Clinical trial • Phase III • Oncology|Cardiology

PACRITINIB for Primary myelofibrosis | Post-polycythaemia vera myelofibrosis | Post-essential thrombocythaemia myelofibrosis

Phase III trial of PACRITINIB for Primary myelofibrosis | Post-polycythaemia vera myelofibrosis | Post-essential thrombocythaemia myelofibrosis.

Overview

Trial Therapeutic Area
Oncology|Cardiology
Trial Disease
Primary myelofibrosis | Post-polycythaemia vera myelofibrosis | Post-essential thrombocythaemia myelofibrosis
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
01-10-2024
First CTIS Authorization Date
08-11-2024

Trial design

Randomised, open-label, physician choice therapy (single agent selected prior to randomization). the physician choice options (selected prior to randomization) include corticosteroids (e.g., methylprednisolone — product listing shows oral methylprednisolone with max daily dose 360 mg), prednisone/prednisolone (oral, max daily dose 60 mg), dexamethasone (oral, max daily dose 10 mg), hydroxycarbamide (oral, listed with dosing up to 80 mg/kg/day in product metadata), danazol (oral, max daily dose 800 mg), and low‑dose ruxolitinib (oral, product metadata lists up to 50 mg/day). the proposed physician choice regimen for a patient must be selected prior to randomization.-controlled Phase III trial in Czechia, Poland, France and others.

Randomised
Yes
Open Label
Yes
Comparator
Physician Choice therapy (single agent selected prior to randomization). The Physician Choice options (selected prior to randomization) include corticosteroids (e.g., methylprednisolone — product listing shows oral methylprednisolone with max daily dose 360 mg), prednisone/prednisolone (oral, max daily dose 60 mg), dexamethasone (oral, max daily dose 10 mg), hydroxycarbamide (oral, listed with dosing up to 80 mg/kg/day in product metadata), danazol (oral, max daily dose 800 mg), and low‑dose ruxolitinib (oral, product metadata lists up to 50 mg/day). The proposed Physician Choice regimen for a patient must be selected prior to randomization.
Target Sample Size
192
Trial Duration For Participant
913

Stratification factors

  • prior JAK2 inhibitor therapy (yes/no)
  • Physician Choice therapy selected prior to randomization

Eligibility

Recruits 192 The protocol excludes several vulnerable groups: "Persons deprived of their liberty by a judicial or administrative decision"; "Persons subject to legal protection measures or unable to express their consent"; and "Temporarily incapacitated persons". Participation requires provision of signed informed consent by the participant (Inclusion criterion: "16. Provision of signed informed consent"). Age eligibility is ≥18 years, so no paediatric assent procedures are described. (Vulnerable-population exclusions and consent requirement are taken directly from the cited eligibility criteria.).

Pregnancy Exclusion
25. Women who are pregnant or lactating
Vulnerable Population
The protocol excludes several vulnerable groups: "Persons deprived of their liberty by a judicial or administrative decision"; "Persons subject to legal protection measures or unable to express their consent"; and "Temporarily incapacitated persons". Participation requires provision of signed informed consent by the participant (Inclusion criterion: "16. Provision of signed informed consent"). Age eligibility is ≥18 years, so no paediatric assent procedures are described. (Vulnerable-population exclusions and consent requirement are taken directly from the cited eligibility criteria.)

