Clinical trial • Phase II/III • Oncology

NAVTEMADLIN for Primary myelofibrosis | Post-polycythemia vera myelofibrosis | Post-essential thrombocythemia myelofibrosis

Phase II/III trial of NAVTEMADLIN for Primary myelofibrosis | Post-polycythemia vera myelofibrosis | Post-essential thrombocythemia myelofibrosis.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Primary myelofibrosis | Post-polycythemia vera myelofibrosis | Post-essential thrombocythemia myelofibrosis
Trial Stage
Phase II/III
Drug Modality
Small molecule|Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
08-10-2024
First CTIS Authorization Date
14-11-2024

Trial design

Randomised, open-label, best available therapy (comparator arm: physician's choice/best available therapy including approved therapies listed in part i/ii such as danatrol 50 mg capsule, danazol polfarmex 200 mg tablet, lenalidomide accord 5 mg hard capsules, pegasys 180 micrograms solution (peginterferon alfa-2a), prednison 10 mg, hydrea (hydroxycarbamide) 500 mg capsule). doses are as named (e.g., danatrol 50 mg, lenalidomide 5 mg, pegasys 180 micrograms, prednison 10 mg, hydrea 500 mg); scheduling details not specified in ctis record.-controlled Phase II/III trial in Portugal, Romania, Bulgaria and others.

Randomised
Yes
Open Label
Yes
Comparator
Best Available Therapy (comparator arm: physician's choice/best available therapy including approved therapies listed in Part I/II such as Danatrol 50 mg capsule, DANAZOL POLFARMEX 200 mg tablet, Lenalidomide Accord 5 mg hard capsules, Pegasys 180 micrograms solution (peginterferon alfa-2a), Prednison 10 mg, HYDREA (hydroxycarbamide) 500 mg capsule). Doses are as named (e.g., Danatrol 50 mg, Lenalidomide 5 mg, Pegasys 180 micrograms, Prednison 10 mg, HYDREA 500 mg); scheduling details not specified in CTIS record.
Biomarker Stratified
True, TP53 (p53) wild-type (p53WT)
Target Sample Size
194

Eligibility

Recruits 194 adults.

Inclusion criteria

  • {"criterion_text":"- Part A: Adults ≥18 years of age\n- Part B: Failure of prior treatment with JAK inhibitor\n- Part B: ECOG ≤ 2\n- Part A: Confirmed diagnosis of PMF, post-PV MF or post-ET MF (WHO)\n- Part A: High, intermediate-2, or intermediate-1 risk Dynamic International Prognostic System (DIPSS)\n- Part A: Failure of prior treatment with JAK inhibitor\n- Part A: ECOG ≤ 2\n- Part B: Adults >18 years of age\n- Part B: Confirmed diagnosis of PMF, post PV-MF, or post-ET-MF (WHO)\n- Part B: High, intermediate-2, or intermediate-1 risk Dynamic International Prognostic System (DIPSS)\n- Part B: Subjects with p53WT MF by central laboratory testing"}

