTIS Part Ii Submission Date
21-03-2024
Latest Decision Or Authorization Date
27-03-2024
Processing Time Days
6
Number Of Sites
6
Number Of Participants
20

Sites

Site Name
Hospital General Universitario Dr. Balmis
Department Name
Hematology
Contact Person Name
Maria del Carmen García Hernández
Contact Person Email
garcia_mcar@gva.es
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Hematology
Contact Person Name
Elvira Mora Castera
Contact Person Email
mora_elv@gva.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Hematology
Contact Person Name
Jose Garcia Gutierrez
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Hematology
Contact Person Name
Regina Garcia-Delgado
Contact Person Email
reginagarciadel@yahoo.es
Site Name
Hospital Germans Trias I Pujol
Department Name
Clinical Hematology
Contact Person Name
Blanca Xicoy Cirici
Site Name
Hospital Universitario Ramon Y Cajal (additional listed site entries aggregated)

Croatia

Earliest CTIS Part Ii Submission Date
12-03-2024
Latest Decision Or Authorization Date
04-04-2024
Processing Time Days
23
Number Of Sites
4
Number Of Participants
14

Sites

Site Name
General Hospital Sibenik
Department Name
Hematology
Contact Person Name
Ivan Krecak
Contact Person Email
ivan.krecak@bolnica-sibenik.hr
Site Name
Clinical Hospital Dubrava
Department Name
Hematology
Contact Person Name
Marko Lucijanic
Contact Person Email
markolucijanic@yahoo.com
Site Name
Clinical Hospital Centre Rijeka
Department Name
Hematology
Contact Person Name
Dragana Grohovac
Contact Person Email
dzdrijeka@gmail.com
Site Name
KBC Zagreb
Department Name
Hematology
Contact Person Name
Drazen Pulanic
Contact Person Email
dpulanic@yahoo.com

Poland

Earliest CTIS Part Ii Submission Date
25-03-2024
Latest Decision Or Authorization Date
02-04-2024
Processing Time Days
8
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Indywidualna Specjalistyczna Praktyka Lekarska Tomasz Wozny
Contact Person Name
Tomasz Woźny
Site Name
Specjalistyczny Szpital Im. Dra Alfreda Sokolowskiego
Department Name
Oddzial Hematologiczny
Contact Person Name
Aleksandra Butrym
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych
Contact Person Name
Tomasz Wróbel
Contact Person Email
tomasz_wrobel@wp.pl

Netherlands

Earliest CTIS Part Ii Submission Date
11-03-2024
Latest Decision Or Authorization Date
08-04-2024
Processing Time Days
28
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Medisch Spectrum Twente
Department Name
Internal medicine/haematology/oncology
Contact Person Name
Marie-Cecile Legdeur
Contact Person Email
m.legdeur@mst.nl
Site Name
Spaarne Gasthuis
Department Name
Internal medicine/haematology/oncology
Contact Person Name
Aart Beeker
Contact Person Email
abeeker@spaarnegasthuis.nl
Site Name
Albert Schweitzer Ziekenhuis
Department Name
Internal medicine/haematology/oncology
Contact Person Name
Peter Westerweel
Contact Person Email
p.e.westerweel@asz.nl

Sponsor

Primary sponsor

Full Name
Italfarmaco S.p.A.
Organisation Type
Pharmaceutical company
Country Of Registered Address
Italy

Contract research organisations

Name
Eresearchtechnology Inc.
Responsibilities
Central Safety Reader for ECG data
Name
4g Clinical LLC
Responsibilities
sponsorDuties codes: 3
Name
Syneos Health Inc.
Responsibilities
sponsorDuties codes: 4
Name
Medidata Solutions Inc.
Responsibilities
sponsorDuties codes: 7
Name
Bioclinica Inc.
Responsibilities
Central Reader for Imaging
Name
PPD Development LP
Responsibilities
sponsorDuties codes: 1,11,12,13,14,2,5,8
Name
Alira Health S.r.l.
Responsibilities
sponsorDuties codes: 6

Third parties

  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Central Safety Reader for ECG data","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties codes: 3","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Molecular Pathology Laboratory Network Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Italy","full_name":"Careggi University Hospital","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: 7","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Salvius Legal B.V.","duties_or_roles":"legal review of site contracts","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Central Reader for Imaging","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"sponsorDuties codes: 1,11,12,13,14,2,5,8","organisation_type":"Pharmaceutical company"}
  • {"country":"Italy","full_name":"Alira Health S.r.l.","duties_or_roles":"sponsorDuties codes: 6","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Givinostat 50 mg capsules
Active Substance
GIVINOSTAT
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Not approved in any country worldwide
Orphan Designation
Yes
Dose Levels
50 mg
Maximum Dose
100 mg/day
Investigational Product Name
Givinostat 75 mg capsules
Active Substance
GIVINOSTAT
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Not approved in any country worldwide
Orphan Designation
Yes
Dose Levels
75 mg
Maximum Dose
150 mg/day
Investigational Product Name
Givinostat 100 mg capsules
Active Substance
GIVINOSTAT
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Not approved in any country worldwide
Orphan Designation
Yes
Dose Levels
100 mg
Maximum Dose
200 mg/day
Investigational Product Name
HYDROXYCARBAMIDE
Active Substance
HYDROXYCARBAMIDE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Maximum Dose
3 g/day

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