Inclusion criteria

  • {"criterion_text":"- 1. Primary MF, post-polycythemia vera MF, or post-essential thrombocythemia MF\n- 10. Left ventricular cardiac ejection fraction of ≥50% by echocardiogram or multigated acquisition scan\n- 11. Adequate liver and renal function, defined by liver transaminases (aspartate aminotransferase [AST]/serum glutamic-oxaloacetic transaminase [SGOT] and alanine aminotransferase [ALT]/serum glutamic pyruvic transaminase [SGPT]) ≤3 × the upper limit of normal (ULN) (AST/ALT ≤5 × ULN if transaminase elevation is related to MF), total bilirubin ≤4 × ULN (in cases where total bilirubin is elevated, direct bilirubin ≤4 × ULN is required), and creatinine ≤2.5 mg/dL\n- 12. Adequate coagulation defined by prothrombin time/international normalized ratio and partial thromboplastin time ≤1.5 × ULN\n- 13. If fertile, willing to use highly effective birth control methods during the study\n- 14. Willing to undergo and able to tolerate frequent MRI or CT scan assessments during the study\n- 15. Able to understand and willing to complete symptom assessments using a patient-reported outcome instrument\n- 16. Provision of signed informed consent\n- 2. Platelet count of <50,000/μL at Screening (Day -35 to Day -3)\n- 3. Dynamic International Prognostic Scoring System Intermediate-1, Intermediate-2, or High-Risk\n- 4. Palpable splenomegaly ≥5 cm below the lower costal margin in the midclavicular line as assessed by physical examination\n- 5. TSS of ≥10 on the MPN-SAF TSS 2.0 or a single symptom score of ≥5 or two symptoms of ≥3, including only the symptoms of left upper quadrant pain, bone pain, itching, or night sweats. The TSS criteria need only to be met on a single day\n- 6. Age ≥18 years\n- 7. Eastern Cooperative Oncology Group performance status 0 to 2\n- 8. Peripheral blast count of <10% throughout the Screening period prior to randomization\n- 9. Absolute neutrophil count of ≥500/μL"}