Exclusion criteria

  • {"criterion_text":"- Part A: Subjects who are positive for P53 mutations\n- Part A: Grade 2 or higher QTc prolongation (> 480 milliseconds per NCI-CTCAE criteria, version 5.0)\n- Part B: Prior splenectomy\n- Part B: Splenic irradiation within 12 weeks of randomization\n- Part B: Prior allogeneic stem-cell transplantation or plans for allogeneic stem cell transplantation\n- Part B: Prior MDM2 inhibitor therapy or p53-directed therapy\n- Part B: JAK-, PI3k-, SYK-, BTK-, BET- or MTOR inhibitor treatment within 28 days prior to the Screening MRI/CT scan\n- Part A: Prior splenectomy\n- Part B: History of major hemorrhage or intracranial hemorrhage within 6 months prior to randomization\n- Part B: History of stroke, reversible ischemic neurological defect or transient ischemic attack within 6 months prior to randomization\n- Part A: Splenic irradiation within 3 months prior to randomization\n- Part A: History of major hemorrhage or intracranial hemorrhage within 6 months prior to randomization\n- Part A: History of stroke, reversible ischemic neurological defect or transient ischemic attack within 6 months prior to randomization\n- Part A: Prior MDM2 inhibitor therapy or p53-directed therapy\n- Part A: Prior allogeneic stem-cell transplant or plans for allogeneic stem cell transplant\n- Part B: History of major organ transplant\n- Part B: Grade 2 or higher QTc prolongation (>480 milliseconds per NCI- CTCAE criteria, version 5.0)\n- Part A: History of major organ transplant"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Part A: The proportion of subjects achieving a ≥35% spleen volume reduction from Baseline to Week 24, as assessed by magnetic resonance imaging (MRI) or computed tomography (CT) scan.","definition_or_measurement_approach":"Spleen volume reduction ≥35% from Baseline to Week 24 measured by MRI or CT scan."}
  • {"endpoint_text":"- Part B: The proportion of subjects in each arm achieving SVR of ≥ 35% at Week 24 by MRI/CT scan (central review)","definition_or_measurement_approach":"Spleen volume reduction (SVR) ≥35% at Week 24 assessed by MRI/CT with central review."}

Secondary endpoints

  • {"endpoint_text":"- Part A: Proportion of subjects with a reduction in total symptom score","definition_or_measurement_approach":"Reduction in modified MPN-SAF Total Symptom Score (TSS) at specified time points (e.g., Week 24, Week 48)."}
  • {"endpoint_text":"- Part A: To determine the duration of reduction of spleen volume","definition_or_measurement_approach":"Duration of spleen volume reduction (time-to-event measure of maintained reduction)."}
  • {"endpoint_text":"- Part A: To determine the need for red blood cell (RBC) transfusion","definition_or_measurement_approach":"Assessment of RBC transfusion usage during study period."}
  • {"endpoint_text":"- Part A: The proportion of subjects who have RBC transfusion independence at week 24","definition_or_measurement_approach":"Proportion of subjects meeting predefined criteria for RBC transfusion independence at Week 24."}
  • {"endpoint_text":"- Part A: To determine complete and partial remission of treated subjects","definition_or_measurement_approach":"Assessment of complete and partial remission per protocol-defined criteria."}
  • {"endpoint_text":"- Part A: To determine time to death from any cause in treated subjects","definition_or_measurement_approach":"Overall survival (time from treatment or randomization to death from any cause)."}
  • {"endpoint_text":"- Part A: To determine the pharmacokinetic/pharmacodynamic (PK/PD) profile of KRT-232","definition_or_measurement_approach":"PK/PD sampling and analysis of KRT-232 in treated subjects."}
  • {"endpoint_text":"- Part B: The proportion of subjects with reduction from Baseline to Week 24 in the total symptom score","definition_or_measurement_approach":"Reduction in modified MPN-SAF Total Symptom Score (TSS) from Baseline to Week 24."}
  • {"endpoint_text":"- Part B: Time from randomization to death from any cause","definition_or_measurement_approach":"Overall survival measured from randomization to death from any cause."}
  • {"endpoint_text":"- Part B: Progression free survival (PFS): time from randomization to either first occurrence of disease progression or death due to any cause","definition_or_measurement_approach":"PFS defined as time from randomization to first documented disease progression or death."}
  • {"endpoint_text":"- Part B: The proportion of subjects in each arm achieving spleen volume reduction","definition_or_measurement_approach":"Proportion achieving predefined spleen volume reduction thresholds (e.g., ≥35%) assessed by MRI/CT."}
  • {"endpoint_text":"- Part B: Time from initial spleen volume reduction until the first occurrence of disease progression","definition_or_measurement_approach":"Time from initial documented spleen volume reduction to disease progression (time-to-event)."}
  • {"endpoint_text":"- Part B: The proportion of subjects who have red blood cell transfusion independence at week 24","definition_or_measurement_approach":"Proportion of subjects meeting protocol-defined RBC transfusion independence criteria at Week 24."}

Recruitment

Planned Sample Size
194
Recruitment Window Months
96
Consent Approach
Informed consent is obtained from adult participants (≥18 years). Country-specific subject information and informed consent forms are provided (multiple languages / country versions present in the CTIS documents list). Participant information sheets are available for adults and for pregnant partners in country-specific versions. No assent procedures for minors are indicated (study enrols adults).