Exclusion criteria

  • {"criterion_text":"- 1. Life expectancy <6 months\n- 10. Treatment with an experimental therapy, including MF-directed experimental therapies within 28 days prior to treatment Day 1\n- 11. Systemic treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor or a strong CYP3A4 inducer within 14 days prior to treatment Day 1. Shorter washout periods may be permitted with approval of the Medical Monitor, provided that the washout period is at least five half-lives of the drug prior to treatment Day 1\n- 12. Significant recent bleeding history defined as National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grade ≥2 within 3 months prior to treatment Day 1, unless precipitated by an inciting event (eg, surgery, trauma, or injury)\n- 13. Systemic treatment with medications that increase the risk of bleeding, including anticoagulants, antiplatelet agents (except for aspirin dosages of ≤100 mg per day), and daily use of cyclooxygenase-1 (COX-1) inhibiting non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to treatment Day 1. Treatment with systemic anti-vascular endothelial growth factor (anti-VEGF) agents within 28 days prior to treatment Day 1.\n- 14. Systemic treatment with medications that can prolong the QT interval within 14 days prior to treatment Day 1. Shorter washout periods may be permitted with approval of the Medical Monitor, provided that the washout period is at least five half-lives of the drug prior to treatment Day 1\n- 15. Any history of CTCAE grade ≥2 non-dysrhythmia cardiac conditions within 6 months prior to treatment Day 1. Patients with asymptomatic grade 2 non-dysrhythmia cardiovascular conditions may be considered for inclusion, with the approval of the Medical Monitor, if stable and unlikely to affect patient safety\n- 16. Any history of CTCAE grade ≥2 cardiac dysrhythmias within 6 months prior to treatment Day 1. Patients with non-corrected QT interval CTCAE grade 2 cardiac dysrhythmias may be considered for inclusion, with the approval of the Medical Monitor, if the dysrhythmias are stable, asymptomatic, and unlikely to affect patient safety\n- 17. QT corrected by the Fridericia method (QTcF) prolongation >450 ms or other factors that increase the risk for QT interval prolongation (eg, hypokalemia [defined as serum potassium <3.0 mEq/L that is persistent and refractory to correction], or history of long QT interval syndrome)\n- 18. New York Heart Association Class II, III, or IV congestive heart failure\n- 19. Any active gastrointestinal or metabolic condition that could interfere with absorption of oral medication\n- 2. Completed allogeneic stem cell transplant, or are eligible for and willing to complete other approved available therapy including allogeneic stem cell transplant\n- 20. Active or uncontrolled inflammatory or chronic functional bowel disorder such as Crohn’s Disease, inflammatory bowel disease, chronic diarrhea, or chronic constipation\n- 21. Other malignancy within 3 years prior to treatment Day 1. The following patients may be eligible despite having had a malignancy within the prior 3 years: patients with curatively treated squamous or basal cell carcinoma of the skin; patients with curatively treated non-invasive cancers; patients with organ-confined prostate cancer with prostate specific antigen (PSA) <20 ng/mL and National Comprehensive Cancer Network risk of Very Low, Low, or Favorable Intermediate; and patients with curatively treated non-metastatic prostate cancer with negative PSA\n- 22. Uncontrolled intercurrent illness, including, but not limited to, ongoing active infection, psychiatric illness, or social situation that, in the judgment of the treating physician, would limit compliance with trial requirements\n- 23. Known seropositivity for human immunodeficiency (HIV) virus. For patients in Czech Republic, France, and Italy only: testing for HIV is required during Screening\n- 24. Known active hepatitis A, B, or C virus infection. For patients in Czech Republic, France, and Italy only: testing for hepatitis B and C is required during Screening\n- 25. Women who are pregnant or lactating\n- 26. Concurrent enrollment in another interventional trial\n- 27. Severe thrombocytopenia due to vitamin B12 deficiency, folate deficiency, or viral infection in the opinion of the investigator\n- 28. Known hypersensitivity to pacritinib or any of the following inactive ingredients: microcrystalline cellulose, polyethylene glycol, and magnesium stearate; any contraindication to the “physician’s choice” medicinal product selected by the investigator to be used as the comparator or to loperamide or equivalent antidiarrheal medication\n- 29. Persons deprived of their liberty by a judicial or administrative decision\n- 3. History of splenectomy or planning to undergo splenectomy\n- 30. Persons subject to legal protection measures or unable to express their consent\n- 31. Temporarily incapacitated persons\n- 4. Splenic irradiation within the last 6 months\n- 5. Previously treated with pacritinib\n- 6. Treatment with any MF-directed therapy within 14 days prior to treatment Day 1\n- 7. Prior treatment with more than one JAK2 inhibitor\n- 8. Prior treatment with ruxolitinib, if BOTH of the following conditions are met: i. exposure to higher-dose ruxolitinib (>10 mg daily) within 120 days prior to treatment Day 1; AND ii. total duration of treatment with higher-dose ruxolitinib (>10 mg daily) was >90 days, from first to last exposure (i.e., this 90-day period starts on the date of first administration of ruxolitinib at a total daily dose of >10 mg and continues for 90 calendar days, regardless of whether higher-dose ruxolitinib is administered continuously or intermittently\n- 9. Prior treatment with any JAK2 inhibitor other than ruxolitinib, irrespective of dose, with a duration of >90 days. The 90-day period starts on the date of first administration of JAK2 inhibitor therapy and continues for 90 calendar days, regardless of whether therapy is administered continuously or intermittently"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Percentage of patients who achieve at least 35% reduction in spleen volume from baseline as measured by MRI (preferred) or CT scan at Week 24.","definition_or_measurement_approach":"Spleen volume reduction ≥35% from baseline at Week 24 measured by magnetic resonance imaging (MRI; preferred) or computed tomography (CT) scan."}
  • {"endpoint_text":"- 2. Percentage of patients with at least 50% reduction in TSS from baseline at Week 24 (as defined by the Myeloproliferative Neoplasm Symptom Assessment Form [MPN‐SAF TSS 2.0] excluding the “tiredness” component)","definition_or_measurement_approach":"Reduction ≥50% in Total Symptom Score (TSS) from baseline at Week 24 as defined by the MPN‑SAF TSS 2.0 instrument, excluding the 'tiredness' component."}

Secondary endpoints

  • {"endpoint_text":"- 1. Percentage of patients who self-assess as “very much improved” or “much improved” at Week 24","definition_or_measurement_approach":"Patient Global Impression of Change (PGIC) self-assessment at Week 24; proportion reporting 'very much improved' or 'much improved'."}
  • {"endpoint_text":"- 2. Time from randomization to the date of death due to any cause","definition_or_measurement_approach":"Overall survival measured as time (days) from date of randomization to date of death from any cause."}
  • {"endpoint_text":"- 3. Incidence and severity of TEAEs, including SAEs and deaths, as well as laboratory values and vital signs, including cardiac evaluations from the time of randomization until 30 days after completion of treatment with pacritinib and/or physician's choice therapy","definition_or_measurement_approach":"Safety assessments including treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), deaths, laboratory tests, vital signs, and cardiac evaluations collected from randomization until 30 days after treatment completion."}

Recruitment

Planned Sample Size
192
Recruitment Window Months
94
Consent Approach
Signed informed consent is required from each participant (Inclusion criterion: "16. Provision of signed informed consent"). Participant information and informed consent documents (L1_SIS and ICF) are provided in multiple country/language-specific versions (document list includes English, Hungarian, Czech, Polish, French, Italian, Spanish, Bulgarian, Romanian versions and associated addenda for genetic testing and pregnant partner). No paediatric assent is described because the study requires Age ≥18 years.

Geography

Total Number Of Sites
57
Total Number Of Participants
207

Czechia

Latest Decision Or Authorization Date
11-11-2024
Number Of Sites
4
Number Of Participants
8

Sites

Site Name
Fakultni Nemocnice Plzen
Department Name
Hemato-Oncology
Principal Investigator Name
Pavel Jindra
Principal Investigator Email
jindra@fnplzen.cz
Contact Person Name
Pavel Jindra
Contact Person Email
jindra@fnplzen.cz
Site Name
University Hospital Olomouc
Department Name
Hemato-oncology
Principal Investigator Name
Antonin Hlusi
Principal Investigator Email
hematologie@fnol.cz
Contact Person Name
Antonin Hlusi
Contact Person Email
hematologie@fnol.cz
Site Name
Fakultni Nemocnice Kralovske Vinohrady
Department Name
Clinic of Internal Hematology
Principal Investigator Name
Olga Cerna
Principal Investigator Email
olga.cerna@fnkv.cz
Contact Person Name
Olga Cerna
Contact Person Email
olga.cerna@fnkv.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Clinic of Internal Medicine - Hematology and Oncology
Principal Investigator Name
Libor Cervinek
Principal Investigator Email
Cervinek.libor@fnbrno.cz
Contact Person Name
Libor Cervinek
Contact Person Email
Cervinek.libor@fnbrno.cz

Poland

Latest Decision Or Authorization Date
24-11-2024
Number Of Sites
12
Number Of Participants
50