Geography

Total Number Of Sites
51
Total Number Of Participants
253

Portugal

Latest Decision Or Authorization Date
14-11-2024
Number Of Sites
1
Number Of Participants
4

Sites

Site Name
Unidade Local De Saude Da Regiao De Aveiro E.P.E.
Department Name
#7100:Dermatologia
Principal Investigator Name
Fernando Silva
Principal Investigator Email
fernando.silva.70836@ulsra.min-saude.pt
Contact Person Name
Fernando Silva

Romania

Latest Decision Or Authorization Date
18-11-2024
Number Of Sites
5
Number Of Participants
31

Sites

Site Name
Spitalul Clinic Colentina Bucuresti
Department Name
3302: Hematology
Principal Investigator Name
Viola-Maria POPOV
Principal Investigator Email
violamariap@gmail.com
Contact Person Name
Viola-Maria POPOV
Contact Person Email
violamariap@gmail.com
Site Name
Spitalul Clinic Municipal Filantropia Craiova
Department Name
3305: Hematology
Principal Investigator Name
Luminita OCROTEALA
Principal Investigator Email
diaconu_luminita@yahoo.com
Contact Person Name
Luminita OCROTEALA
Contact Person Email
diaconu_luminita@yahoo.com
Site Name
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Department Name
3307: Hematology
Principal Investigator Name
Anca VASILACHE
Principal Investigator Email
ancavasilache@ymail.com
Contact Person Name
Anca VASILACHE
Contact Person Email
ancavasilache@ymail.com
Site Name
Institutul Regional De Oncologie Iasi
Department Name
3304: Hematology
Principal Investigator Name
Catalin Danaila
Principal Investigator Email
c_danaila@yahoo.com
Contact Person Name
Catalin Danaila
Contact Person Email
c_danaila@yahoo.com
Site Name
Spitalul Clinic Coltea
Department Name
3301: Hematology
Principal Investigator Name
Gabriela Borsaru
Principal Investigator Email
gabriex2001@yahoo.it
Contact Person Name
Gabriela Borsaru
Contact Person Email
gabriex2001@yahoo.it

Bulgaria

Latest Decision Or Authorization Date
15-11-2024
Number Of Sites
2
Number Of Participants
12

Sites

Site Name
Specialized Hospital For Active Treatment Of Hematological Diseases EAD
Department Name
Clinic of Clinical Hematology – Third Department
Principal Investigator Name
Milan Jagurinoski
Principal Investigator Email
dr.jagurinoski@gmail.com
Contact Person Name
Milan Jagurinoski
Contact Person Email
dr.jagurinoski@gmail.com
Site Name
Acibadem City Clinic Tokuda University Hospital EAD
Department Name
2301: Department of Clinical Hematology
Principal Investigator Name
Ismail Amine
Principal Investigator Email
dramine66@gmail.com
Contact Person Name
Ismail Amine
Contact Person Email
dramine66@gmail.com

Spain

Latest Decision Or Authorization Date
18-11-2024
Number Of Sites
9
Number Of Participants
30