Sites

Site Name
Uniwersytecki Szpital Kliniczny W Bialymstoku
Department Name
Klinika Hematologii, Chorób Wew. i Angiologii z Pododdziałem Transplantacji Komórek Krwiotwórczych
Principal Investigator Name
Jarosław Piszcz
Principal Investigator Email
hem@umwb.edu.pl
Contact Person Name
Jarosław Piszcz
Contact Person Email
hem@umwb.edu.pl
Site Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Department Name
Oddział Hematologii Ogólnej i Chorób Wewnętrznych
Principal Investigator Name
Jacek Treliński
Principal Investigator Email
szpital@kopernik.lodz.pl
Contact Person Name
Jacek Treliński
Contact Person Email
szpital@kopernik.lodz.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name
Oddział Kliniczny Hematologii i Chorób Wewnętrznych
Principal Investigator Name
Tomasz Sacha
Principal Investigator Email
hematologiasekretariat@su.krakow.pl
Contact Person Name
Tomasz Sacha
Site Name
Instytut Hematologii I Transfuzjologii
Department Name
Klinika Hematologii; Onkologiczne Centrum Wsparcia Badań Klinicznych
Principal Investigator Name
Ewa Lech-Marańda
Principal Investigator Email
sekihit@ihit.waw.pl
Contact Person Name
Ewa Lech-Marańda
Contact Person Email
sekihit@ihit.waw.pl
Site Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych
Principal Investigator Name
Tomasz Wróbel
Principal Investigator Email
khn@usk.wroc.pl
Contact Person Name
Tomasz Wróbel
Contact Person Email
khn@usk.wroc.pl
Site Name
Samodzielny Publiczny Szpital Kliniczny Im.Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego W Katowicach
Department Name
Oddział Hematologii i Transplantacji Szpiku Ul. Dąbrowskiego 25, 40-032 Katowice
Principal Investigator Name
Patrycja Zielińska
Principal Investigator Email
spskm@spskm.katowice.pl
Contact Person Name
Patrycja Zielińska
Contact Person Email
spskm@spskm.katowice.pl
Site Name
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Department Name
Oddział Hematoonkologii, Transplantacji Szpiku i Chemioterapii
Principal Investigator Name
Maria Soroka-Wojtaszko
Principal Investigator Email
szpital@usk1.pl
Contact Person Name
Maria Soroka-Wojtaszko
Contact Person Email
szpital@usk1.pl
Site Name
Szpital Specjalistyczny Im. Jedrzeja Sniadeckiego W Nowym Saczu SPZOZ
Department Name
Oddział Hematologiczny
Principal Investigator Name
Szymon Fornagiel
Principal Investigator Email
ho@szpitalnowysacz.pl
Contact Person Name
Szymon Fornagiel
Contact Person Email
ho@szpitalnowysacz.pl
Site Name
Pratia Hematologia Sp. z o.o.
Department Name
Pratia Onkologia Katowice
Principal Investigator Name
Sebastian Grosicki
Principal Investigator Email
anna.jakubiec@pratia.com
Contact Person Name
Sebastian Grosicki
Contact Person Email
anna.jakubiec@pratia.com
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Hematologii i Transplantologii ul. M. Smoluchowskiego 17, 80-214 Gdansk
Principal Investigator Name
Jan Zaucha
Principal Investigator Email
info@uck.gda.pl
Contact Person Name
Jan Zaucha
Contact Person Email
info@uck.gda.pl
Site Name
Medicover Integrated Clinical Services Sp. z o.o.
Department Name
MICS Centrum Medyczne Toruń
Principal Investigator Name
Marcin Rymko
Principal Investigator Email
batorego@naszlekarz.pl
Contact Person Name
Marcin Rymko
Contact Person Email
batorego@naszlekarz.pl
Site Name
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
Department Name
Klinika Hematologii
Principal Investigator Name
Marta Sobas
Principal Investigator Email
Marta.Sobas@gmail.com
Contact Person Name
Marta Sobas
Contact Person Email
Marta.Sobas@gmail.com

France

Latest Decision Or Authorization Date
08-11-2024
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
Hospices Civils De Lyon
Department Name
Lyon Sud Hospital, Department of Hematology
Principal Investigator Name
Fiorenza Barraco
Principal Investigator Email
fiorenza.barraco@chu-lyon.fr
Contact Person Name
Fiorenza Barraco
Contact Person Email
fiorenza.barraco@chu-lyon.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Miletrie Hospital, Department of Hematology
Principal Investigator Name
Jose Miguel Torregrosa-Diaz
Contact Person Name
Jose Miguel Torregrosa-Diaz
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Saint Louis Hospital, Department of Hematology
Principal Investigator Name
Jean-Jacques Kiladjian
Principal Investigator Email
jean-jacques.kiladjian@aphp.fr
Contact Person Name
Jean-Jacques Kiladjian
Contact Person Email
jean-jacques.kiladjian@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Caremeau Site, Department of Hematology
Principal Investigator Name
Stefan Wickenhauser
Principal Investigator Email
stefan.wickenhauser@chu-nimes.fr
Contact Person Name
Stefan Wickenhauser
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Department of Hematology
Principal Investigator Name
Clemence Mediavilla
Principal Investigator Email
Clemence.Mediavilla@chu-bordeaux.fr
Contact Person Name
Clemence Mediavilla