Sites

Site Name
Hospital General Universitario Dr. Balmis
Department Name
#7009: Hematología
Principal Investigator Name
María del Carmen García Hernández
Principal Investigator Email
garcia_mcar@gva.es
Contact Person Name
María del Carmen García Hernández
Contact Person Email
garcia_mcar@gva.es
Site Name
University Hospital Son Espases
Department Name
#7014: Oftalmología
Principal Investigator Name
Maria del Carmen Ballester
Principal Investigator Email
mc.ballester@ssib.es
Contact Person Name
Maria del Carmen Ballester
Contact Person Email
mc.ballester@ssib.es
Site Name
Institut Catala D'oncologia
Department Name
#7000: Hematología
Principal Investigator Name
Blanca Xicoy Cirici
Principal Investigator Email
bxicoy@iconcologia.net
Contact Person Name
Blanca Xicoy Cirici
Contact Person Email
bxicoy@iconcologia.net
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
#7007: Hematología y Hemoterapia
Principal Investigator Name
Emilio Ojeda Gutierrez
Principal Investigator Email
bikerpalentino@yahoo.com
Contact Person Name
Emilio Ojeda Gutierrez
Contact Person Email
bikerpalentino@yahoo.com
Site Name
Hospital Quironsalud Zaragoza
Department Name
#7013: Oncologia Medica
Principal Investigator Name
Pilar Giraldo Castellano
Principal Investigator Email
giraldocastellano@gmail.com
Contact Person Name
Pilar Giraldo Castellano
Contact Person Email
giraldocastellano@gmail.com
Site Name
Hospital Universitario Dr Peset Aleixandre
Department Name
#7008: Hematología
Principal Investigator Name
María José Fernández Llavador
Principal Investigator Email
fernandez_mjolla@gva.es
Contact Person Name
María José Fernández Llavador
Contact Person Email
fernandez_mjolla@gva.es
Site Name
Hospital San Pedro De Alcantara
Department Name
#7015: Unidad de Ensayos Clinicos
Principal Investigator Name
Victor Higuero Saavedra
Principal Investigator Email
victor.higuero@salud-juntaex.es
Contact Person Name
Victor Higuero Saavedra
Site Name
Hospital Universitario De Navarra
Department Name
#7010: Hematología
Principal Investigator Name
María Ángeles Goñi Herranz
Principal Investigator Email
agoniher@navarra.es
Contact Person Name
María Ángeles Goñi Herranz
Contact Person Email
agoniher@navarra.es
Site Name
El Hospital Universitario De Gran Canaria Dr. Negrin
Department Name
#7003: Hematologia y Transfusión
Principal Investigator Name
Maria Teresa Gomez Casares
Principal Investigator Email
mgomcasf@gobiernodecanarias.org
Contact Person Name
Maria Teresa Gomez Casares

Italy

Latest Decision Or Authorization Date
18-11-2024
Number Of Sites
8
Number Of Participants
23

Sites

Site Name
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Department Name
3113: S.C. Ematologia
Principal Investigator Name
Monia Marchetti
Principal Investigator Email
monia.marchetti@ospedale.al.it
Contact Person Name
Monia Marchetti
Contact Person Email
monia.marchetti@ospedale.al.it
Site Name
Azienda Ospediera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
3102:S.C.Ematologia U S.S.D. Clinical Trial in Oncoematologia e Mieloma Multiplo
Principal Investigator Name
Giulia Benevolo
Principal Investigator Email
gbenevolo@cittadellasalute.to.it
Contact Person Name
Giulia Benevolo
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
3104: Servizio e DH di Ematologia
Principal Investigator Name
Valerio De Stefano
Principal Investigator Email
valerio.destefano@policlinicogemelli.it
Contact Person Name
Valerio De Stefano
Site Name
Azienda Ospedaliera S Maria Di Terni
Department Name
3105: S.C. di Oncologia Medica e Translazionale / Dipartimento di Oncologia
Principal Investigator Name
Gaetano Vaudo
Principal Investigator Email
vaudogaetano@gmail.com
Contact Person Name
Gaetano Vaudo
Contact Person Email
vaudogaetano@gmail.com
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
3116: Ematologia
Principal Investigator Name
Marianna Caramella
Principal Investigator Email
marianna.caramella@ospedaleniguarda.it
Contact Person Name
Marianna Caramella
Site Name
Azienda USL IRCCS Di Reggio Emilia
Department Name
3108: Ematologia
Principal Investigator Name
Alessia Tieghi
Principal Investigator Email
alessia.tieghi@ausl.re.it
Contact Person Name
Alessia Tieghi
Contact Person Email
alessia.tieghi@ausl.re.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
3109: Ematologia
Principal Investigator Name
Alessandro Lucchesi
Principal Investigator Email
alessandro.lucchesi@irst.emr.it
Contact Person Name
Alessandro Lucchesi
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
3107: SOD Clinica Ematologica
Principal Investigator Name
Serena Rupoli
Principal Investigator Email
serena.rupoli@ospedaliriuniti.marche.it
Contact Person Name
Serena Rupoli

Czechia

Latest Decision Or Authorization Date
14-11-2024
Number Of Sites
2
Number Of Participants
2

Sites

Site Name
Fakultni Nemocnice Hradec Kralove
Department Name
#3005:IV. interni hematologicka klinika
Principal Investigator Name
Petra Belohlavkova
Principal Investigator Email
petra.belohlavkova@fnhk.cz
Contact Person Name
Petra Belohlavkova
Contact Person Email
petra.belohlavkova@fnhk.cz
Site Name
University Hospital Olomouc
Department Name
#3003:Hemato-onkologicka klinika
Principal Investigator Name
Karel Indrak
Principal Investigator Email
indrak@fnol.cz
Contact Person Name
Karel Indrak
Contact Person Email
indrak@fnol.cz

Greece

Latest Decision Or Authorization Date
23-01-2025
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
#9305;1st Propeudetic Internal Medicine Clinic, Hematology Department
Principal Investigator Name
Georgia Kaiafa
Principal Investigator Email
gdkaiafa@yahoo.gr
Contact Person Name
Georgia Kaiafa
Contact Person Email
gdkaiafa@yahoo.gr

Germany

Latest Decision Or Authorization Date
14-11-2024
Number Of Sites
6
Number Of Participants
28

Sites

Site Name
Universitaetsklinikum Aachen AöR
Department Name
#5007:Onkologie und Haematologie
Principal Investigator Name
Steffen Koschmieder
Principal Investigator Email
skoschmieder@ukaachen.de
Contact Person Name
Steffen Koschmieder
Contact Person Email
skoschmieder@ukaachen.de
Site Name
Gemeinschaftspraxis Haematologie Onkologie
Department Name
#5008:Jacobasch, Illmer, Wolf
Principal Investigator Name
Thomas Illmer
Principal Investigator Email
illmer@onkologie-dresden.net
Contact Person Name
Thomas Illmer
Contact Person Email
illmer@onkologie-dresden.net
Site Name
Universitaetsklinikum Halle (Saale) AöR
Department Name
#5005:Klinik für Innere Medizin IV, Hämatologie und Onkologie
Principal Investigator Name
Haifa Al-Ali
Principal Investigator Email
haifa.al-ali@uk-halle.de
Contact Person Name
Haifa Al-Ali
Contact Person Email
haifa.al-ali@uk-halle.de
Site Name
Klinikum rechts der Isar der TU Muenchen AöR
Department Name
#5001:III. Medizinische Klinik
Principal Investigator Name
Peter Herhaus
Principal Investigator Email
peter.herhaus@tum.de
Contact Person Name
Peter Herhaus
Contact Person Email
peter.herhaus@tum.de
Site Name
Universitaetsklinikum Jena KöR
Department Name
#5004:Hämatologie und Onkologie
Principal Investigator Name
Andreas Hochhaus
Principal Investigator Email
andreas.hochhaus@med.uni-jena.de
Contact Person Name
Andreas Hochhaus
Site Name
Kliniken Ostalb
Department Name
#5006:Zentrum Für Innere Medizin
Principal Investigator Name
Holger Hebart
Principal Investigator Email
holger.hebart@kliniken-ostalb.de
Contact Person Name
Holger Hebart