Italy

Latest Decision Or Authorization Date
13-11-2024
Number Of Sites
15
Number Of Participants
65

Sites

Site Name
Careggi University Hospital
Department Name
Dept of Hematology
Principal Investigator Name
Alessandro Vannucchi
Principal Investigator Email
studiclinici-emato@sc-saluteumana.unifi.it
Contact Person Name
Alessandro Vannucchi
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
Complex Operative Unit of Hematology and Cellular Therapy
Principal Investigator Name
Paolo Ditonno
Principal Investigator Email
p.ditonno@oncologico.bari.it
Contact Person Name
Paolo Ditonno
Contact Person Email
p.ditonno@oncologico.bari.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Dept of Hematology
Principal Investigator Name
Massimo Breccia
Principal Investigator Email
massimo.breccia@uniroma1.it
Contact Person Name
Massimo Breccia
Contact Person Email
massimo.breccia@uniroma1.it
Site Name
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Department Name
Oncological Hematology Operational Unit
Principal Investigator Name
Caterina Patti
Principal Investigator Email
k.patti@villasofia.it
Contact Person Name
Caterina Patti
Contact Person Email
k.patti@villasofia.it
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
Dept Of Hematology
Principal Investigator Name
Andrea Patriarca
Principal Investigator Email
andrea.patriarca@uniupo.it
Contact Person Name
Andrea Patriarca
Contact Person Email
andrea.patriarca@uniupo.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Dept of Medical Oncology
Principal Investigator Name
Alessandro Lucchesi
Principal Investigator Email
alessandro.lucchesi@irst.emr.it
Contact Person Name
Alessandro Lucchesi
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Dept of Hematology
Principal Investigator Name
Fabrizio Pane
Principal Investigator Email
fabrizio.pane@unina.it
Contact Person Name
Fabrizio Pane
Contact Person Email
fabrizio.pane@unina.it
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
hematological Clinic
Principal Investigator Name
Mario Tiribelli
Principal Investigator Email
mario.tiribelli@uniud.it
Contact Person Name
Mario Tiribelli
Contact Person Email
mario.tiribelli@uniud.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
Dept of Hematology
Principal Investigator Name
Alessandra Iurlo
Principal Investigator Email
alessandra.iurlo@policlinico.mi.it
Contact Person Name
Alessandra Iurlo
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Dept Of Hematology
Principal Investigator Name
Francesca Palandri
Principal Investigator Email
francesca.palandri@unibo.it
Contact Person Name
Francesca Palandri
Contact Person Email
francesca.palandri@unibo.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
Dept of Hematology
Principal Investigator Name
Domenico Russo
Principal Investigator Email
domenico.russo@unibs.it
Contact Person Name
Domenico Russo
Contact Person Email
domenico.russo@unibs.it
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Department of Radiological and Hematological Sciences
Principal Investigator Name
Valerio De Stefano
Principal Investigator Email
Valerio.DeStefano@unicatt.it
Contact Person Name
Valerio De Stefano
Contact Person Email
Valerio.DeStefano@unicatt.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Dept of Hematology
Principal Investigator Name
Giulia Benevolo
Principal Investigator Email
gbenevolo@cittadellasalute.to.it
Contact Person Name
Giulia Benevolo
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Dept of Hematology
Principal Investigator Name
Elena Maria Elli
Principal Investigator Email
elenamaria.elli@irccs-sangerardo.it
Contact Person Name
Elena Maria Elli
Site Name
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
Department Name
Complex Structure of Hematology
Principal Investigator Name
Marco Brociner
Principal Investigator Email
marco.brociner@asst-settelaghi.it
Contact Person Name
Marco Brociner

Spain

Latest Decision Or Authorization Date
12-11-2024
Number Of Sites
9
Number Of Participants
20