Poland

Latest Decision Or Authorization Date
09-12-2024
Number Of Sites
5
Number Of Participants
50

Sites

Site Name
Pratia S.A.
Department Name
#8009; Centrum Medyczne Pratia Poznan
Principal Investigator Name
Maciej Kazmierczak
Principal Investigator Email
maciej.kazmierczak@onet.eu
Contact Person Name
Maciej Kazmierczak
Contact Person Email
maciej.kazmierczak@onet.eu
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Department Name
#8004; Laboratorium Analityczne
Principal Investigator Name
Piotr Malecki
Principal Investigator Email
piotr.malecki86@gmail.com
Contact Person Name
Piotr Malecki
Contact Person Email
piotr.malecki86@gmail.com
Site Name
Szpital Wojewodzki W Opolu Sp. z o.o.
Department Name
#8002; Oddzial Kliniczny Hematologii, Onkologii Hematologicznej i Chorob Wewnetrznych
Principal Investigator Name
Dariusz Woszczyk
Principal Investigator Email
dariusz.s.woszczyk@gmail.com
Contact Person Name
Dariusz Woszczyk
Contact Person Email
dariusz.s.woszczyk@gmail.com
Site Name
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii
Department Name
#8005; Oddzial Hematologiczny
Principal Investigator Name
Jaroslaw Dybko
Principal Investigator Email
jdybko@dctk.wroc.pl
Contact Person Name
Jaroslaw Dybko
Contact Person Email
jdybko@dctk.wroc.pl
Site Name
Wojewodzki Szpital Specjalistyczny Im. Janusza Korczaka W Slupsku Sp. z o.o.
Department Name
#8007; Oddzial Hematologiczny
Principal Investigator Name
Wojciech Homenda
Principal Investigator Email
wojhom@sl.home.pl
Contact Person Name
Wojciech Homenda
Contact Person Email
wojhom@sl.home.pl

Lithuania

Latest Decision Or Authorization Date
14-11-2024
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Department Name
#8601; Hematology
Principal Investigator Name
Rolandas Gerbutavicius
Principal Investigator Email
gerbrola@yahoo.com
Contact Person Name
Rolandas Gerbutavicius
Contact Person Email
gerbrola@yahoo.com

France

Latest Decision Or Authorization Date
20-11-2024
Number Of Sites
6
Number Of Participants
30

Sites

Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
#4003 Département d’hématologie clinique
Principal Investigator Name
Jean-Christophe Ianotto
Principal Investigator Email
jean-christophe.ianotto@chu-brest.fr
Contact Person Name
Jean-Christophe Ianotto
Site Name
Oncopole Claudius Regaud
Department Name
#4004: Service d’hématologie
Principal Investigator Name
Suzanne Tavitian
Principal Investigator Email
tavitian.suzanne@iuct-oncopole.fr
Contact Person Name
Suzanne Tavitian
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
#4008: Hématologie Clinique
Principal Investigator Name
Etienne Paubelle
Principal Investigator Email
paubelle.etienne@chu-amiens.fr
Contact Person Name
Etienne Paubelle
Contact Person Email
paubelle.etienne@chu-amiens.fr
Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
#4013: Hématologie
Principal Investigator Name
Antoine Machet
Principal Investigator Email
a.machet@chu-tours.fr
Contact Person Name
Antoine Machet
Contact Person Email
a.machet@chu-tours.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
#4007: Service Hématologie Clinique
Principal Investigator Name
Laurent (Ghandi) Damaj
Principal Investigator Email
damaj-gl@chu-caen.fr
Contact Person Name
Laurent (Ghandi) Damaj
Contact Person Email
damaj-gl@chu-caen.fr
Site Name
Hopital Saint Louis
Department Name
#4000: Centre d'Investigations cliniques
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

Hungary

Latest Decision Or Authorization Date
15-11-2024
Number Of Sites
3
Number Of Participants
26

Sites

Site Name
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Department Name
#6006; Hematológiai és Őssejt-transzplantációs Osztály
Principal Investigator Name
Árpád Bátai
Principal Investigator Email
batai.arpad@dpckorhaz.hu
Contact Person Name
Árpád Bátai
Contact Person Email
batai.arpad@dpckorhaz.hu
Site Name
University Of Szeged
Department Name
#6001: Belgyógyászati Klinika
Principal Investigator Name
Borbényi Zita
Principal Investigator Email
borbenyizita@gmail.com
Contact Person Name
Borbényi Zita
Contact Person Email
borbenyizita@gmail.com
Site Name
Szabolcs-Szatmar-Bereg Varmegyei Oktatokorhaz
Department Name
#6004: Hematológiai Osztály
Principal Investigator Name
Rejtő László
Principal Investigator Email
lrejto@med.unideb.hu
Contact Person Name
Rejtő László
Contact Person Email
lrejto@med.unideb.hu

Croatia

Latest Decision Or Authorization Date
09-12-2024
Number Of Sites
2
Number Of Participants
9

Sites

Site Name
Klinicki bolnicki centar Sestre milosrdnice
Department Name
#8703;Dermatologija
Principal Investigator Name
Goran Rincic
Principal Investigator Email
grincic@yahoo.com
Contact Person Name
Goran Rincic
Contact Person Email
grincic@yahoo.com
Site Name
Klinicka bolnica Merkur
Department Name
#8701;Hematologija
Principal Investigator Name
Marko Martinovic
Principal Investigator Email
marko.clinicalstudy@gmail.com
Contact Person Name
Marko Martinovic
Contact Person Email
marko.clinicalstudy@gmail.com

Sponsor

Primary sponsor

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

Contract research organisations

Name
Excelya Greece CRO Single Member S.A.
Responsibilities
codes: [1,12,3,7]
Name
PAREXEL International GmbH
Responsibilities
Medical image analysis/ review - X-ray, MRI, ultrasound, etc., Primary/ surrogate endpoint test, storage and distribution of biological samples
Name
Parexel International (IRL) Limited
Responsibilities
codes: [1,12,2,6,8]
Name
Fisher Clinical Services GmbH
Responsibilities
IMP supply

Third parties

  • {"country":"Greece","full_name":"Excelya Greece CRO Single Member S.A.","duties_or_roles":"codes: [1,12,3,7]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Fisher Clinical Services GmbH","duties_or_roles":"IMP supply","organisation_type":"Pharmaceutical company"}
  • {"country":"Netherlands","full_name":"Eurofins Central Laboratory B.V.","duties_or_roles":"Histopathology, CD34+ , TNF-alpha, IL-6, CRP, GDF-15","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"PK","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Aperio Clinical Outcomes LLC","duties_or_roles":"code: 6","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Study participant travel support","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Germany","full_name":"PAREXEL International GmbH","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc., Primary/ surrogate endpoint test, storage and distribution of biological samples","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"codes: [1,12,2,6,8]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Medical image analysis/ review - X-ray, MRI, ultrasound, etc.","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"code: 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Signant Health Management Limited","duties_or_roles":"Patient reported outcomes device supply, support and data collection","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Primevigilance USA Inc.","duties_or_roles":"code: 8","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Flagship Biosciences Inc.","duties_or_roles":"UGT1A1 genotyping, TP53 induced genes (Nanostring) and MPN gene sequencing","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Celerion Inc.","duties_or_roles":"analysis of CD34+ count samples","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Navtemadlin (grouped formulations: Navtemadlin 25-60; Navtemadlin 10-15; Navtemadlin 25-15; Navtemadlin 10-60; Navtemadlin 25-120; Navtemadlin 25-30)
Active Substance
NAVTEMADLIN
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
Oral
Dose Levels
Navtemadlin 25-60 | Navtemadlin 10-15 | Navtemadlin 25-15 | Navtemadlin 10-60 | Navtemadlin 25-120 | Navtemadlin 25-30

Related trials

Other published trials that may interest you.