Sites

Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Hematology
Principal Investigator Name
Jose Valentin Garcia Gutierrez
Principal Investigator Email
jvalentingg@gmail.com
Contact Person Name
Jose Valentin Garcia Gutierrez
Contact Person Email
jvalentingg@gmail.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Hematology
Principal Investigator Name
Rosa Ayala Diaz
Principal Investigator Email
rayaladiaz@yahoo.es
Contact Person Name
Rosa Ayala Diaz
Contact Person Email
rayaladiaz@yahoo.es
Site Name
Hospital Universitario De Salamanca
Department Name
Hematology
Principal Investigator Name
Jesus Maria Hernandez Rivas
Principal Investigator Email
jmhr@usal.es
Contact Person Name
Jesus Maria Hernandez Rivas
Contact Person Email
jmhr@usal.es
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Hematology
Principal Investigator Name
Maria Isabel Montero Cuadrado
Principal Investigator Email
icas3760@hotmail.com
Contact Person Name
Maria Isabel Montero Cuadrado
Contact Person Email
icas3760@hotmail.com
Site Name
Hospital Clinic De Barcelona
Department Name
Hematology
Principal Investigator Name
Alberto Alvarez Larran
Principal Investigator Email
aalvar@clinic.cat
Contact Person Name
Alberto Alvarez Larran
Contact Person Email
aalvar@clinic.cat
Site Name
Hospital Del Mar
Department Name
Hematology
Principal Investigator Name
Patricia Velez Tenza
Principal Investigator Email
patricia.velez.tenza@psmar.cat
Contact Person Name
Patricia Velez Tenza
Contact Person Email
patricia.velez.tenza@psmar.cat
Site Name
Hospital General Universitario Morales Meseguer
Department Name
Hematology and Hemotherapy
Principal Investigator Name
Carlos Bravo-Perez
Principal Investigator Email
carlos.bravo@carm.es
Contact Person Name
Carlos Bravo-Perez
Contact Person Email
carlos.bravo@carm.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Hematology
Principal Investigator Name
Maria Laura Fox
Principal Investigator Email
mlfox@vhio.net
Contact Person Name
Maria Laura Fox
Contact Person Email
mlfox@vhio.net
Site Name
Universitat De Valencia
Department Name
Hematology and Medical Oncology
Principal Investigator Name
Juan Carlos Hernandez-Boluda
Principal Investigator Email
hernandez_jca@gva.es
Contact Person Name
Juan Carlos Hernandez-Boluda
Contact Person Email
hernandez_jca@gva.es

Hungary

Latest Decision Or Authorization Date
08-11-2024
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department Name
Department of Hematology
Principal Investigator Name
Laszlo Szerafin
Principal Investigator Email
dr.szerafin.laszlo@szszbmk.hu
Contact Person Name
Laszlo Szerafin
Contact Person Email
dr.szerafin.laszlo@szszbmk.hu
Site Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Department Name
Department of Haematology
Principal Investigator Name
Miklos Egyed
Principal Investigator Email
egyed.miklos@kmmk.hu
Contact Person Name
Miklos Egyed
Contact Person Email
egyed.miklos@kmmk.hu
Site Name
Fejer Varmegyei Szent Gyoergy Egyetemi Oktato Korhaz
Department Name
Department of Internal Medicine III, Hematology
Principal Investigator Name
Arpad Szomor
Principal Investigator Email
info@mail.fmkorhaz.hu
Contact Person Name
Arpad Szomor
Contact Person Email
info@mail.fmkorhaz.hu
Site Name
University Of Debrecen
Department Name
Clinic of Internal Medicine, Department of Hematology
Principal Investigator Name
Arpad Illes
Principal Investigator Email
illes.arpad@med.unideb.hu
Contact Person Name
Arpad Illes
Contact Person Email
illes.arpad@med.unideb.hu

Bulgaria

Latest Decision Or Authorization Date
11-11-2024
Number Of Sites
5
Number Of Participants
20

Sites

Site Name
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Department Name
Clinical Hematology Clinic
Principal Investigator Name
Doroteya Todorieva-Todorova
Principal Investigator Email
umbal@umbalpln.com
Contact Person Name
Doroteya Todorieva-Todorova
Contact Person Email
umbal@umbalpln.com
Site Name
National Specialised Hospital For Active Treatment Of Haematological Diseases
Department Name
Clinical Hematology Clinic
Principal Investigator Name
Tihomir Zhivkov
Principal Investigator Email
tihomir.zhivkov@abv.bg
Contact Person Name
Tihomir Zhivkov
Contact Person Email
tihomir.zhivkov@abv.bg
Site Name
University Hospital St Marina Varna
Department Name
Clinical Hematology Clinic
Principal Investigator Name
Vladimir Gerov
Principal Investigator Email
office@svetamarina.com
Contact Person Name
Vladimir Gerov
Contact Person Email
office@svetamarina.com
Site Name
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Department Name
Clinical Hematology Clinic
Principal Investigator Name
Zhanet Grudeva-Popova
Principal Investigator Email
unihosp@unihosp.com
Contact Person Name
Zhanet Grudeva-Popova
Contact Person Email
unihosp@unihosp.com
Site Name
Military Medical Academy
Department Name
Hematology Clinic
Principal Investigator Name
Viktoria Barbukova
Principal Investigator Email
vma@vma.bg
Contact Person Name
Viktoria Barbukova
Contact Person Email
vma@vma.bg

Romania

Latest Decision Or Authorization Date
27-11-2024
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
Department of Hematology
Principal Investigator Name
Ionut Ciprian Tomuleasa
Principal Investigator Email
ciprian.tomuleasa@gmail.com
Contact Person Name
Ionut Ciprian Tomuleasa
Contact Person Email
ciprian.tomuleasa@gmail.com
Site Name
Institutul Clinic Fundeni
Department Name
Department of Hematology and Bone Marrow Transplantation Center
Principal Investigator Name
Daniel Coriu
Principal Investigator Email
daniel_coriu@yahoo.com
Contact Person Name
Daniel Coriu
Contact Person Email
daniel_coriu@yahoo.com
Site Name
Spitalul Clinic Coltea
Department Name
Department of Hematology
Principal Investigator Name
Gabriela Borsaru
Principal Investigator Email
gabriex2001@yahoo.it
Contact Person Name
Gabriela Borsaru
Contact Person Email
gabriex2001@yahoo.it
Site Name
Onco Card S.R.L.
Department Name
Department of Hematology
Principal Investigator Name
Mihaela Cornelia Lazaroiu
Principal Investigator Email
ellalaz@yahoo.com
Contact Person Name
Mihaela Cornelia Lazaroiu
Contact Person Email
ellalaz@yahoo.com

Sponsor

Primary sponsor

Full Name
Sobi Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Parexel International Corporation
Responsibilities
Medical image analysis/ review - X-ray, MRI, ultrasound,
Name
Rho Inc.
Responsibilities
10
Name
Almac Clinical Services LLC
Responsibilities
3
Name
WCG Clinical Inc.
Responsibilities
10
Name
Medidata Solutions Inc.
Responsibilities
10

Third parties

  • {"country":"United States","full_name":"Parexel International Corporation","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound,","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"10","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Rho Inc.","duties_or_roles":"10","organisation_type":"Pharmaceutical company"}
  • {"country":"Czechia","full_name":"Quinta-Analytica s.r.o.","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Myriad RBM Inc.","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"eResearchTechnology, Inc. (eRT)","duties_or_roles":"ePRO","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Biodesix Inc.","duties_or_roles":"4","organisation_type":"Industry"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"10","organisation_type":"Pharmaceutical company"}
  • {"country":"Russian Federation","full_name":"Psi Company Ltd.","duties_or_roles":"Project Management","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Imaging (ECG)","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"3","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"10","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Myriad RBM Inc.","duties_or_roles":"4","organisation_type":"Laboratory/Research/Testing facility"}

Investigational products

Investigational Product Name
Pacritinib
Active Substance
PACRITINIB
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Authorisation Status
Authorised
Starting Dose
200 mg twice a day
Dose Levels
200 mg twice daily
Frequency
Twice a day
Maximum Dose
400 mg/day

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